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Guidance on Registration of Drug Compounding Facilities

[ Price : $8.95]

Federal Register Notice: FDA releases a final guidance: Registration of Human Drug Compounding Outsourcing Facilities Under Sectio...

Guidance on Fees for Compounding Facilities

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Federal Register Notice: FDA releases a guidance: Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 7...

Guidance on E-Reporting for Compounding Outsourcing Facilities

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Federal Register Notice: FDA releases a revised draft guidance: Electronic Product Reporting for Human Drug Compounding Outsourcin...

Workshop Slated on Laboratory Developed Tests

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Federal Register Notice: FDA plans a public workshop 1/8-9/15 on the framework for regulatory oversight of laboratory developed te...

Baxter Recalls 1 Lot of Potassium Chloride Injection

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Baxter International recalls one lot of highly concentrated potassium chloride injection, 10 mEq per 100 mL due to a complaint of ...

Device Makers Need More Cybersecurity Input from FDA: Consultant

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Vree Health compliance officer Paige Joyner says medical device makers need more specific guidelines on what they need to do to he...

FDA Grants ChemoCentryx Orphan Status for CCX168

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FDA grants ChemoCentryx an orphan drug designation for CCX168 for treating atypical Hemolytic Uremic Syndrome.

Panel to Discuss Astellas NDAs for Aspergillosis/Mucormycosis

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Federal Register Notice: FDAs Anti-Infective Drugs Advisory Committee will meet 1/22/15 to discuss Astellas Pharma NDAs for treati...

3 Guidances for Drug Compounding Outsourcing Facilities

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FDA issues three additional guidance documents to assist firms that compound sterile human drugs with registering as outsourcing f...

Allow Links to Risk Info in Social Media Promos, Groups Argue

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Comments on FDAs social media promotions guidance urge the agency to allow direct links to side effect information.