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Sharan Murugan
Sep 11, 20232 min read
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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Sharan Murugan
Sep 10, 20232 min read
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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Sharan Murugan
Sep 10, 20232 min read
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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Sharan Murugan
Aug 17, 20231 min read
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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Sharan Murugan
Aug 10, 20232 min read
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Today (11 August 2023) the United States Food & Drug Administration released a draft guidance “Formal Meetings Between the FDA and...
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Sharan Murugan
Aug 10, 20232 min read
USFDA Guidance: QTc Information in Prescription Drug & Biological Product Labeling
Recently on 08 August 2023, the United States Food & Drug Administration's Oncology Center of Excellence, Center for Drug Evaluation and...
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Sharan Murugan
Aug 4, 20232 min read
USFDA Guidance: Recommended Acceptable Intake Limits for Nitrosamine DS-Related Impurities
Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
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Sharan Murugan
Aug 4, 20232 min read
USFDA Guidance: Waivers, Exceptions, & Exemptions from Section 582 of FD&C Act
Today (04 August 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
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Sharan Murugan
Aug 1, 20232 min read
USFDA Guidance: Assessing User Fees -BsUFA III: Biosimilar User Fee Amendments of 2022
Today (31 July 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...
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Sharan Murugan
Jul 30, 20232 min read
USFDA Med Dev Guidance: On Opioid Use Disorder & Hydrogen Peroxide-Based Contact Lens Care Products
Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder Last week (26 June, 2023) the United States Food &...
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Sharan Murugan
Jul 24, 20232 min read
USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities
Earlier today (25 June, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...
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Sharan Murugan
Jul 17, 20232 min read
USFDA Guidance: Qualification of Medical Device Development Tools
Today (17 July 2023) the USFDA's Center for Devices and Radiological Health (CDRH) released final guidance on "Qualification of Medical...
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Sharan Murugan
Jul 15, 20232 min read
USFDA Guidance: Manufacturing Changes & Comparability for CGT Products, Good Cause for Noncompliance
Last Week (13th & 14th July 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...
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Sharan Murugan
Jul 12, 20231 min read
USFDA Guidance: Considerations for Optimizing & Standardizing Diet in Clinical Trials (IEM)
Yesterday (11 July, 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated guidance on "Inborn Errors of...
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Sharan Murugan
Jun 27, 20231 min read
USFDA Guidance: Risk & Efficacy Information in Direct-to Consumer Prescription Drug Promo Labeling
A final guidance for the industry was issued today (27 June, 2023) by the US Food and Drug Administration titled "Presenting Quantitative...
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Sharan Murugan
Jun 25, 20231 min read
USFDA Guidance: Psychedelic Drugs-Considerations for Clinical Investigations
Recently last week Friday (23 June 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research released...
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Sharan Murugan
Jun 22, 20231 min read
USFDA Guidance: Formal Dispute Resolution and Administrative Hearings for OTC Monograph Drugs
Today (22 June 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research released a draft guidance on...
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Sharan Murugan
Jun 20, 20231 min read
USFDA Guidance: Pilot Program Oncology Drug Products & In Vitro Diagnostic Tests
Earlier today (20 June, 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for Drug...
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Sharan Murugan
Jun 17, 20231 min read
USFDA Guidance: Content of Premarket Submissions for Device Software Functions
Last Wednesday (14 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health, Center for...
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Sharan Murugan
Jun 8, 20231 min read
USFDA Guidance: Assessing User Fees Under the GDUFA of 2022
Today (09 June 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated final guidance on "Assessing User Fees...
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