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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
November 02, 2022
FDA keeps its user fees but fails to gain important reforms.
New medications show exciting outcomes for weight loss.
October 26, 2022
AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.
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.