CBER posts Instructions for Using the Electronic Human Cell and Tissue Establishment Registration System (eHCTERS).
Federal Register notice: FDA posts a list of eight information collections that have been approved by OMB.
CDER says reorganization of the Office of New Drugs moved into Phase 2 11/4.
FDA releases an FDA-483 with seven observations issued following an inspection at Innoveix Pharmaceuticals.
Biopharma Reporter says that Pfizer CEO Albert Bourta is leading the effort to reform drug company rebates to payers that he says are slowing uptake o...
Four stakeholders praise and recommend changes to an FDA draft guidance on general clinical pharmacology considerations for neonatal studies for drugs...
CDER has completed reorganization of the Office of Hematology and Oncology Products into the Office of Oncologic Diseases.
FDA posts for comment a draft document with best practices for agency staff in conducting postmarket safety surveillance of drugs and biologics.