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FDA releases a draft guidance entitled Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.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.
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Regeneron Pharmaceuticals Kevzara (sari...
Federal Register notice: FDA determines for patent extension-related purposes the regulatory review period for Provepharms Provayblue (methylene blue)...
AdvaMed and other industry groups comment on FDAs recent draft guidance on The Special 510(k) Program, suggesting that the documents proposed text may...