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Four stakeholder groups suggest revisions to an FDA publication of the ICH E6(R3) good clinical practice guideline.[ Price : $8.95]
FDA publishes a guidance clarifying and updating information on using ISO 10993-1 in preparing medical device submissions to FDA.[ Price : $8.95]
A bipartisan group of three House members asks CDER to remove the simultaneous marketing provision from a proposed rule on Rx to O...[ Price : $8.95]
Philips Respironics announces it has set aside $615 million under an agreement to resolve all economic loss claims in a class acti...[ Price : $8.95]
FDA releases a draft guidance entitled Endogenous Cushings Syndrome: Developing Drugs for Treatment.[ Price : $8.95]
Janssen Pharmaceutical discontines, due to futility, its Phase 3 MACiTEPH study evaluating macitentan 75 mg in patients with chron...[ Price : $8.95]
CymaBay Therapeutics says it will seek FDA approval for seladelpar for treating adult patients with primary biliary cholangitis af...[ Price : $8.95]
Federal Register notices: FDA issues two priority review vouchers to sponsors whose recent product approvals met the criteria (rar...