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![USFDA Guidance: Identification of Medicinal Products — Implementation and Use](https://static.wixstatic.com/media/nsplsh_0ba9bd70ab8843d7901413fb572597eb~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_0ba9bd70ab8843d7901413fb572597eb~mv2.jpg)
Sharan Murugan
- Mar 31, 2023
- 1 min
USFDA Guidance: Identification of Medicinal Products — Implementation and Use
Today (31 March 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released updated...
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![USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device](https://static.wixstatic.com/media/nsplsh_7431506149624d544a494d~mv2_d_3648_2048_s_2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_7431506149624d544a494d~mv2_d_3648_2048_s_2.jpg)
Sharan Murugan
- Mar 30, 2023
- 1 min
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...
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![USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems](https://static.wixstatic.com/media/nsplsh_bc055122f7234677b97671d06d41ff6d~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_bc055122f7234677b97671d06d41ff6d~mv2.jpg)
Sharan Murugan
- Mar 30, 2023
- 2 min
USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems
Earlier today (30 March 2023) USFDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research...
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![USFDA Update: In-Person, Face-to-Face ANDA Program Meetings](https://static.wixstatic.com/media/nsplsh_17393fc587d04dbdb0071c7db107a505~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_17393fc587d04dbdb0071c7db107a505~mv2.jpg)
Sharan Murugan
- Mar 28, 2023
- 1 min
USFDA Update: In-Person, Face-to-Face ANDA Program Meetings
Starting from March 27, 2023, the FDA generic drug program will resume in-person face-to-face (FTF) meetings with the industry along with...
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![USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices](https://static.wixstatic.com/media/nsplsh_8278680c4c7c4322817d946f3823011d~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_8278680c4c7c4322817d946f3823011d~mv2.jpg)
Sharan Murugan
- Mar 27, 2023
- 2 min
USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices
Today (27 March 2023) USFDA's Center for Devices and Radiological Health released final guidance on "General Considerations for Animal...
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