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At least 19 recordsLinked to original sources
PubMed1998

Mutual Recognition of the Food and Drug Administration and European Community Member State Conformity Assessment Procedures; pharmaceutical GMP inspection reports, medical device quality system evaluation reports, and certain medical device premarket evaluation reports--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to amend its regulations pursuant to an international agreement that is expected to be concluded between the United States and the European Community (EC) (Ref. 1). Under the terms of that agreement, FDA may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by equivalent EC Member State regulatory authorities and medical device quality system evaluation reports and certain medical device premarket evaluation reports provided by equivalent conformity assessment bodies. FDA is taking this action to enhance its ability to ensure the safety and efficacy of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The agency is requesting comments on the proposed rule.

Device Approval↗
PubMed1998

Mutual recognition of pharmaceutical good manufacturing practice inspection reports, medical device quality system audit reports, and certain medical device product evaluation reports between the United States and the European Community--FDA. Final rule.

The Food and Drug Administration (FDA) is amending its regulations pursuant to an international agreement between the United States and the European Community (EC). The agreement is entitled "Agreement on Mutual Recognition Between the United States and the European Community (MRA). Under the terms of the agreement, the importing country authority may normally endorse good manufacturing practice (GMP) inspection reports for pharmaceuticals provided by the exporting authority determined by the importing authority to have an equivalent regulatory system. Likewise, the importing country authority may normally endorse medical device quality system evaluation reports and certain medical device product evaluation reports by conformity assessment bodies (CAB's) determined by the importing country authority to have equivalent assessment procedures. FDA is taking this action to enhance its ability to ensure the safety and effectiveness of pharmaceuticals and medical devices through more efficient and effective utilization of its regulatory resources. The proposed rule which published in the Federal Register on April 10, 1998 (63 FR 17744), carried an incorrect docket number in its heading. This final rule carries the correct docket number.

Device Approval↗
PubMed1985

Evaluation of pharmacy and therapeutics committee drug evaluation reports.

Pharmacy and therapeutics (P & T) committee drug evaluation reports prepared by pharmacies and drug information centers (DICs) and product package inserts were compared with standard guidelines to evaluate their quality. Letters were sent to 143 hospital pharmacies asking them to submit a previously prepared drug evaluation report on temazepam, moxalactam disodium, or atenolol. The reports and package inserts for these three drugs were evaluated by the presence of 40 elements derived from the published ASHP guidelines for drug evaluation report preparation. Responses were obtained from 124 (87%) pharmacies; however, only 80 reports (60 DIC-prepared and 20 pharmacy-prepared) were received. The reports contained a mean of 28 of the 40 (70%) possible elements. The most frequently omitted elements were AHFS number, potential unlabeled uses, drug-drug interactions, drug-disease-laboratory test interactions, risk and benefit data, prevention and treatment of side effects, comparisons with established treatment, and disadvantages of the drug under consideration. Although the reports prepared by the DICs and pharmacies contained the same amount of information, the DIC-prepared reports included data more frequently on supply sources, therapeutic indications, approved labeling, comparison with established treatment, bioavailability and pharmacokinetics, and recommendations. Most of the reports contained more elements than the corresponding package inserts. The product package inserts did not contain the comparative elements required for P & T committee decisions. Both the pharmacy- and DIC-prepared reports failed to contain all 40 elements recommended in the standard guidelines, suggesting the need for more thorough reports.

Atenolol↗
PubMedDate not supplied

Evaluation report: surgical diathermy units.

A recent issue of 'Health Equipment Information' (No. 122, April 1984) contains evaluation reports on three surgical diathermy units: the Downs Diadon 170, the Martin Elektrotom 500B, and the Olympus PSD-2. In addition to the detailed evaluation reports, 'HEI' 122 also contained a glossary of terms associated with these devices, and a summary of a discussion on the safety of surgical diathermy units presented in a fuller form in 'HEI' 99. A review of the principles and practice of surgical diathermy has recently been published in 'Journal of Medical Engineering & Technology'. Technical aspects of the equipment have been assessed against BS 5724 Part 1, which is the British version of IEC Publication 601-1, in conjunction with a particular standard for surgical diathermy units, IEC 601-2-2, which modifies the general standard. The protocol for the user trials was devised jointly by DHSS, together with local physics staff and surgeons. Orders for 'HEI' 122 (f3.00) to DHSS Leaflets Unit, PO Box 21, Stanmore, Middlesex HA7 1AY, UK. NHS staff can obtain it, free, through their Administrator. For full details of the evaluation findings, readers should consult 'HEI' 122: the following are extracts from the report.

Electrocoagulation↗
PubMedDate not supplied

Evaluation report: defibrillators.

As part of the continuing evaluation programme of medical equipment sponsored by the UK Health Departments, the evaluation of defibrillators is being carried out within the Sheffield and Rotherham District Health Authorities. The following is a version of 'Health Equipment Information' ('HEI') Number 186, published in September 1988, which contains evaluation details on a further five defibrillators. These are the Cardiac Recorders CR26, the Hewlett-Packard HP43120A, the Physico-Control Lifepak 8, the PPG Hellige SCP 852 and the Simonsen & Weel Defi 2. A further model, the Seward Medical 9922 is covered very briefly as it has, as a result of the evaluation, been withdrawn from the market. Earlier summaries of evaluation reports have appeared in 'Journal of Medical Engineering and Technology', together with a review of debrillator design and development.

Electric Countershock↗
PubMedDate not supplied

Evaluation report: infusion pumps and controllers.

A recent edition of 'Health Equipment Information' ('HEI'), Number 175, published in October 1987, contains evaluation reports on a further six infusion devices. These are the Fresenius Injectomat S, the Imed 800, the Sky Electronics PSA 55, the Vi-Tal Vi-Flow, the Braun Dropmat Secura and the Ivac 281 Site Saver. The evaluation was carried out for the Department of Health within the Bath District Health Authority. Technical assessment was carried out by the Bath Institute of Medical Engineering and testing, to BS 5724, at the British Standards Institution.

Equipment Design↗
PubMedDate not supplied

Evaluation report: infusion pumps.

'Health Equipment Information', No. 147, published in October 1985, is the fifth in the series dealing with infusion pumps and contains evaluation reports on five volumetric devices. These are the Braun Infusomat Secura, the Ivac 560, the Ivac Neo-mate 565, the Travenol 6100 and the Travenol 8000. Technical performance assessment was carried out at the Bath Institute of Medical Engineering, and user assessment undertaken at various hospitals within the Bath District Health Authority. For full details of the evaluation findings readers should consult 'HEI' 147 - the following are only extracts from the report. ('HEI' is free to appropriate NHS staff, who should request copies from their Regional or District Administrator. Others can order the journal [pounds 5/copy, cash with order] from DHSS [Leaflets], PO Box 21, Stanmore, Middlesex HA7 1AY, UK.)

Evaluation Studies as Topic↗
PubMed1995

[Health policy goals in child and adolescent health reporting--evaluation with reference to an intermediate-term evaluation].

As a result of the first report on the health of children in Hamburg (1990) 14 primary health policy objectives were identified and related to specific intervention fields. The health information system group at Hamburg has prepared an interim evaluative statement for 1994 on whether and how far each objective has been achieved compared to the targets formulated for the years 1995 and 2000 respectively. 8 out of 14 objectives are considered remaining unchanged as before (i.e. unintentional conception), either proceeding towards the target (i.e. low birth weight, dental health) or having reached the target for 1995 (i.e. infant mortality, age-appropriate vaccination). With 4 objectives the trend deteriorated (i.e. body weight of teenagers, accidents). One objective was monitored on the basis of a new data source (violence against children) and for one objective information could not be proved or updated (breast feeding). In traditional areas of local health policy (i.e. dental health, infant mortality) the health information system and the health targets may be sufficient to help improve the health of the city. In non-lobbied fields (i.e. breast feeding) or those without a consensus on responsibilities (i.e. violence, health and social discrimination) health reports on their own do not invoke achievements, but need to be supported by additional measures.

Adolescent↗
PubMed1998

[Neuropsychiatric aspects of expert evaluation reports after whiplash injury of the cervical spine].

Considerable familiarity with the symptoms of whiplash injury and a knowledge of the risk factors contributing to delayed recovery are requirements for the professionals who write expert reports. In addition, good skills in evaluating the factors influencing pain and illness behavior are necessary, as is the assessment of cognitive performance. Knowing these factors allows as integrative assessment of whiplash patients and is preferably performed by psychiatrists or physicians trained in psychosomatic medicine.

Expert Testimony↗