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Tuesday, December 20, 2022 7:38:31 AM
Zachary Brennan
Senior Editor
Congressional negotiators have decided to include reforms to the FDA’s accelerated approval pathway in its year-end spending package after the agency’s top leaders called for tighter controls on confirmatory trials and an easier process for withdrawing dangling accelerated approvals that failed their confirmatory trials.
The text of the bill, known as the omnibus, had been floated earlier this summer but it was unclear what it might attach to. Now, the AA reforms, released late last night, appear to be ready for showtime, stipulating that moving forward, FDA “may require, as appropriate, a [confirmatory] study or studies to be underway prior to approval, or within a specified time period after the date of approval.”
Recent AVXL News
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/17/2024 11:30:10 AM
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- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 05/17/2024 10:01:00 AM
- Anavex Life Sciences to Present at the H.C. Wainwright 2nd BioConnect Investor Conference at NASDAQ • GlobeNewswire Inc. • 05/14/2024 11:30:00 AM
- Shareholders that lost money on Anavex Life Sciences Corporation(AVXL) Urged to Join Class Action - Contact The Gross Law Firm to Learn More • PR Newswire (US) • 05/10/2024 09:45:00 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/09/2024 08:35:55 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/09/2024 12:00:30 PM
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- Anavex Life Sciences to Announce Fiscal 2024 Second Quarter Financial Results on Thursday, May 9th, 2024 • GlobeNewswire Inc. • 05/02/2024 11:30:00 AM
- May 13, 2024 Deadline: Contact The Gross Law Firm to Join Class Action Suit Against AVXL • PR Newswire (US) • 04/26/2024 09:45:00 AM
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- Anavex Life Sciences to Present at the 23rd Annual Needham Virtual Healthcare Conference • GlobeNewswire Inc. • 03/25/2024 11:30:00 AM
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