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Guidance on Magnetic Resonance 510(k)

[ Price : $8.95]

FDA issues an updated guidance on 510(k) submissions for magnetic resonance diagnostic devices.

FDA Appeals Court Prepopik Ruling

[ Price : $8.95]

FDA appeals a DC district court decision that it acted arbitrarily and capriciously in denying Ferring five-year exclusivity for i...

Neos Therapeutics Files NDA for ADHD Drug

[ Price : $8.95]

Neos Therapeutics files an NDA for its Amphetamine XR oral suspension drug candidate, NT-0201, an attention-deficit hyperactivity ...

Ex-FDAer Settles with SEC Over Insider Trading Scheme

[ Price : $8.95]

Former FDA Office of Generic Drugs deputy director turned consultant Gordon Johnston, who pled guilty in June for being part of an...

Inspector Generals FDA Challenges

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The HHS inspector general describes three drug and medical device management and performance challenges facing FDA and the progres...

FDA Challenges in Implementing Compounding Law: GAO

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The Government Accountability Office says that some states and stakeholders say there have been challenges in FDAs implementation ...

ICH Adopts Clinical Trial Oversight Amendment

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The International Council on Harmonization says an amendment to its good clinical practice guideline encourages sponsors to implem...

Feds Arrest Ex-Pharma Execs Over Fraud/KickBacks

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The federal government arrests former Valeant Pharmaceuticals executive Gary Tanner and former Philidor Rx Services CEO Andrew Dav...

Nonmuscle Invasive Bladder Cancer Guidance

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FDA issues a guidance to help sponsors develop drugs to treat patients with BCG-unresponsive nonmuscle invasive bladder cancer.

Endoceutics NDA Approved for Women with Painful Intercourse

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FDA approves an Endoceutics NDA for Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual inter...