Monday, May 06, 2024 6:31:18 PM
Certify Initial Approval: Trial studies an FDA-regulated drug product (including a biological product) or device product that was not approved, licensed or cleared by FDA for any use before the Primary Completion Date of the trial, and the sponsor intends to continue with product development and is either seeking, or may at a future date seek, FDA approval, licensure, or clearance of the drug product (including a biological product) or device product under study.
Certify New Use: Trial studies an FDA-regulated drug product (including a biological product) or device product that previously has been approved, licensed, or cleared, for which the manufacturer is the sponsor of the trial and for which an application or premarket notification seeking approval, licensure, or clearance of the use being studied (which is not included in the labeling of the approved, licensed, or cleared drug, product (including a biologic product) or device product) has been filed or will be filed within one year with FDA.
Extension: Request, for good cause, an extension of the deadline for submitting results information.
Could we FOIA this and find out what the delay reason was?
Recent ANIP News
- ANI Pharmaceuticals Announces the FDA Approval and Launch of Ketoconazole Shampoo, 2% • GlobeNewswire Inc. • 09/26/2024 10:50:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/20/2024 08:03:19 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/16/2024 08:50:53 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/16/2024 01:13:56 PM
- ANI Pharmaceuticals, Inc. Completes Acquisition of Alimera Sciences • GlobeNewswire Inc. • 09/16/2024 12:53:27 PM
- ANI Pharmaceuticals Initiates Closing of Acquisition of Alimera Sciences • GlobeNewswire Inc. • 09/16/2024 10:50:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/13/2024 08:23:15 PM
- ANI Pharmaceuticals Launches Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution • GlobeNewswire Inc. • 09/13/2024 10:50:00 AM
- ANI Pharmaceuticals and Alimera Sciences Announce Closing Date of Merger • Business Wire • 09/11/2024 10:50:00 AM
- ANI Pharmaceuticals and Alimera Sciences Announce Closing Date of Merger • GlobeNewswire Inc. • 09/11/2024 10:50:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/10/2024 08:44:38 PM
- ANI Pharmaceuticals Provides Update on Closing of Acquisition of Alimera Sciences • GlobeNewswire Inc. • 09/10/2024 06:09:55 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2024 12:29:49 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 08:21:44 PM
- ANI Pharmaceuticals, Inc. Closes $316.25 Million Convertible Senior Notes Offering Including Full Exercise of Initial Purchasers’ Option to Purchase Additional Notes • GlobeNewswire Inc. • 08/13/2024 08:05:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2024 01:51:52 AM
- ANI Pharmaceuticals, Inc. Prices Upsized $275.0 Million Convertible Senior Notes Offering • GlobeNewswire Inc. • 08/08/2024 01:44:18 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/07/2024 11:26:24 AM
- ANI Pharmaceuticals, Inc. Announces Proposed Convertible Senior Notes Offering • GlobeNewswire Inc. • 08/07/2024 11:00:55 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 10:57:57 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 10:53:07 AM
- ANI Pharmaceuticals Reports Second Quarter 2024 Financial Results and Raises 2024 Guidance • GlobeNewswire Inc. • 08/06/2024 10:50:00 AM
- ANI Pharmaceuticals to Discuss Second Quarter 2024 Financial Results on August 6, 2024, at 8:30 a.m. ET • GlobeNewswire Inc. • 07/31/2024 11:00:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/19/2024 09:30:14 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/19/2024 09:27:27 PM
ZenaTech, Inc. (NASDAQ: ZENA) Launchs IQ Nano Drone for Commercial Indoor Use • HALO • Oct 10, 2024 8:09 AM
CBD Life Sciences Inc. (CBDL) Targets Alibaba as the Next Retail Giant for Wholesale Expansion of Top-Selling CBD Products • CBDL • Oct 10, 2024 8:00 AM
Foremost Lithium Announces Option Agreement with Denison on 10 Uranium Projects Spanning over 330,000 Acres in the Athabasca Basin, Saskatchewan • FAT • Oct 10, 2024 5:51 AM
Element79 Gold Corp. Reports Significant Progress in Community Relations and Development Efforts in Chachas, Peru • ELEM • Oct 9, 2024 10:30 AM
Unitronix Corp Launches Share Buyback Initiative • UTRX • Oct 9, 2024 9:10 AM
BASANITE INDUSTRIES, LLC RECEIVES U.S. PATENT FOR ITS BASAFLEX™ BASALT FIBER COMPOSITE REBAR AND METHOD OF MANUFACTURING • BASA • Oct 9, 2024 7:30 AM