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FDA, Canada Public Meeting on ICH Activities

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Federal Register notice: FDA announces a 10/17 regional public meeting entitled U.S. Food and Drug Administration and Health Canad...

Silver Star Brands Recalls Contaminated Products

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Silver Star Brands recalls six products for humans (including four Native Remedies and two Healthful Naturals and two PetAlive pro...

NJ Court Backs Accutane Case Dismissals

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The New Jersey Supreme Court dismisses 532 failure-to-warn cases alleging that Roche failed to provide adequate warnings about the...

Stakeholders Back Meeting Pilot Program

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Two stakeholders praise an FDA pilot meeting program for complex innovative drug trial designs.

Allergan Expanded Use Cleared for CoolSculpting

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FDA clears an Allergan 510(k) for its CoolSculpting nonsurgical fat reduction device to treat the submandibular (below the jawline...

FDA OKs Genentechs Hemlibra for Some Hep A

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FDA approves Genentechs Hemlibra for a new prophylaxis indication for hemophilia A in patients without factor VIII inhibitors.

Withdraw Drug Dissolution Guidances: Researcher

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A citizen petition asks FDA to withdraw drug dissolution guidances and the dissolution database because dissolution testers have n...

Consider DaVinci Cautery Instrument Ban: Petition

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Unplug the Robot activist Jennifer Nelson asks FDA to consider banning and recalling all DaVinci Robot permanent cautery instrumen...

Guide on Drug Packaging and Labeling Terms

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Federal Register notice: FDA makes available a final guidance entitled Selection of the Appropriate Package Type Terms and Recomme...

Draft Guide on ANDA Blocking Petitions

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Federal Register notice: FDA makes available a draft guidance entitled Citizen Petitions and Petitions for Stay of Action Subject ...