Search
USFDA Announcement: Facility Fee Rates for OTC Monograph Drug User Fee Program (OMUFA) for FY 2025
The U.S. Food and Drug Administration (FDA) has announced the release of " Over-the-Counter Monograph Drug User Fee Program-Facility Fee...
Sharan Murugan
Mar 21, 20252 min read
UK MHRA Med Dev Guidance: Applying Human Factors to Medical Devices
The Medicines and Healthcare Products Regulatory Agency (MHRA) published its comprehensive guidance titled “ Applying Human Factors and...
Sharan Murugan
Jan 16, 20252 min read
USFDA Med Dev Guidance: Premarket Approval Application and Humanitarian Device Exemption Modular Review
The U.S. Food and Drug Administration (FDA) released final guidance " Premarket Approval Application and Humanitarian Device Exemption...
Sharan Murugan
Jan 16, 20252 min read
USFDA Guidance: Considerations for Complying with 21 CFR 211.110
The US Food and Drug Administration (FDA) has released the Draft Guidance document titled " Considerations for Complying with 21 CFR...
Sharan Murugan
Jan 6, 20252 min read
USFDA Guidance: Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
The U.S. Food and Drug Administration (FDA) recently released (26 December 2024) draft guidance titled “ Protocol Deviations for Clinical...
Sharan Murugan
Dec 28, 20242 min read
USFDA Guidance: Global Unique Device Identification Database (GUDID): Enhancing Medical Device Transparency
The U.S. Food and Drug Administration (FDA) has updated and released its " Global Unique Device Identification Database (GUDID) " final...
Sharan Murugan
Dec 21, 20242 min read
USFDA: CDER Establishes New Center for Real-World Evidence Innovation (CCRI)
The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has unveiled an innovative initiative—the CDER...
Sharan Murugan
Dec 15, 20242 min read
USFDA Guidance: Standardized Format for Electronic Submission of NDA and BLA Content for Bioresearch Monitoring (BIMO) Inspections
The United States Food and Drug Administration (USFDA) has released detailed guidance" Standardized Format for Electronic Submission of...
Sharan Murugan
Dec 9, 20242 min read
USFDA Draft Guidance: Accelerated Approval – Expedited Program for Serious Conditions
The United States Food and Drug Administration (USFDA) has released (05 December, 2024) the draft guidance " Expedited Program for...
Sharan Murugan
Dec 9, 20242 min read
USFDA Final Guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
The US Food and Drug Administration (USFDA) has issued its final guidance on " Marketing Submission Recommendations for a Predetermined...
Sharan Murugan
Dec 9, 20242 min read
USFDA Guidance: Enhancing Communication and Guidance Development Practices
The US Food and Drug Administration (USFDA) has released two insightful reports aimed at improving its internal practices and...
Sharan Murugan
Dec 4, 20242 min read
USFDA MD Guidance: Enhancing Safety and Efficiency in Orthopedic Devices and Sterilization Processes
The USFDA Center for Devices and Radiological Health has recently issued three key final guidance documents focusing on orthopedic...
Sharan Murugan
Nov 27, 20242 min read
USFDA Guidance: 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review
The 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review are pivotal initiatives by the USFDA to...
Sharan Murugan
Nov 20, 20242 min read
USFDA Guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics
This USFDA draft guidance" Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutic s" , issued on 15 November 2024, offers...
Sharan Murugan
Nov 16, 20242 min read
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
The Study Data Technical Conformance Guide (SDTCG) from the USFDA provides a framework to help sponsors submit standardized study data...
Sharan Murugan
Nov 9, 20242 min read
USFDA Guidance: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
Recently 30th October, 2025 the U.S. Food and Drug Administration (FDA) issued guidance titled " M13A: Bioequivalence for...
Sharan Murugan
Nov 1, 20242 min read
US FDA Draft Guidance: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
The US FDA released a draft guidance on 21st October 2024 outlining the recommendations for " Drug Interaction Information in Human...
Sharan Murugan
Oct 22, 20242 min read
USFDA Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials & Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
The U.S. Food and Drug Administration (USFDA) yesterday (17 October, 2024) has issued two comprehensive Q&A guidance titled " Core...
Sharan Murugan
Oct 17, 20242 min read
USFDA Guidance : Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
The U.S. Food and Drug Administration (USFDA) has issued comprehensive Q&A guidance titled " Electronic Systems, Electronic Records, and...
Sharan Murugan
Oct 2, 20242 min read
USFDA Medical Device: Guidance on Dental Products (Dental Impression Materials, Dental Ceramics, Dental Cements and Air Powered Dental Handpieces and Air Motors)
USFDA's Center for Devices and Radiological Health has released four final guidances about dental products, such as Dental Impression...
Sharan Murugan
Sep 28, 20242 min read