Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

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...

Sharan Murugan

Jun 8, 20231 min read

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...

Sharan Murugan

Jun 8, 20231 min read

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The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good...

Sharan Murugan

Jun 6, 20231 min read

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...

Sharan Murugan

Jun 5, 20231 min read

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...

Sharan Murugan

Jun 4, 20232 min read

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...

Sharan Murugan

Jun 4, 20231 min read

USFDA Guidance: Covariates RCT, Non-Clinical Performance Assessment of Tissue & Efficacy Endpoints

Today (26 May 2023) the United States Food & Drug Administration released multiple guidances related to both drugs/biologics and medical...

Sharan Murugan

May 25, 20232 min read

USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications

Yesterday (24 May, 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research (CBER) ánd Center...

Sharan Murugan

May 25, 20232 min read

USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations

The United States Food & Drug Administration released two draft guidelines today (18-May-2023) "Pediatric Drug Development: Regulatory...

Sharan Murugan

May 18, 20232 min read

USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products

This week (11 & 12 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...

Sharan Murugan

May 13, 20231 min read

USFDA Guidance: Assessing User Fees Under the PDUFA of 2022

This Monday (01 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...

Sharan Murugan

May 4, 20231 min read

ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management

Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...

Sharan Murugan

May 4, 20231 min read

USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices

Today (02 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, Center for Biologics...

Sharan Murugan

May 2, 20232 min read

ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products

On 27th April, 2023 the United States Food & Drug Administration Center for Drug Evaluation and Research, and Center for Biologics...

Sharan Murugan

Apr 29, 20232 min read

USFDA Guidance: Animal Rule Developing Drugs for Prevention & Treatment "Acute Radiation Syndrome"

Last week (19 April, 2023) the United States Food & Drug Administration released a new draft guidance on "Acute Radiation Syndrome:...

Sharan Murugan

Apr 23, 20231 min read

USFDA Guidance: Transdermal and Topical Delivery Systems for ANDAs

Today (12 April 2023) USFDA's Center for Drug Evaluation and Research released two draft guidances on"Assessing Adhesion With Transdermal...

Sharan Murugan

Apr 12, 20231 min read

USFDA Guidance: Format and Content for OTC Monograph Order Requests

Earlier today (12 April 2023) USFDA's Center for Drug Evaluation and Research released a draft guidance on"Over-the-Counter Monograph...

Sharan Murugan

Apr 12, 20231 min read

USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations

Earlier today (11th April 2023) USFDA released final guidance on"A Risk-Based Approach to Monitoring of Clinical Investigations Questions...

Sharan Murugan

Apr 11, 20231 min read

USFDA Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products &API

Today (o5 April 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft...

Sharan Murugan

Apr 5, 20232 min read

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...

Sharan Murugan

Mar 31, 20231 min read