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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

Other comments from the American College of Clinical Pharmacy (ACCP) and American Association of Colleges of Pharmacy (AACP) also endorsed the actions sought in the Citizen Petition. FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine.

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Science FDA Clinical Trials Pharmacy 40
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Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

DECEMBER 11, 2023

For example, FDA’s Project Renewal was announced in 2021 as a concerted effort to update labeling information for “older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.” In 2021, FDA’s efforts on dose optimization came to the forefront with the announcement of Product Optimus.

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FDA Science Clinical Trials Trials 40
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