by Katrina Rogers | Jun 27, 2023 | Medical Products, Product Development
Introduction The FDA issued final guidance on the qualification process for Drug Development Tools (DDTS) in November 2020 after one round of revision and comments on the original draft published in 2014. With this document, titled “Qualification Process for...
by Katrina Rogers | Jun 20, 2023 | Medical Products, Product Development
Rapid and secure communication with the FDA is an essential task within the regulated industry, and CDER makes some communications easier through the NextGen Collaboration portal. This tool is part of the FDA’s efforts to streamline and modernize the drug...
by Katrina Rogers | May 11, 2023 | Business, Leadership
SBIR/STTR grants are valuable resources for startup founders and researchers looking to fund their research and development efforts and turn their innovative ideas into successful startups. The SBIR/STTR program, which stands for Small Business Innovation Research and...
by Katrina Rogers | Apr 25, 2023 | Ecosystem Development
The Impact of the FDA Modernization Act 2.0 Late in December 2022, President Biden signed H.R. 2617 (117th): Consolidated Appropriations Act into law. While boringly titled, this Act contained the FDA Modernization Act 2.0, proposed initially as S.5002. While this...
by Katrina Rogers | Apr 25, 2023 | Medical Products, Medicine, Science
The FDA’s thinking on Digital Health Technologies (DHT) continues to evolve. They released the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development in March. This publication, a PDUFA VII commitment, will “guide activities...
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