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![USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model](https://static.wixstatic.com/media/nsplsh_5a3366585075786131356b~mv2_d_4032_3024_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_5a3366585075786131356b~mv2_d_4032_3024_s_4_2.jpg)
Sharan Murugan
- Nov 19, 2023
- 2 min
USFDA MD Guidance: Notifying FDA of a Permanent Discontinuance, 506J Guidance & Computational Model
USFDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple guidances related...
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![USFDA Guidance: Real-Time Oncology Review (RTOR)](https://static.wixstatic.com/media/nsplsh_4c6e764345585177432d6f~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_4c6e764345585177432d6f~mv2.jpg)
Sharan Murugan
- Nov 11, 2023
- 2 min
USFDA Guidance: Real-Time Oncology Review (RTOR)
The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) released guidance earlier this week (07 November 2023)...
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![USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation](https://static.wixstatic.com/media/nsplsh_71777443654a35634c5973~mv2_d_2947_2121_s_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_71777443654a35634c5973~mv2_d_2947_2121_s_2.jpg)
Sharan Murugan
- Nov 6, 2023
- 2 min
USFDA Guidance: Submitting Patient-Reported Outcome Data, Clinical Trial Datasets & Documentation
Today (06 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) released two final...
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![USFDA MD Guidance: Enforcement Policy for Clinical Electronic Thermometers](https://static.wixstatic.com/media/nsplsh_a56d2c1ddac543ec9a0c438d234245e8~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_a56d2c1ddac543ec9a0c438d234245e8~mv2.jpg)
Sharan Murugan
- Nov 5, 2023
- 1 min
USFDA MD Guidance: Enforcement Policy for Clinical Electronic Thermometers
Last Friday (03 November 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Enforcement Policy for Clinical...
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![USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption](https://static.wixstatic.com/media/nsplsh_746146336b6c7777415741~mv2_d_5955_3970_s_4_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_746146336b6c7777415741~mv2_d_5955_3970_s_4_2.jpg)
Sharan Murugan
- Nov 2, 2023
- 1 min
USFDA Guidance: Supplements for Approved Premarket Approval or Humanitarian Device Exemption
Today (02 November, 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...
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