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FDA briefing documents released Friday morning in advance of Tuesday's Arthritis Advisory Committee Meeting (adcom) suggested the agency will go gentle on the biologics license application for CT-P13, Celltrion Inc.'s biosimilar to Remicade (infliximab, Janssen Biotech Inc.) that is approved elsewhere as Remsima (infliximab).

Delays in putting out much-needed guidance earned the FDA a C+ Thursday in its implementation of the biosimilar path, but the Centers for Medicare & Medicaid Services (CMS) got a D- for not even trying.

HONG KONG – The Korean Ministry of Food and Drug Safety (MFDS) is shortening the biologics review process for rare and incurable diseases to speed up the approvals and overseas distribution of Korea-developed biopharmaceuticals.

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