Category: Regulatory

Overview of FDA Covered Product Authorization (CPA) and the CREATES Act What is FDA Covered Product Authorization (CPA)? FDA Covered Product Authorization refers to the official approval given by the U.S. Food and Drug Administration (FDA) for certain medical products to be marketed in the United States.

Health Canada Validation Criteria 5.3 – Compliance Update Effective May 31, 2025 As part of our continued commitment to regulatory compliance and operational excellence, we are notifying our clients, partners, and stakeholders about important updates to Health Canada’s Validation Criteria, version 5.3, which will come into effect on May 31, 2025.

Swissmedic Nitrosamine Risk Assessment Requirements Swiss agency updated the guidance on nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents.

Scheduled Maintenance Notice: ESG NextGen Platform Downtime on May 17, 2025

Navigating EMA’s Updated Paediatric Application Procedures: April 2025 Insights On 15 April 2025, the European Medicines Agency (EMA) released an updated version (Rev. 121) of its procedural advice on paediatric applications (EMA/672643/2017). This revision reflects the agency’s commitment to streamlining regulatory processes, enhancing transparency, and supporting innovation in paediatric medicine development across the EU.

Understanding ACA Section 6004: Ensuring Drug Safety and Transparency in Healthcare On March 23, 2010, the Affordable Care Act (ACA) was signed into law. Among other things, the ACA amends the Social Security Act, 42 U.S.C. 1301 et seq., by adding section 6004. This new section requires the submission of certain drug sample information to… Continue reading Understanding ACA Section 6004: Ensuring Drug Safety and Transparency in Healthcare

Risk Evaluation and Mitigation Strategies (REMS) The Food and Drug Administration Amendments Act (FDAAA) of 2007, signed on September 27, 2007, by President George W. Bush, created section 505-1 of the Food, Drug, and Cosmetic Act (FD&C Act) which authorizes FDA to require a Risk Evaluation and Mitigation Strategies (REMS) for certain drugs if FDA… Continue reading Risk Evaluation and Mitigation Strategies (REMS) Overview

MHRA Launches New Monthly Safety Roundup Bulletin and Redesigned Safety Alerts The MHRA has introduced a new monthly safety bulletin, the MHRA Safety Roundup, as part of its three-year strategy to enhance safety communications. This initiative aims to make information about medicines and medical devices clearer and more accessible for healthcare professionals.

Guideline for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products Artificial Intelligence (AI) is rapidly transforming various industries, including the pharmaceutical sector. Regulatory authorities are increasingly exploring AI-driven tools to enhance decision-making processes related to drug and biological product approvals. However, the integration of AI in regulatory science… Continue reading Guideline for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products

CARES Act Section 505G: Modernizing OTC Drug Monographs The CARES Act, signed into law on March 27, 2020, brought significant changes to the regulatory framework governing Over-the-Counter (OTC) drugs in the U.S. Section 505G, which was added to the Federal Food, Drug, and Cosmetic (FD&C) Act, specifically addresses OTC monograph drugs and aims to modernize… Continue reading CARES Act Section 505G: Modernizing OTC Drug Monographs