The Final Q-Sub Guidance provides comprehensive guidance on the Q-Sub process and finalizes the draft guidance regarding the Q-Sub program that was issued on March 15, 2024, with minimal changes from ...
On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new ...
The Food and Drug Administration’s science-based mission includes receiving, generating and reviewing a wealth of data and products from the vast array of manufacturers and firms that the agency ...
CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...
Chris is the CTO and Co-Founder of Scientist.com, a Research Platform helping drug discovery researchers develop new therapies. The FDA’s adoption of electronic submissions raised concerns about data ...
Biogen (NASDAQ:BIIB) and Eisai (OTCPK:ESAIY) announced the rolling submission of a marketing application to receive an FDA label expansion for a subcutaneous autoinjector that delivers their Alzheimer ...
Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...
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