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Biomedical subjects

J P Santell

Publications and source records attributed to J P Santell.

At least 19 recordsLinked to original sources
PubMed2001

ASHP national survey of pharmacy practice in hospital settings: prescribing and transcribing--2001.

Results of the 2001 ASHP national survey of pharmacy practice in hospital settings that pertain to prescribing and transcribing are presented. A stratified random sample of pharmacy directors at 1091 general and children's medical-surgical hospitals in the United States was surveyed by mail. SMG Marketing Group, Inc., supplied data on hospital characteristics; the survey sample was drawn from SMG's hospital database. The response rate was 49.0%. During 2001, nearly all hospitals are estimated to have pharmacy and therapeutics (P&T) committees that meet an average of seven times per year. It is estimated that more than 90% of P&T committees are responsible for formulary development and management, drug policy development, adverse-drug-reaction review, and medication-use evaluation. More than 90% of hospitals use clinical and therapeutic, cost, and pharmacoeconomic information in the formulary management process, while nearly two thirds consider quality-of-life issues. Nearly 70% use clinical practice guidelines in the formulary management process, and 78% have a medication-use evaluation program designed to improve prescribing. Pharmacists in more than 75% of hospitals provide consultations on drug information, dosage adjustments for patients with renal impairment, antimicrobials, and pharmacokinetics. Further, a majority of hospitals ensure accurate transcription of medication orders by clarifying illegible orders before transcription or entry into medication administration records (MARs), using standardized prescriber order forms, requiring prescribers to countersign all oral orders, and reconciling MARs and pharmacy patient profiles at least daily. In 2001, large hospitals are most likely to use prescriber order-entry systems to improve patient safety and are least likely to require the reentry of medication orders into the pharmacy computer system. The 2001 ASHP survey results suggest that pharmacists in hospital settings have positioned themselves well to improve the prescribing and transcribing components of the medication-use process.

Data Collection↗
PubMed2000

ASHP national survey of pharmacy practice in acute care settings: monitoring, patient education, and wellness--2000.

Results of the 2000 ASHP national survey of pharmacy practice in acute care settings that pertain to patient medication monitoring, education, and wellness are presented. Pharmacy directors at 1063 general and children's medical-surgical hospitals in the United States were surveyed by mail. The response rate was 50.2%. Although the respondents indicated that most pharmacists spent less than 20% of their time on medication-monitoring activities, the amount of time devoted to such activities was increasing. Pharmacists were selective about which patients they chose to monitor for medication-related problems. Patients were frequently chosen on the basis of service or medication. Pharmacists used a number of mechanisms to monitor patients for adverse drug events (ADEs). Although internal ADE reporting had generally increased within the preceding three years, 81% of the Institutions had implemented strategies to improve reporting. When ADEs were reported externally (59% of the respondents), FDA was most commonly alerted. About 92% of the respondents indicated that nursing had primary responsibility for counseling patients about medications. Pharmacists were infrequently involved in medication education during the hospital stay; however, 48% of the institutions used some method to identify patients needing counseling by pharmacists. Slightly more than half of the respondents reported having wellness programs. Pharmacists were most commonly involved in disease-based wellness programs. Pharmacists in acute care settings appear to be well positioned to improve the patient-monitoring, education, and wellness components of the medication-use process.

Adverse Drug Reaction Reporting Systems↗
PubMed2000

ASHP national survey of pharmacy practice in acute care settings: dispensing and administration--1999.

Results of the 1999 ASHP national survey of pharmacy practice in acute care settings that pertain to drug dispensing and administration practices are presented. Pharmacy directors at 1050 general and children's medical-surgical hospitals in the United States were surveyed by mail. The response rate was 51%. About three-fourths of respondents described their inpatient pharmacy's distribution system as centralized. Of those with centralized distribution, 77.4% indicated that their system was not automated. Decentralized pharmacists were used in 29.4% of the hospitals surveyed; an average of 58.9% of their time was spent on clinical, as opposed to distributive, activities. About 67% of directors reported pharmacy computer access to hospital laboratory data, 38% reported access to automated medication-dispensing-unit data, and 19% reported computer access to hospital outpatient affiliates. Only 13% of hospitals had an electronic medication order-entry system; another 27% reported they were in the process of developing such a system. Decentralized medication storage and distribution devices were used in 49.2% of hospitals, while 7.3% used bedside information systems for medication management. Machine-readable coding was used for inpatient pharmacy dispensing by 8.2% of hospitals. Ninety percent reported a formal, systemwide committee responsible for data collection, review, and evaluation of medication errors. Virtually all respondents (98.7%) reported that their staff initiated manual reports. Only two thirds tracked these reports and reported trends to the staff. Fewer than 15% reported that staff were penalized for making or contributing to an error. Pharmacists are making a significant contribution to the safety of medication distribution and administration. The increased use of technology to improve efficiency and reduce costs will require that pharmacists continue to focus on the impact of changes on the safety of the medication-use system.

Ambulatory Care↗
PubMed2000

Projecting future drug expenditures--2000.

Drug cost projections for 2000 and factors that are likely to influence drug costs are discussed. The total increase in drug costs in 2000, assuming there are no major unforeseen events (e.g., Medicare coverage of outpatient prescriptions or important new drugs) can be anticipated to be 12-15% above that in 1999. Prescription drug expenditures are projected to increase an average of 11.2% annually between 1999 and 2001. Although there were fewer new drug approvals in the first half of 1999 than in 1998, we can expect that many new, important, and probably expensive agents will be coming to market in 2000. Analysts calculate that pharmaceutical companies invested approximately $24 billion in research and development in 1999, and there are predictions that mergers within the pharmaceutical industry will reduce the number of major pharmaceutical firms to 13. The introduction of pharmacogenomics is of great interest because of its potential to significantly affect drug therapy and the discovery of new agents. Sales of generic drugs are anticipated to increase from $12 billion in 1999 to $14 billion in 2000. Competition between the brand-name and generic drug industries is intensifying, but it remains unclear whether generic drug pricing will offset brand-name price increases. Internet pharmacy has become a reality and is under federal and state scrutiny. The pharmaceutical and drug distribution industries are changing dramatically, and there is concern that many new prescription drugs will not be readily available to patients because of their high cost. Should this occur, action by the federal government is a possibility.

Drug Approval↗
PubMed1999

ASHP national survey of pharmacy practice in acute care settings: prescribing and transcribing--1998. American Society of Health-System Pharmacists.

Results of the 1998 ASHP national survey of pharmacy practice in acute care settings that pertain to prescribing and transcribing practices are presented. Pharmacy directors at 1058 general and children's medical-surgical hospitals in the United States were surveyed by mail. Data on hospital characteristics were supplied by SMG Marketing Group, Inc.; the survey sample was drawn from SMG's hospital database. The response rate was 51.8%. Respondents reported that at least 90% of hospital and health-system pharmacy and therapeutics (P&T) committees are responsible for formulary development and management, drug policy development, medication-use evaluation, adverse-drug-reaction reporting, and medication error monitoring. More than 90% of the facilities use pharmacoeconomic, clinical and therapeutic, and cost information in formulary development; 83% have a medication-use-evaluation program designed to improve prescribing; more than 95% have P&T committees, infection control committees, and quality control committees; and more than 80% provide pharmacist consultations on drug information, dosage adjustments for patients with renal impairment, antimicrobials, and pharmacokinetics. A majority of respondents reported that accurate transcription of medication orders is ensured by use of standardized physician order forms, clarification of illegible orders, reconciliation of medication administration records (MARs) and pharmacy profiles at least daily, and use of computer-generated MARs. The 1998 ASHP survey results suggest that pharmacists in acute care settings have positioned themselves well to improve the prescribing and transcription components of the medication-use process.

Ambulatory Care↗
PubMed1999

Projecting future drug expenditures--1999.

Drug cost projections for 1999 and factors that are likely to influence drug costs are discussed. The producer price index indicates that the prices of drugs and pharmaceuticals increased sharply, by an average of 10.2%, during the first 10 months of 1998, compared with just 2.1% for all of 1997; the price of pharmaceutical prescription preparations increased by an average of 17.4% in the first 10 months of 1998-an increase of more than six times the average increase for 1997. In the first quarter of 1998, many generic drugs had major price increases. All these increases may be a sign of considerably higher drug costs in 1999. Group purchasing organizations predict price increases in 1999 of 3% for contracted drugs, 5% for noncontracted drugs, and 8% for current and newly marketed drug products. FDA has been able to decrease the time necessary to approve new drugs under the Prescription Drug User Fee Act of 1992 and will be expected to decrease the time even further under the FDA Modernization Act of 1997. Increases of 10-12% or more in managed health care coverage rates are being predicted for 1999, with even larger increases expected for fee-for-service plans. Managed care organizations point to the cost of prescription drugs as the major reason for their rate increases. Last year's prediction that we may be entering a period of smaller increases in drug costs was not fulfilled in 1998; all signs point to even higher drug costs in 1999.

Drug Approval↗
PubMed1998

Projecting future drug expenditures--1998.

Drug cost projections for 1998, factors that directly influence drug costs, and tools for projecting drug expenditures are discussed. The producer price index indicates that prices for drugs and pharmaceuticals increased 2.1% between January and June 1997; the increase for prescription preparations was 2.7%. Medi-Span data show an average increase for all drug products of 1.02% during the first six months of 1997; First Data-Bank reports a 1.7% increase for the same period. IMS America data, which take account of weighting for individual drugs or drug classes, show the prices of all drugs increasing 2.3% between the second quarters of 1996 and 1997. Drug industry analysts project the overall price increase in the next 12 months at 2-4%. Group purchasing organizations predict an average increase over the next 12 months of 0.56% for contracted drugs and 3.6% for noncontracted drugs. Various health care provider indexes suggest that increases in drug costs could be smaller over the next few years. The current trend of takeovers and mergers of pharmaceutical companies and health systems is likely to continue into 1998. As a result of generic competition and the loss of patent protection for many pharmaceutical products, the number of drugs to be introduced onto the market and the number of drugs in development are expected to escalate until the year 2000. These and other major changes in the health care environment, including changes in drug distribution and controversies over the use of formularies, will make future forecasting difficult. Compared with previous years, smaller increases in drug costs have been projected for 1998 and beyond, but changes in the health care environment mean that greater knowledge will be required to forecast future drug expenditures.

Drug Approval↗
PubMed1997

ASHP national survey of pharmacy practice in acute care settings--1996.

The results of the 1996 ASHP national survey of pharmaceutical services in nonfederal community hospitals are presented and compared with the findings of the 1994 ASHP survey. A questionnaire was mailed to pharmacy directors at hospitals randomly sampled from those registered by the American Hospital Association. A total of 713 usable surveys were returned, for a net response rate of 37.1%. Inpatient pharmaceutical services were provided an average of 17.4 hours per weekday and ambulatory care pharmaceutical services 13.3 hours per weekday. Pharmacy directors were more likely to have duties beyond the department than in 1994 (24% versus 12%). The percentage reporting a patient-focused-care model increased from 18% in 1994 to 33% in 1996. The percentage reporting some automation of drug distribution increased from 55% in 1994 to 65% in 1996. Provision of ambulatory care pharmaceutical services was indicated by 63% of respondents, and 35% indicated providing home infusion services. Compared with 1994, pharmacy departments provided more clinical services to inpatients. The most commonly offered clinical pharmacy services for inpatients were drug-food interaction screening, drug-use evaluations, adverse-drug-reaction programs, and medication error management programs. The percentage providing pharmaceutical care to some extent increased from 44% to 60%. The percentage reporting that pharmacists had the authority to initiate or modify medication orders increased from 35% to 56%. A well-controlled formulary system was in place at 60% of hospitals, while 39% reported restrictions on prescribing. Nearly three fourths of respondents reported a therapeutic interchange policy. Mean inventory cost per patient day was $4.67, a decrease from $5.62 in 1994. About 68% of inpatient pharmacy expenditures went for drugs and fluids, 27% for staff, and 5% for other noncapital expenditures. The 1996 ASHP survey revealed continued growth in various activities related to patient care, such as implementation of patient-focused care, enhanced clinical services, and therapy management programs. Although the provision of pharmaceutical care increased, ample room for growth remains.

Ambulatory Care↗
PubMed1997

Projecting future drug expenditures--1997.

Use of the producer price index; data from independent sources, drug industry analyst, group purchasing organizations (GPOs), and health maintenance organizations (HMOs); pharmacoeconomics; and legal developments to project drug expenditures and prepare pharmacy budgets for 1997 is discussed. The producer price index indicates that prices for drugs and pharmaceuticals increased 2.2% during January to May 1996; the increase for prescription preparations was 3.4%. Medi-Span reports an average increase for all drug products of 1.2% for the first six months of 1996. IMS America data show the price of all drugs increasing 1.8% between the second quarters of 1995 and 1996. Drug industry analysts project the overall price increase in the next 12 months at 2.5-5.0%. GPOs predict an average increase over the next 12 months of 2.2% for contracted drugs and 4.3% for non-contracted drugs. HMO pharmacy directors predict pharmacy expenditures will increase by 4.5% per member in 1997. Caution must be applied in using pharmacoeconomics to project drug costs and their impact on health care expenditures. Today's budget must account for the greater integration of drug expenditures into the institution's objectives, possible reductions in other service costs, capitation, competition, shifting of control of the drug budget to specific patient care centers, relocation of services to the ambulatory care setting, and outsourcing. Legal actions in 1996 that may affect price increases and drug budgets included a class-action lawsuit by community and chain pharmacies alleging price discrimination by manufactures and wholesalers. Prices of pharmaceutical products are fairly stable and may remain so in 1997, but projections of future drug expenditures must account for the continuing reshaping of the health care landscape.

Budgets↗
PubMed1996

National survey of quality assurance activities for pharmacy-prepared sterile products in hospitals and home infusion facilities--1995.

The results of a survey of hospital pharmacy and home infusion facility activities for quality assurance in the preparation of sterile drug products are reported, and the hospital results are compared with those of a 1991 ASHP survey. A questionnaire was mailed in May and June 1995 to 778 hospital pharmacy directors and 203 home infusion pharmacy directors. Usable questionnaires were returned by 547 hospitals and 111 home infusion facilities, for an overall response rate of 67%. The percentages of hospitals with pharmacists involved in extemporaneous (70%) and batch (28%) preparation of sterile drug products have decreased since 1991, while the percentage with technicians who are not limited as to the types of sterile products they may prepare has increased. Some 16% of all sterile products compounded in hospitals were prepared by nonpharmacy personnel. Few respondents contracted with outside sources for compounding of sterile products. A need for educational programs on aseptic technique was identified by 83% of hospitals, and 84% of home infusion facilities indicated a need for education on environmental monitoring. Three fourths of respondents used the ASHP Technical Assistance Bulletin on Quality Assurance for Pharmacy-Prepared Sterile Products in developing their policies and procedures. Significant improvements in orientation and training techniques have occurred since 1991. Use of a laminar-airflow hood in a limited-access room has increased. The aspects of sterile product compounding most often modified since 1991 were, for hospitals, personnel training and evaluation (74%), facilities and equipment (48%), and garb policies (36%); for home infusion facilities, personnel training and evaluation (76%), facilities and equipment and garb policies (both 69%), and end-product testing and evaluation (66%). There have been advances in quality assurance procedures related to pharmacy-prepared sterile products, but opportunities for improvement remain.

Drug Compounding↗
PubMed1996

Projecting future drug expenditures--1996.

The use of information on inflation, pharmacoeconomics, generic competition, new drug entities, site-specific drug-use patterns, legislation, and the changing health care environment in the projection of drug expenditures is discussed. Drug price inflation has declined from 6.9% in 1991 to 2.1% for part of 1995. Much of the decline is attributable to deep discounts given by manufacturers to managed care institutions. Some marketing specialists are predicting that drug manufacturers will begin to scale back discounts. Pharmaceutical industry analysts project that overall price increase for pharmaceuticals in the next 12-24 months will average 2.8% (range, 0-6%). Pharmacists need to be able to understand and critically evaluate pharmacoeconomic research, particularly studies conducted by the pharmaceutical industry. Savings due to increases in generic product selection may be offset to some degree by extensions of patent expiration dates under the General Agreement on Tariffs and Trade (GATT). Drug budget projections should include a complete review of new drugs and biotechnology agents pending FDA approval, drugs pending approval for new indications, and common unlabeled uses of expensive existing agents. Various methods are available for tracking drug-use patterns in specific practice settings. When resources are limited, pharmacy managers may elect to target only high-cost drugs; a proactive approach, such as projecting costs and developing guidelines for costly agents before their market release and before consideration by the pharmacy and therapeutics committee, is advantageous. Relevant legislative activities in 1995 included reform proposals for Medicare, Medicaid, and FDA; the Federal Acquisition Streamlining Act; and GATT. Disease management and other approaches to pharmacy benefits have increased opportunities for cooperative arrangements between drug companies and health care providers that may have major effects on drug marketing and pricing. Combining information on inflation, pharmacoeconomics, generics, new drugs, practice-site drug-use patterns, federal legislation, and the changing health care environment is necessary for accurate projections of drug expenditures.

Drug Approval↗
PubMed1995

ASHP national survey of hospital-based pharmaceutical services--1994.

The results of a national survey of pharmaceutical services in federal and nonfederal community hospitals conducted by ASHP during summer 1994 are reported and compared with the findings of earlier ASHP surveys. A simple random sample of community hospitals (federal and nonfederal) was selected from hospitals registered by the American Hospital Association. A questionnaire was mailed to each director of pharmacy. The adjusted gross sample size was 896. The net response rate was 44% (393 usable replies). The mean number of hours that respondents' pharmacies were open per week for inpatient services was 107.5. An increasing number of pharmacy directors were managing other departments within the institution. Of respondents, 18% indicated that a patient-focused-care model was in place. Complete unit dose drug distribution was offered by 92% of respondents, and 67% provided complete, comprehensive i.v. admixture services. A total of 29% provided decentralized inpatient pharmaceutical services. Automation of some type to support drug distribution was used by 55%. Provision of ambulatory care pharmaceutical services was indicated by 82% of nonfederal hospitals and by 98% of federal hospitals. Home infusion therapy services were offered by 27% of respondents. Some 89% had a computerized pharmacy system. The most commonly offered clinical pharmacy services for inpatients were drug-use evaluations and programs to monitor drug therapy, adverse drug reactions, and drug-food interactions. About half of respondents indicated that they did not provide pharmaceutical care. One third indicated that pharmacists had the authority to write drug orders or prescriptions. Pharmacokinetic consultations were provided by 65% and nutritional-support consultations by 35%. Of nonfederal respondents, 86% participated in quality assurance for inpatient dispensing and 28% did so for ambulatory care dispensing. A well-controlled formulary system was in place at 60% of the hospitals. About 74% of inpatient pharmacy expenditures went for drugs and fluids, 20% for staff activities, and 6% for other noncapital expenditures. Almost half of respondents indicated that staff reductions had occurred. About 9% of nonfederal hospitals had an ASHP-accredited residency program. The 1994 ASHP survey revealed a continuation of growth in some areas of hospital pharmacy (clinical services, computerization, formulary management techniques, and residency programs) and identified static areas (ambulatory care services, scope of drug distribution services, and quality assurance programs) that should be addressed by pharmacy leaders.

Ambulatory Care↗
PubMed1995

Projecting future drug expenditures--1995.

Use of information on inflation, pharmacoeconomics, market introduction of new drug entities, practice-site-specific drug-use patterns, federal legislation, and the changing structure of health care delivery to project drug expenditures is discussed. Drug price inflation has been declining over the past several years, from 6.9% in 1991 to 2.2% for part of 1994. This can be attributed to both the growth of managed care and the industry's fear of government price controls. Pharmaceutical industry analysts project the overall price increase for pharmaceuticals in the next 12-24 months to be 2-5%. Pharmacoeconomic research is likely to become increasingly important; pharmacists will need to understand and critically evaluate this research. Drug budget projections should include a complete review of new drugs and biotechnology agents pending FDA approval, drugs pending approval for new indications, and common unlabeled uses of expensive existing agents. Various methods are available for tracking practice-site-specific drug-use patterns; those that categorize expenditures by diagnosis-related group may underestimate total expenditures associated with treating a given condition. State and federal legislation may affect drug rebates, prices, and ultimately drug expenditures. Although health care reform legislation did not pass in 1994, changes are occurring in both the pharmaceutical industry and in health care delivery, shifting the control of drug selection, utilization, and expenditures from individual prescribers to large purchasers. The accuracy of projections of drug expenditures can be improved by examining inflation, pharmacoeconomic research, the introduction of new drug entities, practice-site-specific drug-use patterns, federal legislation, and the changing structure of health care delivery.

Drug Approval↗
PubMed1994

ASHP national survey of pharmaceutical services in federal hospitals--1993.

The results of a national mail survey of pharmaceutical services in federal hospitals conducted by ASHP from May to July 1993 are reported. Mailing lists were compiled of all Air Force, Army, Navy, Public Health Service, and Department of Veterans Affairs (VA) hospitals, as well as some federal prison hospitals. Questionnaires were mailed to each chief of pharmacy. The adjusted gross population size was 326. The net response rate was 76%. Complete unit dose drug distribution was offered by 85% of respondents, and 83% offered complete, comprehensive i.v. admixture programs. About half of the pharmacies provided decentralized services. Over 99% provided services to ambulatory care patients. A computerized pharmacy system was present in 99% of the departments. More than 95% of hospitals participated in adverse drug reaction, medication error management, and drug-use-evaluation programs. A total of 93% provided drug therapy monitoring, and 89% provided patient education. About 70% provided written documentation of pharmacist interventions in the medical records, and 57% participated in drug research. A total of 42% provided pharmacist-managed drug clinics, 41% participated in drug management of medical emergencies, 30% provided written medication histories, and 30% provided drug therapy management planning. Pharmacokinetic consultations were provided by 64% of departments. About 90% had a well-controlled formulary system and prescribing restrictions. Therapeutic interchange was practiced by 64%. Diversified pharmaceutical services included telephone or mail-in refill services (80%), mail-out pharmaceutical services (58%), and services to long-term-care facilities (49%). A total of 70% of the hospitals were affiliated with a pharmacy school. The first ASHP national survey of pharmaceutical services in federal hospitals showed that comprehensive distributive and clinical services were offered by most of the facilities.

Drug Information Services↗
PubMed1994

Projecting future drug expenditures--1994.

The use of information on inflation, generic competition, market introduction of new drug entities, institution-specific drug-use patterns, and federal legislation to project drug expenditures is discussed. Inflation of pharmaceutical prices has been decreasing over the past few years. Increases in the producer price index for drugs and pharmaceuticals diminished from 6.9% in 1991 to 4.3% in the first half of 1993; the specter of government regulation may be one reason. Pharmacy group purchasing organizations (GPOs) predicted that in 1994 expenditures would increase an average of 2.1% for contracted drug items and 8.3% for noncontracted items. Expenditures for biotechnology drugs in January through July 1993 increased 16% over the same period in 1992; such agents are now hospital pharmacies' third most costly drug category, at 10% of total expenditures. Future price competition by generic drug products can be predicted from information on patent or market-exclusivity expiration. To predict the market release of new drug products, new-drug applications filed with FDA can be monitored. The most important component in projecting drug expenditures is a specific institution's pattern of use of high-cost drugs. Mechanisms that can be used to monitor changes in therapeutic strategies and drug-use protocols include drug cost indexes, assessment of drug-use patterns by outside companies, and computerized models for specific high-cost drugs. Drug expenditures can be affected by legislative changes such as the Medicaid rebate provisions of the Omnibus Budget Reconciliation Act of 1990 and the Medicare outpatient drug benefit in the proposed American Health Security Act. The accuracy of projections of drug expenditures can be improved by examining inflation, generic competition, the introduction of new drug entities, institution-specific drug-use patterns, and legislative issues. Pharmacy managers need better methods for estimating institution-specific use of high-cost drugs.

Drug Approval↗
PubMed1993

Projecting future drug expenditures--1993.

The effects of inflation, generic competition, market introduction of new drug entities, and recent legislation on forecasting drug expenditures are discussed. Inflation as it relates to pharmaceutical prices has been decreasing over the past couple of years. The U.S. Bureau of Labor Statistics reported a 6.9% increase in the Producer Price Index for drugs and pharmaceuticals in 1991, diminishing to a 4.5% increase for part year 1992. Pharmaceutical industry analysts predict overall annual inflation rates for pharmaceuticals in 1993-94 will range from 2% to 11%. Explanations for the recent low inflation rates and the wide variance among analysts may include the uncertainty of future government regulation on price increases and the backlog of FDA approvals for biotechnologically derived agents. To evaluate generic competition, information on patent or market exclusivity expiration can be used. The price of a generic drug may be 60-70% of the brand price at market introduction, but it usually stabilizes at approximately 50% of the list price. Predicting the market entry of new drug products is difficult and requires monitoring of (1) filing dates for new drug applications (NDAs) and (2) changes within the FDA approval process. According to an FDA report, the mean time to approval for an NDA in 1991 was 28.5 months and for a new molecular entity was 30.03 months. These figures represent little change from the previous five years.(ABSTRACT TRUNCATED AT 250 WORDS)

Budgets↗