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December 14, 2022
The objectives of the new opportunity are to improve the quality and/or use of RWD, promote better understanding of RWE study designs, and develop specific tools to evaluate aspects of RWE generation.
September 22, 2022
FDA backs the benefits of adopting continuous manufacturing, a strategy which has accelerated approval and launch timelines, and its Emerging Technology Program could be a helpful tool.
March 15, 2021
Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.
October 15, 2020
Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.
July 30, 2020
EMA's CHMP has adopted a positive opinion for Dapivirine Vaginal Ring for women in non-EU countries where HIV disease burden is high.
July 16, 2020
Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.
April 02, 2020
With ingredients sold to multiple markets, excipient manufacturers must understand the different regulatory requirements for pharma vs. food.
April 01, 2020
Understanding European GMPs and new rules from China for excipients are crucial for formulating solid-dosage drugs.