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FDA Launches Pilot Program to Shorten Drug Approval Times
Confirmed
In Short: The Food and Drug Administration (FDA) has announced a pilot program aimed at accelerating the initial testing phase for new drugs, as part of its broader initiative to compete with global biotech leaders.
The FDA is opening applications for a pilot program designed to shorten the amount of time it takes for drugmakers to begin testing their products in humans, the agency announced Tuesday.
This initiative is part of Operation TrialBlazer, a Department of Health and Human Services effort to reduce drug approval timelines and enhance the U.S.'s competitiveness in the biotech industry.
Scholar Rock received FDA approval for Isembyld, the first therapy targeting the loss of muscle in spinal muscular atrophy, raising hopes for improved mobility for patients.
What's confirmed
- The FDA is opening applications for a pilot program designed to shorten the amount of time it takes for drugmakers to begin testing their products in humans, the agency announced Tuesday.
- This initiative is part of Operation TrialBlazer, a Department of Health and Human Services effort to reduce drug approval timelines and enhance the U.S.'s competitiveness in the biotech industry.
- Scholar Rock received FDA approval for Isembyld, the first therapy targeting the loss of muscle in spinal muscular atrophy, raising hopes for improved mobility for patients.
What's still developing
- Test your knowledge with our new weekday mini crossword Margaret is a Washington correspondent covering the Food and Drug Administration and other federal health agencies.
- Apple is preparing for one of its most important product launches in years, with the company's September 9 event expected to introduce a new generation of premium iPhones, Apple Watches and, potentially, a completely new product category for the company: a foldable iPhone.
- Cognizant has about 3,510 H-1B approvals as of 30 June, according to USCIS data.
- The suspension applies to PERM, or Program Electronic Review Management, the labour-certification process through which US employers seek approval to sponsor foreign workers for permanent residency.
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- A late-stage clinical trial found that, when combined with an SMN2-targeting drug, Isembyld caused young patients’ motor skills to improve after a year, while those in a placebo group declined, a difference that was statistically significant.
- “Today’s FDA approval of Isembyld marks a defining moment for the SMA community,” said David Hallal, CEO of Scholar Rock, in a press release.
- The FDA approved the drug, Isembyld, for use in adults and children 2 years and older who are currently receiving SMA therapies that target SMN2, a key gene for neurons that control movement.