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October 26, 2022
An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.
October 12, 2022
CBER maps modernization plan to handle surge in research and applications.
September 30, 2022
FDA has approved Relyrio as a once-to-twice daily treatment for patients with ALS.
September 23, 2022
Legislative leaders are looking to approve a bare-bones measure to fund FDA operations as part of a short-term government funding bill.
September 07, 2022
The patent applications are for programs concerning lupus, idiopathic pulmonary fibrosis, and chronic kidney disease.
A Post Approval Change (PAC) to replace identity (ID) testing of incoming liquid drug substance with ID by visual inspection is considered a low risk provided questioned listed in this example have been answered favorably. In that case the PAC can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.
September 02, 2022
Change of lot or extension of reference standard shelf-life is considered low risk and should be downgraded from prior-approval to being managed in the Pharmaceutical Quality System (PQS) only based on a science and risk-based approach.
September 01, 2022
A Post Approval Change (PAC) in size of thermal shipping solution used for transport of product is considered a low risk provided it has been qualified and temperature monitored, and therefore can be downgraded from a prior approval to a notification to health authorities, and managed in the PQS with immediate implementation effect.
August 30, 2022
Novavax’s COVID-19 vaccine, Nuvaxovid, can now be given to adolescents aged 12 to 17 in the UK.
August 29, 2022
The European Union publishes long-awaited changes to Annex 1.