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FDA Withdraws 8 NADAs

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Federal Register Notice and Final rule: FDA withdraws approval of eight NADAs and amends the animal drug regulations to reflect th...

Info on Special Protocol Assessment Sent to OMB

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Federal Register Notice: FDA sends a proposed collection of information on a guidance on special protocol assessment to the Office...

Panel Meeting Adds Foodborne Outbreaks to Discussion

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Federal Register Notice: FDA amends its 11/8-9 Risk Communication Advisory Committee meeting agenda to include a discussion of foo...

Panel to Hear Updates on Tumor Vaccines and Biotechnology Branch

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Federal Register Notice: FDAs Cellular, Tissue and Gene Therapies Advisory Committee will meet 12/14 via teleconference to hear up...

Tobacco Products Panel to Meet

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Federal Register Notice: FDAs Tobacco Products Scientific Advisory Committee will meet 11/18.

FDA Withholds Approval of BMS Drug Over GMP Issues

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FDA withholds approval of Bristol-Myers Squibb's belatacept, a biologic product indicated for preventing transplanted organ rejec...

Small Risks Dont Warrant 510(k) Upheaval: White Paper

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A California Healthcare Institute white paper reports fewer than half a percent of 510(k)-cleared medical devices are involved in ...

Glaxo Hit With $750 Million Fine Over Puerto Rico Troubles

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GlaxoSmithKline and its subsidiary SB Pharmco agree to plead guilty and pay $750 million to settle charges that they made and ship...

Generic Drug Industrys Jaeger Joins Pharmacy Group

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Former Generic Pharmaceutical Association CE Kathleen Jaeger is named the new head of the National Community Pharmacists Associati...

Grassley Quizzes Hamburg on FDA Conflict Rules

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Senate Finance Committee ranking member Charles Grassley asks FDA how far beyond the broad requirements of its regulations does it...