The Pharma Data

NOVEMBER 9, 2020

On August 20, 2018, the Company signed the Exclusive Dealing Agreement with Prof. “Our initial focus is to develop standardized drug formulations with precise, predictable and efficient API delivery for clinical study and therapeutic use.” ” Prof.

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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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Agency IQ

OCTOBER 20, 2023

.” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. For example, in 2018 the FDA published an extensive draft Q&A guidance document that answered 12 questions related to biosimilar or interchangeable products.

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