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USFDA Guidance: Cancer Clinical Trial Eligibility Criterias

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, Center for Drug Evaluation and Research, and Center for...

Sharan Murugan

Apr 27, 20242 min read

USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A

On 24 April 2026 (Wednesday) the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research released a...

Sharan Murugan

Apr 27, 20242 min read

USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies

Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...

Sharan Murugan

Apr 4, 20242 min read

USFDA Guidance: Regional Implementation Guide for E2B (R3) e-Transmission of ICSR and Providing Regulatory Submissions in Electronic Format: IND Safety Reports

Today (01 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...

Sharan Murugan

Mar 30, 20242 min read

USFDA Guidance: Handling and Retention of Bioavailability (BA) & Bioequivalence (BE) Testing Samples

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research updated and released the draft guidance "Handling and...

Sharan Murugan

Mar 27, 20242 min read

USFDA Guidance: Controlled Correspondence Related to Generic Drug Development

On 18th March, 2024 the U.S. Food and Drug Administration (FDA) the Center for Drug Evaluation and Research released the final guidance...

Sharan Murugan

Mar 20, 20242 min read

USFDA Guidance: Annual Reportable Labeling Changes for NDA and ANDA for Nonprescription Drug Products

Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released the draft guidance...

Sharan Murugan

Mar 13, 20242 min read

USFDA Med.Dev: Draft Guidance Select Updates for the Premarket Cybersecurity -Section 524B of the FD&C Act

Today (13 March, 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research Center for Devices and...

Sharan Murugan

Mar 13, 20241 min read

USFDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates

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

Sharan Murugan

Mar 5, 20242 min read

USFDA Guidance: Reporting Amount of Listed Drugs and Biological Product and Key Information and Facilitating Understanding in Informed Consent Guidance

Earlier this week (26 & 29 February 2024) the the U.S. Food and Drug Administration (FDA) released two guidances "Reporting Amount of...

Sharan Murugan

Mar 2, 20242 min read

USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know

Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational...

Sharan Murugan

Feb 17, 20241 min read

USFDA Guidance: Use of Data Monitoring Committees in Clinical Trials

Today (13 February 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, Center for Devices...

Sharan Murugan

Feb 13, 20242 min read

USFDA CMC Guidance: Advanced Manufacturing Technologies Designation Program

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

Sharan Murugan

Feb 13, 20242 min read

USFDA Guidance: "Understanding FDA's QMSR Final Rule: What You Need to Know for the Transition Period"

The U.S. Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and effectiveness of medical devices. In pursuit...

Sharan Murugan

Feb 4, 20242 min read

USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...

Sharan Murugan

Jan 31, 20241 min read

USFDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing & Development of Chimeric Antigen Receptor (CAR) T Cell Products

On Monday (29 January 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation released two...

Sharan Murugan

Jan 31, 20242 min read

USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers

Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...

Sharan Murugan

Jan 28, 20242 min read

USFDA Guidance: Navigating ANDA Submissions Latest Guidance on ANDA Amendments, Requests, and Labeling Revisions

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released two updated final guidances on 24 January...

Sharan Murugan

Jan 28, 20242 min read

USFDA's ISTAND Pilot Program: Accepts First Submission of AI-Based Digital Tech for Neuroscience

A new submission has been accepted into the FDA's Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program by...

Sharan Murugan

Jan 23, 20242 min read

USFDA Guidance: Requests for Reconsideration under GDUFA

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

Sharan Murugan

Jan 13, 20242 min read