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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 Guidance: Quality Considerations for Topical Ophthalmic Drug Products & Stimulant Use Disorder

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released two guidances earlier this week ie, "Quality...

Sharan Murugan

Oct 14, 20231 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A draft guidance "Stimulant Use Disorders: Developing Drugs for Treatment" was published yesterday (05 October, 2023) by the US Food and...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 MD Guidance: Cybersecurity-Quality System Considerations & Content of Premarket Submissions

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

Sharan Murugan

Oct 2, 20231 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

USFDA Guidance: Regulatory Considerations for Prescription Drug Use-Related Software

Yesterday (19 September 2023) the U.S. Food and Drug Administration (FDA) released two draft guidance "Regulatory Considerations for...

Sharan Murugan

Sep 20, 20232 min read

USFDA Guidance: Labeling for Biosimilar & Interchangeable Biosimilar Products

Earlier this Monday (18 September 2023), The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center...

Sharan Murugan

Sep 20, 20232 min read

USFDA M.D Guidance: Med Dev Associated with Weight Loss & Voluntary Improvement Program

Recently (14th September, 2023) the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health released multiple...

Sharan Murugan

Sep 19, 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...

Sharan Murugan

Sep 11, 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...

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...

Sharan Murugan

Sep 10, 20232 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...

Sharan Murugan

Aug 17, 20231 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...

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...

Sharan Murugan

Aug 10, 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...

Sharan Murugan

Aug 4, 20232 min read