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FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...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

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 : CMC Guidance Reformulating Drug Products That Contain Carbomers & Potency Assurance for Cellular & Gene Therapy 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 30, 20232 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