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Par Sues FDA Over Colchicine Exclusivity Forfeiture

[ Price : $8.95]

Par Pharmaceutical files a lawsuit in DC federal court against FDA seeking reversal of an agency decision that revoked Pars eligib...

FDA/CMS Parallel Review is a Bust: New Study

[ Price : $8.95]

A new study finds FDA and CMSs parallel review program has fallen short and failed to address the real obstacles manufacturers fac...

Workshop Planned on Semantic Interoperability of Lab Data

[ Price : $8.95]

FDA and other government agencies plan an 11/8 public workshop on Promoting Semantic Interoperability of Laboratory Data that is i...

Baxter Recalls Compounding Filters

[ Price : $8.95]

Baxter International recalls all unexpired lots of 50mm 0.2 micron filters (product code H93835) due to the potential for a missin...

CDER Report Outlines Drug Safety Research Priorities

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A new CDER drug safety report outlines ongoing research priorities to improve drug safety.

FDA Denies Petition for Action on Unapproved Potassium Chloride

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FDA denies a citizen petition that asked FDA for immediate enforcement action against unapproved potassium chloride oral solution ...

Woodcock Unfit to be CDER Director: Public Citizen

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Public Citizen Health Research Group director Michael Carome says CDER director Janet Woodcock is unfit to serve as CDER director....

SEC Charges Ex-Puma Executive on Insider Trading

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The Securities and Exchange Commission charges the former senior director of regulatory affairs for Puma Biotechnology with inside...

FDA Sets Tropical Disease Voucher Fee at $2.7 Million

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Federal Register Notice: FDA announces the fee rate of $2.7 million for using a tropical disease priority review voucher for fisca...

Rare Pediatric Disease Priority Voucher Fee is $2.7 Million

[ Price : $8.95]

Federal Register Notice: FDA announces the fee rate of $2.7 million for using a rare pediatric disease priority review voucher for...