Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

Development 161

Development Production Immune Response Licensing 161

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.” Develop and implement corrective and preventive action plans to resolve issues. By Sarah Wicks & Anne K. Provide a method of verifying or monitoring the effectiveness of the actions.

Compliance 111

Compliance Bioequivalency Cosmetics Regulation 111

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.

Production 78

Production Insulin Branding Generic Drugs 78