Drugs, reviews

Over-the-Counter Drug Review begun to enhance the safety, effectiveness and appropriate labelling of drugs sold without prescription. 

Kuehn, B.M. FDA speeds smoking cessation drug review. JAMA 8 295(6), 614, 2006. 

Over-the-Counter Drug Review, 18 685 Over/under scales, 26 252 Overvoltage, 12 206-207, 214 mass transport (concentration),... 

Food and Drug Administration (1966). Guidelines for Reproduction Studies for Safely Evaluation of Drugs for Human Use. Drug Review Branch, Division of Toxicological Evaluation, Bureau of Science, Food and Drug Administration, Washington, D.C. 

Over-the-cormter (OTC) drug review begins to ensure the safety, effectiveness, and appropriate labeling of drugs sold without prescription. Regulation of biologies (serums, vaccines, and blood products) is transferred from NIH to FDA. 

Ironically, by the time DSHEA was enacted, the OTC drug review had rid the marketplace of nearly all fhe sfandard OTC products that had been marketed with unsubstantiated claims. In contrast, few diefary supplements promoted with disease-related claims can live up to such claims. A few years ago, a review of 964 herbs and diefary supplemenf products listed in the Natural Medicines Comprehensive Database found fhaf only 15% had been proven safe and only 11% had been proven effective for the indications for which fhey were advocafed. ... 

In some circumstances, the FDA processes drug reviews under the accelerated scheme. This mechanism is to review and approve drugs speedily for cases where effective therapies are lacking or in situations of rare diseases. One of the fastest approval times to date is the case of imatinib mesylate (Gleevec, Novartis—Exhibit 7.3) for the treatment of chronic myeloid leukemia (CML) it was approved in less than 3 months after the filing of an NDA with the FDA. Another example is the new AIDS drug indinavir (Crixivan, Merck), which was approved in a mere 42 days. 

After 1962, still more rules were adopted to insure ironclad control from the top. The Surgeon General and Chief of the Chemical Corps were added to the decisionmaking hierarchy. Committees and Review Boards replaced individual reviewers. The Army Investigational Drug Review Board provides an insfructive example. 

The Human Use Review Office was charged with administering and coordinating activities of the Army Investigational Drug Review Board, the U.S. 

By the early 1980s, all of the FDA panels had completed their deliberations and issued their reports. Because the industry largely followed the conclusions and recommendations of these reports, most of the impact of the OTC Drug Review had already been reflected in the marketplace. Nonetheless, a number of monographs remain to be completed and it will be some years before the OTC Drug Review is fully finished. 

In response to demands to accelerate the drug review process, however, the FDA perceived opportunities to use the IND process to improve the chances that the subsequent NDA would answer the essential regulatory questions, or eliminate them by answering these questions... 

Briley, M. (1998). Milnacipran, A Well-Tolerated Specific Serotonin and Norepinephrine Reuptake Inhibiting Antidepressant, CNS Drug Reviews, 4 137-148. 

Hachad, H., Ragueneau-Majlessi, I., and Levy, R.H. (2002) New antiepileptic drugs review on drug interactions. Drug Monit 24 91-103. 

Nyberg, S., Nakashima. Y.. Nordstrom, AX., et aL Positron emission tomography of in-vivo binding characteristics of atypical antipsychotic drugs. Review of D2 and 5-HT2 receptor occupancy studies and clinical response. Br. J. Psychiatry 168 (SuppL 29), 40-44, 1996. 

Pinco R. Implications of FDA s proposal to include foreign marketing experience in the over-the-counter drug review process. Food Drug Law J 1998 53 105-122. 

For details of the Guidance, the readers are referred to the official FDA website for botanical drug review (1). 

Meadows, Michelle. The FDAs Drug Review Process Ensuring Drugs Are Safe and Effective. FDA Consumer 36, no. 4 (July/August 2002) ... 

The FDA s magazine describes the 12-step process of a drug review in terms that consumers can easily understand. The theme is that the careful review process protects the safety of prescription drug users. 

The FDA s Drug Review Process Ensuring Drugs Are Safe and Effective... 

Reviewers receive training that fosters consistency in drug reviews, and good review practices remain a high priority for the agency. 

Some considerations would be if it s a drug that has significant questions, if it s the first in its class, or the first for a given indication, says Mark Goldberger, M.D., director of one of CDER s drug review offices. Generally, FDA takes the advice of advisory committees, but not always, he says. Their role is just that—to advise. ... 

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