Regulatory Roundup: USP Expands Presence in India
USP Expands Presence in India.
The US Pharmacopeia (USP) opened last week a newly expanded state-of-the-art facility in the IKP Knowledge Park of Hyderabad, India. The facility expands USP’s presence in the area from 14,000 square feet to more than 100,000 square feet. An additional 20 employees, from the base number of 70, will be added throughout the coming year.
Former FDA Commissioner Dr. Charles Edwards has passed away. During his tenure, "Dr. Edwards was one of the country’s most ardent drug safety advocates, ordering the extensive review of over-the-counter drugs for safety, effectiveness, and accuracy in labeling," wrote current Commissioner Margaret Hamburg in a letter on the FDA website. Dr. Edwards led FDA from December 1969 to March 1973, during which time he steered the agency towards a greater regulatory role and helped to double the agency’s budget.
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.
