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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
October 15, 2021
After months of deliberation, Biden plans to appoint cardiologist Robert Califf as FDA commissioner.
October 02, 2021
A new program will test the safety and suitability of new inactive ingredients to encourage the accelerated adoption of FDA-accepted excipients in drug development.
October 01, 2021
FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.
September 02, 2021
Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?
August 04, 2021
CMA fines Advanz and investors for more than £100 million (approximately US$139 million) after the company increased the price of thyroid tablet packs from £20 (US$23.74) in 2009 to £248 (approximately US$295) in 2017.
August 02, 2021
Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.
July 02, 2021
HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.
June 02, 2021
Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.
May 02, 2021
Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.
March 02, 2021
Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.