FDA Hands Out Million-Dollar Fast-Pass for Drug Approvals
Published Date: 1/10/2025
Notice
Summary
The FDA just gave a special priority review voucher to Neurocrine Biosciences for their rare pediatric disease drug, CRENESSITY (crinecerfont), approved in December 2024. This voucher speeds up future drug reviews, helping get important medicines to kids faster. It’s a big win for patients with rare diseases and could save time and money in drug development.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
FDA Approves CRENESSITY for CAH
CRENESSITY (crinecerfont) was approved on December 13, 2024 as an FDA-approved treatment for glucocorticoid replacement to control androgens in adults and pediatric patients 4 years of age and older with classic congenital adrenal hyperplasia. If you or a child you care for has this condition, there is now an FDA‑approved medicine with that indication.
Priority Review Voucher Issued to Sponsor
The FDA issued a Rare Pediatric Disease Priority Review Voucher to Neurocrine Biosciences for CRENESSITY (crinecerfont) under section 529 of the FD&C Act. The notice states the voucher was awarded following the drug's approval on December 13, 2024 and that FDA is publishing the award.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Related Federal Register Documents
2026-19822, Agency Information Collection Activities; Submission for OMB Review; Comment Request; Access to Employee Exposure and Medical Records
The Department of Labor wants your thoughts on how they collect and share workers’ exposure and medical records to keep employees safe from harmful chemicals and conditions. Employers must keep these records and let workers see them. Comments are open until October 29, 2026, and this review helps make sure the process is clear, useful, and not too much work or cost for anyone.
2026-19928, Indian Gaming; Approval by Operation of Law of the Squaxin Island Tribe and State of Washington Gaming Compact
The Squaxin Island Tribe and Washington State have a new gaming agreement that’s now officially approved by law as of September 29, 2026. This means the tribe can run certain casino games on their land under updated rules, with no extra delays or costs from the government. It’s a win-win for the tribe and the state, keeping gaming fun and fair!
2026-19829, Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice of Law Enforcement Officer's Injury or Occupational Disease and Notice of Law Enforcement Officer's Death
The Department of Labor is asking for public feedback on forms used by non-Federal law enforcement officers to report injuries, illnesses, or deaths related to their jobs. These forms help officers and their families get the benefits they deserve under federal law. Comments on this info collection are open until October 29, 2026, with no new costs or big changes planned.
2026-19826, Agency Information Collection Activities; Submission for OMB Review; Comment Request; Formaldehyde Standard
The Department of Labor wants your thoughts on rules that help protect workers from formaldehyde exposure. Employers must track and share exposure info and offer medical check-ups. Comments are open until October 29, 2026, and this helps keep workplaces safe without adding too much paperwork or cost.
2026-19823, Agency Information Collection Activities; Submission for OMB Review; Comment Request; Crawler, Locomotive, and Truck Cranes Standard
The Department of Labor wants your thoughts on rules for inspecting big cranes and their ropes every month to keep workers safe. If you own or work with crawler, locomotive, or truck cranes, these inspections and records affect you. Comments are open until October 29, 2026, and the goal is to make sure the paperwork is useful without being a hassle or costing too much.
2026-19830, Agency Information Collection Activities; Submission for OMB Review; Comment Request; Survivor's Form for Benefits Under the Black Lung Benefits Act
The Department of Labor is asking for public feedback on a form survivors use to claim benefits under the Black Lung Benefits Act. This form helps decide if survivors can get or keep their benefits. Comments are open until October 29, 2026, and the goal is to make the form easier and less time-consuming without adding costs.
Previous / Next Documents
Previous: 2025-00338, Proposed Collection; Comment Request; Extension: Form 12b-25-Notification of Late filing
The SEC wants to keep using Form 12b-25, which lets companies tell the SEC if they can’t file reports on time and get an automatic extension. About 2,849 companies use this form yearly, spending around 2.5 hours each. The SEC is asking for comments by March 11, 2025, to make sure the form works well and isn’t too much work for companies.
Next: 2025-00341, Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor)
The FDA just gave the green light to ALYFTREK, a new medicine for rare childhood diseases, using a special priority review voucher that speeds up approval. This means kids with rare conditions can get access to this treatment faster, and drug makers get rewarded for developing these important medicines. The approval happened on December 20, 2024, marking a big win for patients and innovators alike!