FDA expedited drug approval plan
Executive Summary
Agency will probably issue its plan for treatments of life-threatening diseases as a guideline, rather than a regulation, to avoid the notice-and-comment rulemaking procedures for regs. FDA is hoping the Presidential Task Force on Regulatory Relief, which requested the proposal ("The Pink Sheet" Aug. 29, p. 8), will finish its review the week of Sept. 5. FDA Commissioner Young has completed his outside briefings on the issue. He met the week of Aug. 29 with medical health professionals and government agencies that would be affected by the action. The proposal has generally been supported by those who have met with Young, although consumer and AIDS groups are reserving their final judgment until publication.You may also be interested in...
Rare Disease Advocates Lobby US Congress For FDA Center of Excellence
Number one ask is for congressional pressure to centralize rare disease expertise at the agency, but advocates also are preparing legislation that would mandate the new center.
FDA’s 2021 Budget Priorities For Cosmetics, Food Programs Include AI Use In Postmarket Oversight
FDA’s food, dietary supplement and cosmetics division seeks funding to support its artificial intelligence capabilities, including post-market surveillance and speedy interventions in instances where safety issues arise. Also of note, the agency cites UV filters’ effects on the skin microbiome as a research priority in its fiscal 2021 budget justification to Congress.
Don't Take For Granted A Patient's Role In Clinical Trials, Experts Say
Catering to patients can help make clinical trials more accessible and useful, presenters argued at a recent conference.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: