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Clinical Pharmacology

Pharmacy

Seminar

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

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. Pharmacodynamic (PD) alternatives: Another internal project, this time from CDER’s Office of Clinical Pharmacology (OCP), was presented by YOW-MING WANG, associate director.

Science

Science Biosimilars FDA Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA

FDA Science Regulations Production

Webinars

Bridging Innovation & Patient Care: The Growing Role of AI

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Drug Discovery Digest

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Webinars

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