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FDA releases a draft guidance entitled Endogenous Cushings Syndrome: Developing Drugs for Treatment.
Janssen Pharmaceutical discontines, due to futility, its Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with chronic thromboembolic pu...
CymaBay Therapeutics says it will seek FDA approval for seladelpar for treating adult patients with primary biliary cholangitis after reporting Phase ...
Federal Register notices: FDA issues two priority review vouchers to sponsors whose recent product approvals met the criteria (rare pediatric disease ...
