2027, Clinical Pharmacology and Research

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2027

Clinical Pharmacology

Research

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

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

Science

Science Biosimilars FDA Production

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

CDER, CBER 9/30/2027 Revised or final guidance to be released 18 months after the public comment period ends PDUFA Commitment Letter Digital Health Technologies Publish draft guidance describing a process to evaluate a predetermined change control plan for digital health devices. primary and secondary).

FDA

FDA Science Biosimilars Production

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 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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