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Guide on MRI Premarket Notification Submissions

[ Price : $8.95]

Federal Register Notice: FDA announces the availability of a guidance entitled Submission of Premarket Notifications for Magnetic ...

Listing of Drugs Not Withdrawn for Safety/Effectiveness Reasons

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Federal Register notice: FDA determines that the drug products listed in this notice were not withdrawn from sale for reasons of s...

Draft Guide on Bladder Cancer Drug Development

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Federal Register Notice: FDA has made available a draft guidance on Bacillus Calmette-Guerin (BCG) Unresponsive Nonmuscle Invasiv...

Guidance on Magnetic Resonance 510(k)

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

FDA Appeals Court Prepopik Ruling

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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

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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...