CDER issues a MAPP for ANDA filing reviewers on the procedure for communicating with applicants about submissions that contain minor technical deficie...
FDA launches a new search tool to improve access to data on drug and biologic adverse events through its Adverse Event Reporting System.
FDA releases a FDA-483 issued to a Dr. Reddys drug manufacturing facility in the UK.
CDER publishes a MAPP on procedures and responsibilities for Office of New Drug completion and processing of annual status reports on sponsor postmark...
FDA releases two documents and plans more steps to help drug compounders register as outsourcing facilities.
Hyman, Phelps attorneys say that a California federal court rejected a whistleblower suit against Medtronic over fraud-on-FDA and off-label promotion ...
FDA releases a FDA-483 issued to Aurobindo Pharma following an inspection at its Hyderabad drug manufacturing facility.
An online blog post looks at possible ways FDA could expand its approach to stem cell clinics marketing products the agency considers to be unapproved...