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FDA Study Finds Maternal BPA Safe for Rat Fetuses

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A new FDA study finds no detectable levels of the suspected mutagen bisphenol A in the fetuses of pregnant rats orally administere...

FDA Regulatory Bias on 'Fasting State' with Cancer Drugs?

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A Journal of Clinical Oncology commentary criticizes an alleged FDA regulatory bias against requiring cancer-treating drugs to be...

HHS Defends Purdue Execs Exclusion

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HHS tells an appeals court it acted properly in excluding former Purdue executives from participating in federal healthcare progra...

Opposing Abolition, FDA Still Considering 510(k) Changes

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FDA tells industry representatives during MDUFA 3 negotiations that it is still against scrapping the 510(k) program as it continu...

Public, Industry Want More Foreign Drug Inspections: Pew

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Allan Coukell and Patricia Benson say that Congress should move quickly to help FDA conduct more inspections of foreign drug and A...

FDA Collaborating In Drug Toxicity Chip Development

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FDA says it will provide scientific and technical input to NIH and DARPA in a collaborative effort to develop a chip that can sign...

Revised Guidance on Marketing Unapproved Drugs

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Federal Register Notice: FDA releases a revised guidance on how it intends to exercise enforcement discretion for drug products ma...

Pediatric Subcommittee to Discuss Anticoagulant Products

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Federal Register Notice: FDAs Pediatric Oncology Subcommittee will meet 11/2 to discuss developing anticoagulant products in child...

FDA Revamping Product Recall Process and Policies

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FDA Office of Enforcement acting director Armando Zamora says the agency is revamping its outdated product recall policies and pro...

FDA Approves Amphastar Generic Lovenox

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After years of contention, FDA approves Amphastars ANDA for a generic form of Lovenox.