[ Price : $8.95]
CDER issues a MAPP for ANDA filing reviewers on the procedure for communicating with applicants about submissions that contain min...[ Price : $8.95]
FDA launches a new search tool to improve access to data on drug and biologic adverse events through its Adverse Event Reporting S...[ Price : $8.95]
FDA releases a FDA-483 issued to a Dr. Reddys drug manufacturing facility in the UK.[ Price : $8.95]
CDER publishes a MAPP on procedures and responsibilities for Office of New Drug completion and processing of annual status reports...[ Price : $8.95]
FDA releases two documents and plans more steps to help drug compounders register as outsourcing facilities.[ Price : $8.95]
Hyman, Phelps attorneys say that a California federal court rejected a whistleblower suit against Medtronic over fraud-on-FDA and ...[ Price : $8.95]
FDA releases a FDA-483 issued to Aurobindo Pharma following an inspection at its Hyderabad drug manufacturing facility.[ Price : $8.95]
An online blog post looks at possible ways FDA could expand its approach to stem cell clinics marketing products the agency consid...