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Federal Register Notice: FDA releases a draft guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503...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Federal Register Notice: FDA releases a draft guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503...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

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...

FDA Clears Pryor Medical ER-REBOA Catheter

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FDA clears a Pryor Medical Devices 510(k) for the ER-REBOA (Resuscitative Endovascular Balloon Occlusion of the Aorta) catheter fo...

FDA Panel Backs AstraZeneca Gout Drug

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FDAs Arthritis Advisory Committee votes 10 to 4 to recommend approval of AstraZenecas lesinurad oral tablets for treating hyperuri...

CDRH Sees More IDE 1st Cycle Approvals with Pre-submissions

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CDRH says a recent analysis of IDE pre-submissions showed that IDEs submitted after a pre-submission have a greater likelihood of ...

Medical Policy Acting Director Jarow Moves to Center Office

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CDER Office of Medical Policy (OMP) acting director Jonathan Jarow leaves his post to join the Office of the Center Director due t...

FDA Issues Interim Policy on Drug Compounding

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A new FDA interim policy on drug compounding indicates that the agency does not intend to take an enforcement action under certain...