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Comments Sought on Electronic Device Registration

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on information collection associated with electronic device registration and listing.

Guidance on Compounding Bulk Drugs by Outsourcing Facilities

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Federal Register Notice: FDA releases a draft guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503...

Guidance on Compounding Using Bulk Drugs Under 503A

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Federal Register Notice: FDA releases a draft guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503...

FDA Exempts Gene Mutation Detectors from 510(k)

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Federal Register Notice: FDA intends to exempt autosomal recessive carrier screening gene mutation detection systems from premarke...

Panels to Discuss Codeine Use in Children

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Federal Register Notice: FDAs Pulmonary-Allergy Drugs and the Drug Safety and Risk Management Advisory Committees will meet 12/10 ...

FDA, Pacira in Settlement Talks About Off-label Promotion

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FDA and Pacira Pharmaceuticals enter settlement talks to resolve a recent lawsuit or narrow the dispute brought against the agency...

FDA Finalizes Animal Rule Guidance

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FDA finalizes a guidance on product development under the Animal Rule when human efficacy studies are not ethical or feasible.

QS Problems in Aros Surgical Inspection

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FDAs Los Angeles District Office warns Aros Surgical Instruments about Quality System and other violations in its manufacturing of...

Gene Mutation Detector into Class 2

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Federal Register Final order: FDA classifies an autosomal recessive carrier screening gene mutation detection system into Class 2.

Activists Take Anti-Essure Campaign to Congress

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Women claiming injuries from Bayer Healths Essure permanent birth control device are delivering 435 packets of information to ever...