Sunday, July 19, 2020 9:33:22 AM
The FDA review team has 30 days to review the original IND submission. The process protects volunteers who participate in clinical trials from unreasonable and significant risk in clinical trials. FDA responds to IND applications in one of two ways:
Approval to begin clinical trials.
Clinical hold to delay or stop the investigation. FDA can place a clinical hold for specific reasons, including:
Participants are exposed to unreasonable or significant risk.
Investigators are not qualified.
Materials for the volunteer participants are misleading.
The IND application does not include enough information about the trial’s risks.
A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the applicant is allowed to proceed with the proposed study.
Recent JSDA News
- Form 8-K - Current report • Edgar (US Regulatory) • 05/30/2024 08:00:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/23/2024 06:21:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/17/2024 08:18:12 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 07:46:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/14/2024 08:10:16 PM
- Form 3/A - Initial statement of beneficial ownership of securities: [Amend] • Edgar (US Regulatory) • 12/27/2023 11:12:17 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/21/2023 12:39:11 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 12/05/2023 02:50:11 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2023 07:46:03 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/09/2023 09:10:14 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/22/2023 10:13:32 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/11/2023 08:02:40 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/09/2023 08:10:51 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/18/2023 08:04:25 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 07/11/2023 12:02:11 AM
Glidelogic Corp. Becomes TikTok Shop Partner, Opening a New Chapter in E-commerce Services • GDLG • Jul 5, 2024 7:09 AM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM