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Biomedical subjects

S L Nightingale

Publications and source records attributed to S L Nightingale.

At least 163 records · Page 9Linked to original sources
PubMed1988

The FDA's new procedures for the use of investigational drugs in treatment.

The Food and Drug Administration has established new procedures to make promising investigational drugs available for treatment of patients with immediately life-threatening or serious diseases as early in the drug development process as possible and well before general marketing begins. The purpose of this article is to inform the medical community about these new procedures and to facilitate their implementation. Examples of immediately life-threatening and serious diseases are given and the procedures that physicians should use to obtain a drug under the new regulations are described. The treatment use of zidovudine (Retrovir), while still in the investigational phase, is described as a case study. The article also summarizes the Food and Drug Administration's new procedures under which drug sponsors can charge for investigational drugs.

Acquired Immunodeficiency Syndrome↗
PubMed1987

Generic drugs and the prescribing physician.

While generic substitution is not a new phenomenon, a number of factors have combined to markedly increase generic drug use. The most important factor is a 1984 law, the Drug Price Competition and Patent Term Restoration Act, which facilitates the entry into the marketplace of generic versions of brand name drugs. This law and Food and Drug Administration (FDA) policies are designed to approve for marketing generic drug products that are therapeutically equivalent to their brand name counterparts. With increased availability of generic drugs, physicians have expressed the need for more information about the FDA process for determining that generic versions of brand name drug products are both safe and effective and that generic drug products will produce the same therapeutic results as those achieved by the brand name products. This article describes FDA procedures for approving generic drug products and examines issues important to the prescribing physician, in particular, therapeutic equivalence. The article also describes the role of the states in generic substitution and the availability of information from the FDA on the therapeutic equivalence of drug products.

Drug Prescriptions↗
PubMed1987

Regulatory overview: protection of human subjects--IRBS and informed consent.

The Food and Drug Administration (FDA) regulations on Institutional Review Boards (IRBs) and Informed Consent (IC) were published on January 27, 1981 and became operational on July 27, 1981. The historical development of these regulations began in August 1978 when the FDA proposed standards for IRBs. During the comment period, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted its report and recommendations on IRBs and informed consent. In its report, the National Commission recommended revision of the Department of Health and Human Services (DHHS) regulations and one uniform standard for IRBs. On August 14, 1979, the FDA withdrew the 1978 proposal and published a revised proposal that it had developed in conjunction with the DHHS in response to the recommendations made by the National Commission. Following consideration of the comments received on the 1979 proposal, the new regulations were published as final. I would like to discuss how these regulations relate to the FDA's mandate and regulatory responsibilities, to the work of IRBs, and to the protection of human subjects involved in the FDA-regulated research. I will also mention the FDA's internal organization to deal with IRB issues and, finally, what we may look forward to in the future.

Drug Evaluation↗
PubMed1986

Orphan drugs.

Explore the source record for details and available documents.

Caprylates↗
PubMed1983

Do physicians tell patients enough about prescription drugs? Do patients think so?

It seems likely that consumer experience in receiving information about prescription drugs will change significantly as a result of the efforts of various professional, governmental, industrial, and voluntary organizations. Two surveys sponsored by the Food and Drug Administration compose part of these efforts. One provides a picture of how patients believe they are being informed about the drugs prescribed for them, what kinds of information they are getting, and what sources they use to obtain information; the other yields data concerning the physicians' and pharmacists' perspective. The two surveys point up intriguing and important differences between patients' and health care providers' perceptions of the drug information process.

Communication↗
PubMed1978

How laetrile laws affect MDs.

A variety of problems exist in the 17 states that have passed laetrile laws. The precise legal relationship of these statutes to state food and drug laws and state medical practice acts is not well defined. The variability of the laws, state to state, is great and substances other than laetril are sometimes involved. The passage of substance-specific legislation confers "pseudo-approval" status on that substance in the public's mind. This results in a shifting of the drug approval process away from normal health regulatory channels into the political arena. Physicians should become familiar with the legal, medical, and social implications of such laws in their own states. More importantly, they need to articulate clearly to legislators the inherent problems and dangers in passing such legislation.

Amygdalin↗