FDA posts a guidance entitled Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and ...
FDA requests updated chemistry, manufacturing and controls information on Genentechs subcutaneous formulation of lung cancer drug Tecentriq (atezolizu...
In what is a likely sign of increasing interest on Capitol Hill, the Government Accountability Office releases a new report examining FDA and FTC over...
Federal Register notice: FDA announces an 11/17 Pulmonary-Allergy Drugs Advisory Committee to review a Merck NDA for gefapixant oral tablets.
Federal Register notice: FDA plans an 11/9 public meeting entitled Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation....
Abortion drug distributor Danco Laboratories petitions the U.S. Supreme Court to review last months decision by the Fifth Circuit Court of Appeals tha...
FDA publishes a guidance clarifying and updating information on using ISO 10993-1 in preparing medical device submissions to FDA.
A bipartisan group of three House members asks CDER to remove the simultaneous marketing provision from a proposed rule on Rx to OTC drug switches.
