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October 3, 2022
Published by Med Search on October 3, 2022
Categories
On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA). This new law includes the reauthorization of the Prescription […]
October 3, 2022
Published by Med Search on October 3, 2022
Categories
Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter[1], FDA is creating the Split Real Time Application Review (STAR) pilot program. Overview FDA […]
October 3, 2022
Published by Med Search on October 3, 2022
Categories
Afinitor (everolimus) Afinitor Disperz (everolimus) Rapamune (sirolimus) Zortress (everolimus) Drug interaction FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Jemperli (dostarlimab-gxly) Keytruda […]
October 1, 2022
Published by Med Search on October 1, 2022
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FDA is committed to enhancing the U.S. drug safety system and envisions the Sentinel System will strengthen FDA’s post-market surveillance capabilities. To support this effort, FDA […]
September 30, 2022
Published by Med Search on September 30, 2022
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On September 30, 2022, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho Oncology, Inc.) for adult patients with previously treated, unresectable, locally […]
September 30, 2022
Published by Med Search on September 30, 2022
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Image By: Robert M. Califf, M.D., Commissioner of Food and Drugs Overdose prevention, reduction in opioid and other substance use disorders (SUD), and effective treatment and […]
September 30, 2022
Published by Med Search on September 30, 2022
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Coronavirus Disease (COVID-19): The FDA continues to take steps to monitor the supply chain. The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and […]
September 30, 2022
Published by Med Search on September 30, 2022
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Bringing more drug competition to the market and addressing the high cost of medicines is a top priority of the Administration, the Department of Health and […]
September 30, 2022
Published by Med Search on September 30, 2022
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Section 3011 of the 21st Century Cures Act established section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), on qualification of drug development […]
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