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USFDA Guidance: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions

Yesterday (08 January, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...

Sharan Murugan

Jan 9, 20241 min read

USFDA Guidance: Considerations, Master Protocols for the Development of Drugs and Biological Products

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...

Sharan Murugan

Dec 27, 20232 min read

USFDA Guidance: Digital Health Technologies for Remote Data Acquisition & Data Standards for Drug and Biological Product Submissions and Real-World Data

Earlier this week the the U.S. Food and Drug Administration (FDA) released multiple guidances that is related to Digital Technologies and...

Sharan Murugan

Dec 27, 20232 min read

USFDA MD Guidance: Use of RWE to Support Regulatory Decision-Making forMedical Devices

Recently (14 December 2023) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices...

Sharan Murugan

Dec 19, 20232 min read

USFDA Guidance Q&A: Translation of Good Laboratory Practice Study Reports

On 21 November,2023 the USFDA issued updated guidance on "Translation of Good Laboratory Practice Study Reports: Questions and Answers"...

Sharan Murugan

Nov 24, 20232 min read

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...

Sharan Murugan

Nov 19, 20232 min read

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)...

Sharan Murugan

Nov 11, 20232 min read

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...

Sharan Murugan

Nov 6, 20232 min read

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Last Friday (03 November 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Enforcement Policy for Clinical...

Sharan Murugan

Nov 5, 20231 min read

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...

Sharan Murugan

Nov 2, 20231 min read

USFDA MD Guidance: Enforcement Policy for Non-Invasive Remote Monitoring Devices

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released a final guidance "Enforcement Policy for...

Sharan Murugan

Oct 23, 20231 min read

USFDA Guidance: Benefit-Risk Assessment for New Drug and Biological Products

A final guidance "Benefit-Risk Assessment for New Drug and Biological Products" was published last week (17 October, 2023) by the US Food...

Sharan Murugan

Oct 23, 20232 min read

USFDA Guidance: Policy for Testing of Alcohol & Developing Drugs for DFI Treatment

Earlier today (17 October 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...

Sharan Murugan

Oct 17, 20232 min read

USFDA MD Guidance: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices

Recently (10th October 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...

Sharan Murugan

Oct 14, 20231 min read

USFDA Guidance: Developing Drugs for Treatment for Stimulant Use Disorders

A draft guidance "Stimulant Use Disorders: Developing Drugs for Treatment" was published yesterday (05 October, 2023) by the US Food and...

Sharan Murugan

Oct 6, 20231 min read

USFDA Guidance: MAPP: Filing Review of Abbreviated New Drug Applications

The FDA revised section 5200.14 of the Manual of Policies and Procedures (MAPP), "Filing Reviews of Abbreviated New Drug Applications...

Sharan Murugan

Oct 4, 20232 min read

USFDA Guidance: Dose Banding - Labeling for Dosing Based on Weight or Body Surface Area

Earlier today (2 October 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Center for Biologics...

Sharan Murugan

Oct 2, 20232 min read

USFDA MD Guidance: AST System Devices, Technical Considerations & Electronic Submission Template

Recently (29th September 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...

Sharan Murugan

Oct 2, 20232 min read

USFDA Guidance: Formal Meetings Between the FDA and Sponsors or Applicants -PDUFA Products

The FDA Center for Drug Evaluation and Research, along with the FDA Center for Biologics Evaluation and Research, issued a revised draft...

Sharan Murugan

Sep 21, 20232 min read

USFDA Guidance: Conduct of Clinical Trials of Medical Products During Major Disruptions

Today (21 September 2023) CDER, along with the FDA Center for Biologics Evaluation and Research, Center for Devices and Radiological...

Sharan Murugan

Sep 21, 20231 min read