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FDA Lists October Drug Safety Alerts

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FDA tells consumers about drug safety alerts issued in October.

Hearing on Nicotine Replacement Therapies

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Federal Register Notice: FDA plans a public hearing 12/17 to discuss applicable approval mechanisms and additional indications for...

OMB OKs Info on Tobacco Product Registration

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on registration and product...

FDA to Act Against Unapproved Anti-Cyanide Poisoning Products

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Federal Register Notice: FDA intends to take enforcement action against unnaproved injectable drugs for treating cyanide poisoning...

FDA Withdraws Smokeless Tobacco Product Guidance

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Federal Register Notice: FDA withdraws an outdated guidance, Enforcement Policy Concerning Rotational Warning Plans for Smokeless ...

Meeting on State/Federal Roles in Pharmacy Compounding

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Federal Register Notice: FDA plans a public meeting 12/19 on state and federal roles for pharmacy compounding.

Despite Patient Deaths, Rx Compounder Gets Slap on the Wrist

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A Texas drug compounding operation and its owner get probation in a 2007 deadly compounding episode that allegedly caused three de...

9 Lots of Isovue Syringes Recalled

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Bracco Diagnostics recalls nine lots of Isovue pre-filled syringes due to the presence of visible particles.

FDA Accepts Aveo/Astellas NDA for Tivozanib

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FDA accepts an Aveo Oncology and Astellas Pharma NDA for tivozanib, indicated for treating patients with advanced renal cell carci...

OIG Could Modify Corp. Integrity Agreements: Law Firm

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Ropes & Gray attorneys say two HHS Inspector General roundtables this year on pharmaceutical company compliance with corporate int...