Search
USFDA Draft Guidance: Replacing Color Additives in Approved or Marketed Drug Products
A color additive is any dye, pigment, or substance that imparts color to a drug. Only color additives listed in FDA regulations are...
Sharan Murugan
May 30, 20252 min read
USFDA Announcement: Shortening the Drug Approval Process- Integration of Generative AI by June end & Completion of First AI-Assisted Scientific Review
The U.S. Food and Drug Administration (FDA) has marked a significant milestone in its digital transformation journey by announcing the...
Sharan Murugan
May 13, 20252 min read
USFDA Public Consultation: HL7 FHIR for Study Data from Real-World Data
The U.S. Food and Drug Administration (FDA) has announced a major initiative by opening a public docket seeking comments on the "...
Sharan Murugan
Apr 27, 20253 min read
USFDA Guidance: Evaluation of Sex-Specific Data in Medical Device Clinical Studies (March 2025)
In March 2025, the U.S. Food and Drug Administration (FDA) released a final guidance titled “ Evaluation of Sex-Specific Data in Medical...
Sharan Murugan
Apr 5, 20252 min read
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
USFDA Guidance: Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis and Reduce the Risk of Transmission of Mycobacterium tuberculosis
The U.S. Food and Drug Administration (USFDA) has released two important guidance documents addressing the risks of sepsis and...
Sharan Murugan
Feb 1, 20253 min read
USFDA Guidance: Bioanalytical Method Validation for Biomarkers
On 21st January 2025, the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research issued final guidance "...
Sharan Murugan
Jan 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
Latest ICH Guidance updates: M15-Model-Informed Drug Development, E6(R3)-Good Clinical Practice: Annex 2, & E11A -Pediatric Extrapolation
The International Council for Harmonisation (ICH) continues to advance global standards in drug development and clinical practices with...
Sharan Murugan
Dec 28, 20242 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