USA – FDA warns pharmacy benefit company for distributing unapproved foreign drugs
The US Food and Drug Administration (FDA) recently warned pharmacy benefit firm ElectRx for substituting prescription drugs ordered by its customers with drugs sourced...
USA – FDA approves first treatment for Rett Syndrome
FDA has approved Daybue (trofinetide) oral solution as the first treatment for Rett syndrome, a rare, genetic neurological disorder. Daybue is approved for the...
USA – Pfizer: le spray nasal anti-migraine approuvé par la FDA
Pfizer a annoncé vendredi que la Food and Drug Administration (FDA) américaine avait approuvé le Zavzpret, son spray nasal pour le traitement de la...
USA – Generic drugmakers seek clarity on pre-submission facility correspondence
Drugmakers want clarifications on an updated draft guidance the US Food and Drug Administration (FDA) recently released on pre-submission facility correspondence (PFC) for generic...
USA – FDA seeks feedback on artificial intelligence in drug manufacturing
The US Food and Drug Administration (FDA) is soliciting feedback on how to incorporate artificial intelligence (AI) and advanced manufacturing techniques into the current...
USA – FDA issues guidance on drug development for neovascular age-related AMD
The US Food and Drug Administration (FDA) has issued draft guidance for industry on the development of drugs to treat neovascular or “wet” age-related...
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...
USA – HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules
The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year....
