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 with questions and answers on applying human factors engineering principles in developing combination drug products.
Four stakeholder groups suggest revisions to an FDA publication of the ICH E6(R3) good clinical practice guideline.
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.
Philips Respironics announces it has set aside $615 million under an agreement to resolve all economic loss claims in a class action lawsuit related t...
FDA releases a draft guidance entitled Endogenous Cushings Syndrome: Developing Drugs for Treatment.
