Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device

Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...

Sharan Murugan

Mar 30, 20231 min read

USFDA MD Guidance: Cybersecurity-Refuse to Accept Policy for Cyber Devices & Related Systems

Earlier today (30 March 2023) USFDA's Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research...

Sharan Murugan

Mar 30, 20232 min read

USFDA Update: In-Person, Face-to-Face ANDA Program Meetings

Starting from March 27, 2023, the FDA generic drug program will resume in-person face-to-face (FTF) meetings with the industry along with...

Sharan Murugan

Mar 28, 20231 min read

USFDA Guidance: General Considerations for Animal Studies Intended to Evaluate Medical Devices

Today (27 March 2023) USFDA's Center for Devices and Radiological Health released final guidance on "General Considerations for Animal...

Sharan Murugan

Mar 27, 20232 min read

USFDA MD Guidance: Transition Plan for M.D Issued Emergency Use Authorizations Related to COVID-19

On 24 March 2023, USFDA's Center for Devices and Radiological Health released two final guidances on "Transition Plan for Medical Devices...

Sharan Murugan

Mar 24, 20231 min read

USFDA Guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Products

Earlier today (24 March 2023) USFDA's Oncology Center of Excellence released a draft guidance on "Clinical Trial Considerations to...

Sharan Murugan

Mar 24, 20231 min read

USFDA Guidance: Pharmacogenomic Data Submissions

Earlier today (16 March 2023) the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER), Center for Biologics...

Sharan Murugan

Mar 17, 20231 min read

USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A

A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...

Sharan Murugan

Mar 16, 20231 min read

USFDA Guidance: CMC-Potency Assay Considerations for Monoclonal Antibodies & Therap. Protiens

Earlier today (01 March, 2023) USFDA released a draft guidance on "Potency Assay Considerations for Monoclonal Antibodies and Other...

Sharan Murugan

Mar 1, 20231 min read

ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products

In today's FDA press release, the ICH final guidance titled "Q13 Continuous Manufacturing of Drug Substances and Drug Products" was...

Sharan Murugan

Mar 1, 20231 min read

USFDA Med. Device: Guidance on Laser Products, Diagnostics, X-ray & Ultrasonic Diathermy Devices

The Center for Devices and Radiological Health released multiple guidances earlier today (21-February-2023), related to "Laser Products,...

Sharan Murugan

Feb 21, 20232 min read

USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants

The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...

Sharan Murugan

Feb 19, 20232 min read

ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms

The USFDA released draft guidance for the industry on January 31, 2023, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage...

Sharan Murugan

Feb 1, 20231 min read

USFDA Guidance: Design and Conduct of Externally Controlled Trials for Drug and Biological Products

Earlier today, the FDA published a draft guidance for the industry titled, "Considerations for the Design and Conduct of Externally...

Sharan Murugan

Jan 31, 20231 min read

USFDA Guidance: Content & Format - Dosage and Administration Section of Labeling

Recently on 12-January-2023, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...

Sharan Murugan

Jan 17, 20231 min read

USFDA Guidance: Photobiomodulation (PBM) Devices & Premarket Notification [510(k)] Submissions

Recently (12-January-2023) the US Food and Drug Administration (FDA) relaeased draft guidance on "Photobiomodulation (PBM) Devices -...

Sharan Murugan

Jan 16, 20231 min read

USFDA Guidance: Finalized REMS Format, Content and Technical Conformance Guide

The US Food and Drug Administration (FDA) relaeased finalized the guidance on "Format and Content of a REMS Document" and "REMS Document...

Sharan Murugan

Jan 4, 20231 min read

USFDA Guidance: Controlled Correspondence Related to Generic Drug Development

Recently on 21-December-2022, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...

Sharan Murugan

Dec 27, 20221 min read

USFDA Guidance: Failure to Respond to an ANDA Complete Response Letter

Yesterday (14-December-2022), USFDA published the revised final guidance “Failure to Respond to an ANDA Complete Response Letter Within...

Sharan Murugan

Dec 15, 20221 min read

USFDA ME Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program

Recently on 12-December-2022 USFDA's Center for Biologics Evaluation and Research and Center for Devices and Radiological Health released...

Sharan Murugan

Dec 14, 20221 min read