FDA expedited drug approval plan
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...
Data presented at AAAI meeting show reduced annualized asthma exacerbation rates across all patient populations, but doctors are unlikely to switch patients served well by existing biologics.
The RNA drug’s accelerated approval brings Sarepta’s exon-skipping market share to nearly 30%.
Limiting interactions to two-dimensional settings will hinder collaboration, innovation and the mentoring of younger employees, Merck & Co. CEO Kenneth Frazier says. Frazier, who will retire in June, is looking forward to returning to public service but says "politics with a capital P is not my thing."