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Federal Register notice: FDA makes available a draft guidance entitled Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibros...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Post-Complete Response Letter Meetings Between FDA and ANDA...[ Price : $8.95]
The U.S. Justice Department announces that medical device manufacturer ev3 has agreed to plead guilty to introducing an adulterate...[ Price : $8.95]
FDA says CDRH is making progress on its strategic goal to facilitate development of collaborative communities.[ Price : $8.95]
FDA releases its latest batch of Warning Letters that include Barox Co., Globus Medical and MiBo Medical Group.[ Price : $8.95]
FDA issues a proposed rule to change the submission and review requirements for the medical device de novo classification pathway.[ Price : $8.95]
FDA posts a Form FDA-483 citing JCB Laboratories over GMP deficiencies at the drug outsourcing operation.[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Adverse Event Reports; Electronic ...