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![USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products](https://static.wixstatic.com/media/nsplsh_4a32384e6e2d4344624949~mv2_d_3000_3000_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_4a32384e6e2d4344624949~mv2_d_3000_3000_s_4_2.jpg)
Sharan Murugan
- Sep 11, 2023
- 2 min
USFDA Guidance: IRB Review of Individual Patient Expanded Access Submissions & Peptide Drug Products
Earlier today (11 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for...
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![USFDA Guidance: Premarket Notification [510(k)] Submissions](https://static.wixstatic.com/media/nsplsh_453363554d4e4263424363~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_453363554d4e4263424363~mv2.jpg)
Sharan Murugan
- Sep 10, 2023
- 2 min
USFDA Guidance: Premarket Notification [510(k)] Submissions
The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research...
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![USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information](https://static.wixstatic.com/media/nsplsh_d18c17b5ec374655babcca256f9533a1~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_d18c17b5ec374655babcca256f9533a1~mv2.jpg)
Sharan Murugan
- Sep 10, 2023
- 2 min
USFDA Guidance: Post-Warning Letter Meetings & Interoperable Exchange of Information
Recently on 05 September 2023, the United States Food & Drug Administration's Center for Drug Evaluation and , Research, Center for...
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![USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors](https://static.wixstatic.com/media/nsplsh_474a616f335a5458396755~mv2_d_6016_4016_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_474a616f335a5458396755~mv2_d_6016_4016_s_4_2.jpg)
Sharan Murugan
- Aug 17, 2023
- 1 min
USFDA Guidance: Informed Consent Guidance for IRBs, Clinical Investigators, & Sponsors
The U.S. Food and Drug Administration (FDA) released its final guidance this Tuesday (15 August 2023), "Informed Consent: Guidelines for...
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![USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products](https://static.wixstatic.com/media/6516fb_5729f12f4b4f448b9de0104f5b49b907~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_5729f12f4b4f448b9de0104f5b49b907~mv2.jpg)
Sharan Murugan
- Aug 10, 2023
- 2 min
USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products
Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...
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