Newsletter Vol.32, no. 32

Nesete Pharmaceutical Manufacturers Association Editor: Duffy Miller N u m b e r 3 2 1 1 1 1 1 1 I 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 I I ( 2 0 2 ) 8 3 5 - 3 4 6 8 Volume 32, Number 3 1 N um109.54031 ier 32 5571095t~~~~~~~~ ~2n2~ln s.05~m~~m04.023 August 20, 1990 RAIDS ON NDA REVIEWERS TO STAFF GENERICS COULD ESCALATE, PECK SAYS So far, "the extent of the raid" on NDA staff to help expedite generic approvals has been "modest, only a handful" of chemists and other reviewers, Center for Drug Evaluation & Research director Carl Peck said last week. "However, (under) increasing pressure -- urgency -- to solve the backlog of ANDAs, we are contemplating expansion" of the shifts. Some NDE programs could be identified as "having been slowed." Peck described "the tug and pull of deciding what is more important: pushing new drugs through" or increasing the number of generics. "We will do everything we can (to protect) AIDS and cancer (NDAs), but I can't assure any other" new drug divisions will not be hurt. NO STOPGAP MEASURES, LASAGNA COMMITTEE RECOMMENDS BASIC FDA CHANGES President George Bush took time from the Middle East and budget crises last Wednesday to meet with Armand Hammer. Hammer, titular head of the National Committee to Review Current Procedures for Approval of New Drugs for Cancer & AIDS, presented Bush with his committee's final report. (The study responded to a 1988 request from then-Vice President George Bush, acting as chairman of the Presidential Task Force on Regulatory Relief. The committee's name defines its purpose.) Hammer, committee chairman Louis Lasagna and National Cancer Institute's Samuel Broder then discussed their findings with the press. "We attempted to identify barriers to rapid availability" of new AIDS and cancer therapies, Lasagna told reporters. And there is "definite progress," he continued: "closer cooperation between FDA and NIH," "a closer FDA-commercial sponsor working relationship," and "increased flexibility on endpoints." But, Lasagna later said, "FDA is inconsistent on accepting surrogate endpoints" and while the agency publicly maintains that sponsors are responsible for slow approvals, in private some admit "it is not true that the only problem is filing." Basic, formal changes are needed to expedite approval of cancer and AIDS therapies, the committee felt. It recommended these: 1100 Fifteenth Street, N.W Washington, D.C. 20005 (202) 835-3400

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Title
Newsletter Vol.32, no. 32
Author
Pharmaceutical Research and Manufacturers of America
Canvas
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Pharmaceutical Manufacturers Association
1990-08-20
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newsletters
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newsletters

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"Newsletter Vol.32, no. 32." In the digital collection Jon Cohen AIDS Research Collection. https://name.umdl.umich.edu/5571095.0504.023. University of Michigan Library Digital Collections. Accessed June 10, 2025.
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