Abstracts » Health

Speedier drug approvals; critics ask: is FDA record a result of reform, or just a blip?

Article Abstract:

The Food and Drug Administration (FDA) approved 41 breakthrough drugs through November 1996, 13 more than were approved in 1995. In the fiscal year ended September 30, 1996, the FDA approved 46 breakthrough drugs. Breakthrough drugs are new molecular entities containing active ingredients previously unmarketed in the given country. The median review time for breakthrough drugs approved by both the FDA and the European Union was 5.8 months in the U.S. and 12.2 months in Europe.

Regulation of Agricultural Marketing and Commodities, Food & Drug Administration, Regulation of agricultural marketing, Drug approval

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FDA wants to overhaul over-the-counter drug labels

Article Abstract:

The Food and Drug Administration (FDA) has published rules for clarifying and standardizing nonprescription drug labels, with finalization set for later in 1997. Labels on over-the-counter drugs, which are increasingly being used by patients in lieu of and supplementary to prescription drugs, would include clearer and simpler language, such as "lung" instead of "pulmonary". The FDA proposals would give manufacturers until 1999 or 2000 for implementation.

Proprietary Preparations, Regulation, Licensing, and Inspection of Miscellaneous Commercial Sectors, Packaging & Labeling Regulation, Proprietary drugs, Commercial law, Labels, Nonprescription drugs

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Generic drugmakers fight patent extensions

Article Abstract:

Opponents say that they will fight an FDA ruling that structures the implementation of GATT provisions that extend the patents of over 109 drugs. The extensions will cost healthcare payers over $7.4 billion, due to the unavailability of generic alternatives to the protected drugs, according to the University of Minnesota's PRIME Institute. Sen David Pryor said that he will introduce legislation to address the situation.

Other Justice, Public Order, and Safety Activities, Ethical Preparations, Patent Law, Economic aspects, Pharmaceutical industry, Drugs, Intellectual property, Generic drugs

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