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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

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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...

FDA Guide on Generic User Fee Questions & Answers

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FDA releases a guidance on Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments, a revi...

Panel Backs CMV Device Down-classification

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Microbiology Devices Panel members recommend down-classification of cytomegalovirus viral load devices from Class 3 to Class 2.