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 determines that a REMS is necessary to ensure the benefits of a drug or biological product outweigh its risks.
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 requires careful consideration to ensure transparency, reliability, and compliance with established guidelines.
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 their regulation. The new rules are intended to streamline and update how OTC drugs are brought to market, offering clearer pathways for both manufacturers and regulators.
Pharmacovigilance System Master File (PSMF): Its Importance and Regulatory Role in Ensuring Drug Safety
The Pharmacovigilance System Master File (PSMF) is a key regulatory requirement under the EU pharmacovigilance legislation, ensuring that medicinal products authorized in the European Union (EU) comply with the stringent safety monitoring and reporting standards. Its primary objective is to provide a detailed description of the pharmacovigilance (PV) system in place, documenting the structure, processes, and the responsibilities of stakeholders involved in drug safety.