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FDA Orphan Designation for Duchenne Therapy

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FDA grants Catabasis Pharmaceuticals an orphan drug designation for CAT-1004 for treating Duchenne muscular dystrophy.

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.

Comments Sought on Animal Food/Feed Prohibited Substances

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Federal Register Notice: FDA seeks comments on recordkeeping for animal food/feed prohibited substances.

Guidance on Changes to Blood Product Application

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Federal Register Notice: FDA releases a guidance: Changes to an Approved Application: Biological Products: Human Blood and Blood C...

FDA Corrects Notice on REMS

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Federal Register Notice: FDA corrects the name of an organization a 9/23 notice on report on the standardization of risk evaluatio...

Workshop on Drug Development and Rare Subsets of Patients

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Federal Register Notice: FDA plans a public workshop 12/12 on developing therapies in the omics era and using rare subsets of pati...

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...

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...