Biosimilars, Books and Clinical Pharmacology

Search:

DAY

WEEK

MONTH

YEAR

Select your country:
Sign up | Log in

Biosimilars

Books

Clinical Pharmacology

FDA Releases Draft Labeling Guidance for Biosimilar Products

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

Labelling

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Biosimilars

DECEMBER 6, 2024

However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents. CBERs approach here was to take FAQs from across sponsor interactions, public workshops, email requests, etc.

Documentation

Documentation Packaging Clinical Pharmacology Drug Development

Pharmacist Digest

FDA Releases Draft Labeling Guidance for Biosimilar Products

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

Stay Connected