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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A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...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Earlier today (01 March, 2023) USFDA released a draft guidance on "Potency Assay Considerations for Monoclonal Antibodies and Other...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The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...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The USFDA released draft guidance for the industry on January 31, 2023, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage...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Earlier today, the FDA published a draft guidance for the industry titled, "Considerations for the Design and Conduct of Externally...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Recently on 12-January-2023, U.S Food and Drug Administration announced the availability of a draft guidance for industry entitled...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
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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
USFDA Guidance: Homeopathic Drugs Products
Earlier Today (07-December-2022), the U.S. Food and Drug Administration issued a final guidance, "Drug Products Labeled as Homeopathic...
Sharan Murugan
Dec 7, 20221 min read
USFDA Guidance: Selective Approach to Safety Data Collection & Dosing Regimens of PD1 & PD-L1
Earlier today USFDA's Center for Drug Evaluation and Research (CDER) & Oncology Center of Excellence released the updated final guidance...
Sharan Murugan
Dec 6, 20221 min read
USFDA Guidance: Statistical Approaches to Establishing Bioequivalence
Today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft guidance...
Sharan Murugan
Dec 2, 20221 min read
USFDA Guidance: ANDAs Pre-Submission Facility Correspondence Related to Prioritized Generic Drug
Earlier today (o2-Dec-2022) U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) released a revised draft...
Sharan Murugan
Dec 2, 20221 min read
USFDA: First Drug Approved by FDA to Delay Type 1 Diabetes Onset
Yesterday (18-November-2022) Tzield (teplizumab-mzwv) injection from ProventionBio has been approved by the U.S. Food and Drug...
Sharan Murugan
Nov 19, 20221 min read
USFDA POLICY AND PROCEDURES: Quality Assessment for Products in Expedited Programs
Recently (10 November 2022), the U.S. Food and Drug Administration published a new Manual of Policies and Procedures (MAPP), MAPP 5015.13...
Sharan Murugan
Nov 12, 20221 min read