Federal Register notice: FDA makes available a draft guidance entitled Over-the-Counter Monograph Order Requests (OMORs): Format and Content.
Federal Register notice: FDA announces a request for information and comments on the development of an FDA data and technology strategic plan.
FDA medical reviewers ask two advisory committees to consider whether there is a population of Alzheimers patients for whom Otsuka and Lundbecks Rexul...
The Texas House approves a bill to establish a state program that would allow the importation of some drugs from Canada.
Federal Register notice: FDA makes available a final guidance entitled A Risk- Based Approach to Monitoring of Clinical Investigations Questions and ...
Federal Register notice: CDRH announces its Radiation Sterilization Master File Pilot Program, a voluntary program for companies that terminally steri...
FDA publishes a draft guidance recommending the content and format for submitting OTC monograph order requests to the agency.
Federal Register notice: FDA plans a 6/8 public meeting entitled Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimil...
