thought leadership

ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

ANDA FDA

July 25, 2022

FDA publishes two final guidances for industry: Orange Book Questions and Answers; Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

July 2022 As part of FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug...

FDA North America

July 20, 2022

FDA Draft Guidance for Industry, Evaluation of Therapeutic Equivalence

FDA Draft Guidance July, 2022 As part of the FDA’s continued efforts to provide helpful information to regulated industry and the public, the agency has published a draft guidance for industry,...

Inspiring the Future of Drug Development

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.