2018, Biosimilars and Clinical Pharmacology

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2018

Biosimilars

Clinical Pharmacology

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 FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

This is a significant jump from any previous year, with the former peak at 15 in FY 2018, followed by several years in the 10-14 range. For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules.

FDA

FDA Biosimilars Science 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 FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

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