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FDA releases a draft guidance entitled Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.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