FDA announces CMC review pilot for drugs with expedited development The US Food and Drug Administration (FDA) announced on 31 October a limited chemistry, manufacturing and controls (CMC) development ...

Officials from the US Food and Drug Administration (FDA) and representatives from the pharmaceutical industry shared insights on the agency’s Chemistry, Manufacturing, and Controls (CMC) Development ...

Developing a new medication can cost over $1 billion, depending on the drug’s complexity and expenses accrued via unsuccessful studies. Considering these costs, an optimized regulatory process is ...

Co-developed with top 10 pharmas, Genedata Vico drives insight and decision-making in CMC, winning Bio-IT World award. From Documents to Data-Driven CMC and Agentic AI Genedata Vico was developed with ...

CAMBRIDGE, England & BOSTON--(BUSINESS WIRE)--Bicycle Therapeutics (Nasdaq: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic ...

SARASOTA, FL, July 18, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and ...

In this interview, News-Med talks to Tammy Newbold about the Global Harmonization of Regulatory CMC within Veterinary Medicine. Can you explain what global harmonization of regulatory CMC entails and ...

As the FDA's May 2026 guidance on AI in drug manufacturing takes effect and a new pilot program offers sponsors extra CMC-focused meetings, the pressure is on to modernize regulatory workflows.

FDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program supports the acceleration of manufacturing readiness for therapies with expedited clinical development ...