USA – Study: Certain cancer drugs saw widespread use before accelerated approval withdrawal
In the period between when three accelerated approval (AA) drugs received approval from the US Food and Drug Administration (FDA) for oncology indications and...
USA – Legal expert: FDA inspections will start looking at DSCSA compliance
Pharmaceutical manufacturers and their trading partners should ensure their distribution systems fully adhere to the Drug Supply Chain Security Act (DSCSA), as once the law takes...
USA – FDA Authorizes First Over-the-Counter At-Home Test to Detect Both Influenza and COVID-19...
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can differentiate and detect...
