The biopharma industry is poised for significant transformation in the coming years, with several critical FDA decisions expected in the near future. These decisions will not only impact individual companies and products but have far-reaching implications for the entire industry— shaping market dynamics, investment strategies and the trajectory of innovation. As industry leaders navigate this complex landscape, they must remain vigilant of FDA’s actions and adapt their strategies to capitalize on emerging opportunities while mitigating potential risks.
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Recent Blogs
MoCRA Submission Encouraged by Dec. 29, 2023; Enforcement Delayed
On November 8, 2023, the Food and Drug Administration (FDA) announced that it will be ready to accept registration and listing information for the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by the statutory deadline of December 29, 2023 and encourages companies to meet that deadline.
FDA Releases MoCRA Draft Guidance
On August 7, 2023, the Food and Drug Administration (FDA) released draft guidance providing recommendations and instructions pertaining to the collection and submission of information related to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), specifically, to assist persons submitting cosmetic product facility registrations and product listings to FDA.
Combination Products: Regulatory Requirements and How To Comply
Continue to be at the forefront of regulatory chatter. Our customers, both primarily medical device and primarily pharmaceutical, are regularly coming to us with questions surrounding this topic. Reed Tech answers these questions here in this blog post
Ensure Imports are Not Detained Due to FDA Non-Compliance
In the final webinar of 2020, Reed Tech invited an expert attorney to discuss import compliance and how it ties into FDA compliance. David Wilson, Reed Tech, and Jennifer Diaz, Esq., Diaz Trade Law, discussed many topics ranging from compliant importation and FDA...