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Sharan Murugan
- Jun 8, 2023
- 1 min
USFDA Guidance: Clinical Drug Interaction Studies With Combined Oral Contraceptives
A final industry guidance, "Clinical Drug Interactions Studies with Combined Oral Contraceptives", was released by the United States Food...
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Sharan Murugan
- Jun 6, 2023
- 1 min
USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials
The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good...
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Sharan Murugan
- Jun 5, 2023
- 1 min
USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions
The United States Food & Drug Administration published the final guidance "Cover Letter Attachments for Controlled Correspondences and...
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Sharan Murugan
- Jun 4, 2023
- 2 min
USFDA Guidance: Drug-Drug Interaction Assessment & Nonclinical Evaluation of Immunotoxicity
Last week (02 June 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research, Center for Drug...
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Sharan Murugan
- Jun 4, 2023
- 1 min
USFDA Guidance: Medical Device Submissions "The Q-Submission Program"
Last Friday (02 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health and Center for...
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