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December 21, 2023
The final guidance document provides recommendations for designing a new registry or using an existing registry to support decisions regarding safety and effectiveness of a drug.
The agencies published a joint guidance document regarding quality development for breakthrough therapies and PRIME programs.
December 18, 2023
The Multi-annual AI Workplan creates a strategy to maximize the benefits and manage the risks of artificial intelligence.
December 15, 2023
The guidance document discusses the impact of clinical pharmacology considerations on peptide drug development.
The US District Court for the District of Massachusetts entered a consent decree of permanent injunction against Pharmasol Corporation for distributing adulterated drugs.
December 14, 2023
RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.
December 13, 2023
The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.
Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.
December 11, 2023
The agency released two guidance documents on the interim policy on compounding using bulk drug substances for both outsourcing and non-outsourcing facilities.
December 02, 2023
FDA and industry face unprecedented political and policy challenges.