BLOGS
BLOGS
December 9, 2024
A Guide to Using FDA’s eSTAR for Medical Device Submissions
December 4, 2024
Identifying Barriers in Reporting Medical Device Adverse Effects
December 2, 2024
Adapting to Changes in EU Pharmaceutical Laws
November 25, 2024
The Future of ATMPs under EU’s Updated SoHO Regulations
November 21, 2024
Navigating the New Requirements for Diversity in Clinical Trials
November 18, 2024
What Biologics Developers Need to Know about ICH Q2 and Q14 Revisions
November 15, 2024
Accelerating Drug Development with Europe’s New Clinical Trial Pilots
November 14, 2024
What does the scenario of biosimilar cell and gene therapies look like?
November 4, 2024
Designing Effective Pharmaco-Epidemiological Studies with ICH’s M14
October 25, 2024
Updates to the Declaration of Helsinki
October 16, 2024
Expediting Access to Cell and Gene Therapy Products
September 23, 2024
Japan’s Approach to eCTD V4.0
September 17, 2024
Does the FDA need a new approval pathway?
September 3, 2024
Navigating the 505(b)(2) Approval Pathway
August 30, 2024
Specifications for In Vitro Diagnostic Devices
August 28, 2024
Faster Access to Clinical Trial Information in Europe
August 23, 2024
The Use of EDDO to Ensure Drug Delivery Function
August 20, 2024
Emerging Drug Safety Technology Program
August 8, 2024
Clinical Evaluation of Orphan Medical Devices
July 22, 2024
Impact of GenAI on Indian Healthcare
July 19, 2024
Machine Learning and Simulations for Clinical Trials
July 3, 2024
Accelerating Clinical Trials in the European Union
June 25, 2024
Enhancing Global Drug Development through ICH M11
May 30, 2024
Center for Clinical Trial Innovation
May 28, 2024
Data Integrity for In Vivo BABE Studies
May 8, 2024
Pharmacovigilance in New Zealand
April 22, 2024
Controlled Correspondence for Generic Drug Development
April 18, 2024
CMC Considerations for Human Gene Therapy INDs
April 17, 2024
Commitment to Biological Product and Patient Safety in India
April 15, 2024
Empowering Rare Disease Drug Developers
March 26, 2024
Assessing COVID-19 Symptoms in Clinical Trials
March 13, 2024
Submitting Revised ANDA Labels to Ensure Safety & Compliance
March 4, 2024
Development of CAR T Cell Products
February 27, 2024
Model-Integrated Evidence Program for Generic Drugs
February 22, 2024
Searchable Databases for Bio-Equivalence Guidance
February 14, 2024
Increasing Harmonization for Complex Generics
February 12, 2024
Strengthening Safety Compliance in Somalia
February 8, 2024
Ensuring Viral Safety of Biotechnology Products
February 5, 2024
Regulatory Roadmap for Access to MedTech
February 2, 2024
Fostering Medical Innovation with Expedited Review Processes
January 29, 2024
Easing Requirements for Minimal Risk Clinical Trials
January 23, 2024
Streamlining Clinical Investigations for Medical Devices
January 18, 2024
Third Party Review Program for Medical Devices
January 11, 2024
Effective Communication for the Safe Use of Biosimilars
January 8, 2024
Indian Pharmacopoeia Commission: Safety Alert for Mefenamic Acid
January 5, 2024
The Use of Item Response Theory in Clinical Outcome Assessments
January 3, 2024
Enhancing Medical Device Cybersecurity
January 2, 2024
Utilizing Real-World Evidence for Medical Devices
December 21, 2023
Reforming ANDA Suitability Petitions
December 19, 2023
Online Eligibility Checker Tool for International Recognition Procedure
December 15, 2023
UK MHRA: Navigating Nuances in Clinical Trial Applications
December 12, 2023
Fostering bilateral trade and harmonized efforts in medicine regulation
December 7, 2023
ANVISA & ANMAT: Mutual Recognition Agreement for Medical Devices
December 4, 2023
Advancing Healthcare through Electronic Product Information
November 28, 2023
How is EMA Addressing Medicine Shortages in Europe?
November 22, 2023
Kenya’s Systematic Approach to Pharmacovigilance
November 20, 2023
MHRA’s AI-Airlock for Safe Development of Medical Technologies
November 16, 2023
ISoP: The Need for Patient Engagement in Pharmacovigilance
November 7, 2023
AMDF: Ensuring the Safety of Donated Medical Devices
November 2, 2023
Japan PMDA: The Role of In-Country Clinical Caretakers
October 31, 2023
Regulatory Framework for Cosmetics in South Korea
October 27, 2023
Pharmacovigilance in Herbal and Alternative Medicine
October 19, 2023
Supporting Labelling Compliance with Searchable Databases
October 11, 2023
Modernization of Cosmetics Regulation Act
October 10, 2023
Ensuring Safe Use of Medical Devices in Healthcare Facilities
October 3, 2023
Prescription-Drug-Use-Related Software
September 28, 2023
Requesting Post-Warning Letter Meetings
September 20, 2023