FDA Moves to Curb Drug Shortages
FDA Moves to Curb Drug Shortages
As required by the FDA Safety & Innovation Act (FDASIA) of 2012, FDA issued a Strategic Plan for responding to drug shortages Oct. 31, 2013, plus a proposed rule for how manufacturers should notify the agency of an interruption or discontinuation in production of a medically important therapy. The rule expands notification to a broader spectrum of drugs, including biologics, and advises on dealing with suppliers and contract manufacturers.
The Strategic Plan spells out how FDA can better respond to shortage situations and how manufacturers should avoid supply problems: build up inventories before making production changes, improve communications with contract manufacturers, and consider upgrades for aging facilities. There is support for incentives to companies that adopt manufacturing quality improvements and risk-based approaches, but few specifics on rewards for doing so.
Market Demands and Emerging Technologies Shape Outsourcing Models
June 5th 2025Trends in certain forms of drug delivery, as well as the emergence of artificial intelligence, are playing roles in evolving the nature of partnerships, but there are new types of partnerships gaining steam as well.
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.
