Agency IQ

MARCH 1, 2024

Government shutdown: At present, the FDA has appropriated funding lasting until midnight on Friday, March 1. Given that the rule is currently under White House review, we’re expecting this to soon be released. The following PDUFA dates were obtained from publicly available sources.

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FDA Science Clinical Trials Regulations 40

Agency IQ

FEBRUARY 2, 2024

Government shutdown: At present, the FDA has appropriated funding March 1. QMSR final rule : For years, the FDA has been talking about harmonizing its Quality System Regulation with ISO 13485:2016, which it would incorporate by reference. The following PDUFA dates were obtained from publicly available sources.

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FDA Science Clinical Trials Regulations 40

Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). As a reminder, the U.S.

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FDA Biosimilars Science Production 52

Agency IQ

SEPTEMBER 29, 2023

What we expect to be talking about in October: Government shutdown: The odds of a government shutdown happening in October are, we think, rather high absent a last-minute breakthrough in Congressional negotiations. Of note: A government shutdown would likely delay or cancel some of the events listed below.

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FDA Science Regulations Production 40

The Pharma Data

OCTOBER 15, 2020

Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics. Shashank joins Trevi from Metrum Research Group where he was senior principal scientist for Clinical Pharmacology. Floyd co-founded Elion Oncology which licensed PCS6422 to Processa.

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Pharmaceuticals Clinical Pharmacology Medical Schools Vaccine 52