Federal Register notice: FDA makes available a final guidance entitled #265 Use of Data from Foreign Investigational Studies to Support Effectiveness ...
Cassava Sciences says it is opening its first of two Phase 3 efficacy studies of simufilam for use in patients with mild to moderate Alzheimers diseas...
Fagere Drinker consultants analyze a new FDA draft guidance on how the agency handles benefit/risk assessment for drug and biological products.
FDA accepts for review an Acer Therapeutics NDA for Acer-001 sodium phenylbutyrate) for treating patients with urea cycle disorders.
FDA announces a 10/21-10/22 virtual workshop on fetal pharmacology and therapeutics.
FDA publishes an International Council on Harmonization addendum expanding testing methods for human carcinogenicity risk studies.
FDA warns The Medicine Shoppe in Port Charlotte, FL, that it is producing compounded drugs that dont meet legal requirements and dont comply with CGMP...
FDA medical reviewers raise issues with two trials of Takedas maribavir to treat cytomegalovirus.