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FDA has recently increased its efforts to support the development and approval of cell, tissue, and gene therapy (CTGT) products. This is evidenced by the upswing in CTGT approvals in...
These Are The Top Priorities & Challenges For New CDER Director Patrizia Cavazzoni, M.D. By Lowell M. Zeta and Lynn Mehler, Hogan Lovells Scientific breakthroughs have revolutionized the development of new and more personalized therapies to address unmet medical needs through enhanced technologies and data-informed capabilities. Advances in data infrastructure, clinical trial design, and other medical product technologies and the 21st Century Cures Act and other legislation aim to bring new innovations to patients who need them faster. These developments are requiring the FDA to rethink the w...
POLITICO Get the Prescription Pulse newsletter Email Sign Up By signing up you agree to receive email newsletters or updates from POLITICO and you agree to our privacy policy and terms of service. You can unsubscribe at any time and you can contact us here. This sign-up form is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Presented by Pharmaceutical Care Management Association With Lauren Morello and Sarah Owermohle. On Tap — U.S. is now sequencing six percent of Covid-19 cases. — FDA rebuts Trump-era proposal to deregulate review of many medical device...