Tag: FDA regulations
Skinny Labeling: Impact of GSK v. Teva on Regulatory Compliance and Generics Market
Congress enacted the Hatch-Waxman Act to strike a balance between promoting generic competition and encouraging pharmaceutical innovation. The Act requires innovators to disclose patents to the FDA for listing in the Orange Book, while...
FDA Center for Clinical Trial Innovation: Improving Trial Processes and Patient Safety
In April 2024, the U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER) introduced the Center for Clinical Trial Innovation (C3TI) to enhance communication and collaboration in clinical trials. C3TI aims...
Supreme Court Upholds Abortion Drug Access, Challengers Lack Standing Abortion Drug Access Secured by Supreme...
The U.S. Supreme Court recently made a unanimous decision regarding expanded access to the abortion drug mifepristone. The ruling stated that anti-abortion medical groups and doctors who challenged this access lacked standing to sue....