FDA Law Blog
JUNE 10, 2024
Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” By Sarah Wicks & Anne K. Ensure all relevant records and data (whether electronic or otherwise) are readily accessible and organized for review.
Camargo
DECEMBER 13, 2021
Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. BLA process (CBER).
XTalks
FEBRUARY 8, 2021
While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.
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