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Draft Guide on Noncirrhotic Nonalcoholic Steatohepatitis Drugs

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibros...

Guide on ANDA Post-Complete Response Letter Meetings

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Post-Complete Response Letter Meetings Between FDA and ANDA...

ev3 Agrees to Plead Guilty and Pay $18 Million

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The U.S. Justice Department announces that medical device manufacturer ev3 has agreed to plead guilty to introducing an adulterate...

FDA Collaborative Communities Update

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FDA says CDRH is making progress on its strategic goal to facilitate development of collaborative communities.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Barox Co., Globus Medical and MiBo Medical Group.

FDA Proposes De Novo Pathway Changes

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FDA issues a proposed rule to change the submission and review requirements for the medical device de novo classification pathway.

FDA-483 Issued to JCB Laboratories

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FDA posts a Form FDA-483 citing JCB Laboratories over GMP deficiencies at the drug outsourcing operation.

Info Collection Extension for e-Adverse Event Reports

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Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Adverse Event Reports; Electronic ...

Draft Guide on Noncirrhotic Nonalcoholic Steatohepatitis

[ Price : $8.95]

FDA releases a draft guidance entitled Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatme...

Guidance on ANDA Post-complete Response Meetings

[ Price : $8.95]

FDA posts a guidance entitled Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.