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Error Corrected in Proposal for Cardiovascular Electrodes

[ Price : $8.95]

Federal Register Proposed rule correction: FDA corrects an Internet address in an 8/8 Federal Register proposed rule requiring a P...

Opana ER Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Opana ER 7.5 mg and 15 mg were not withdrawn from sale for reasons of safety or effec...

Talwin Compound Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that Talwin Compound tablets 325 mg were not withdrawn from sale for reasons of safety or ...

FDA Does Not Approve Migraine Patch

[ Price : $8.95]

FDA sends NuPathe a complete response letter on an NDA for Zelrix (sumatriptan), a transdermal patch for treating migraine headach...

FDA Finds CGMP Problems at Nanjing Biotech

[ Price : $8.95]

FDA warns Nanjing Biotech of CGMP problems at its China drug manufacturing facility.

FDA Accepts sNDA for Relsitor

[ Price : $8.95]

FDA accepts for review a Progenics Pharmaceuticals supplemental NDA for Relistor (methylnaltrexone bromide) Subcutaneous Injection...

FDA Issues Tablet Scoring Guidance

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FDA issues a guidance on evaluating and labeling scored drug tablets.

FDA 'Mini Sentinel' Pilot Up and Running

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FDA says a pilot program testing its Sentinel product surveillance system is up and running.

FDA, Talon Agree on Special Protocol for Marqibo

[ Price : $8.95]

FDA and Talon Therapeutics reach agreement regarding a special protocol assessment for a planned Phase 3 study of Marqibo (vincris...

Group Petitions FDA on Generic Makers Need to Update Warnings

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Public Citizen petitions FDA seeking to require generic drug makers to update product labeling to warn patients about risks associ...