Latest Regulatory Updates

The FDA is seeking input from stakeholders on the development and evaluation of abuse-deterrent formulations for central nervous system stimulant drugs to inform future guidance.

The FDA issued a brief reiterating the importance of vaccines, specifically the Measles, Mumps, and Rubella (MMR) vaccine, to protect public health and address recent outbreaks.

This FDA timeline details selected activities and significant events from 2017 to the present, outlining the agency's framework and efforts addressing substance use disorders and overdose prevention through various initiatives and policy changes.

The MHRA has published a register of electronic export certificates for human medicines, providing transparency and facilitating the tracking of exports from the UK.

The FDA's Office of Hematology and Oncology Products is being reorganized and renamed the Office of Oncologic Diseases to better reflect its focus on cancer treatment development.

The FDA is encouraging the inclusion of male patients in breast cancer clinical trials to better understand potential differences in treatment response and outcomes.

The FDA will hold a Pediatric Advisory Committee meeting to discuss the safety review of certain drugs used in pediatric populations.

This MHRA announcement details field safety notices issued between January 26 and January 30, 2026, concerning potential quality defects or issues with specific medicinal products and medical devices.

This webpage provides biographical information for the leadership team within the FDA's Center for Drug Evaluation and Research (CDER).

This FDA announcement details the agency's requirements and processes for receiving and managing postmarketing reports, commitments, and requirements from pharmaceutical companies as part of drug approval agreements.

The FDA has updated a draft guidance document providing additional clarity and revisions related to the rare pediatric disease priority review voucher program, which incentivizes drug development for rare pediatric conditions.

During National Infant Immunization Week, the FDA released a statement reinforcing its confidence in the safety and effectiveness of vaccines and emphasizing the importance of immunization to prevent diseases.

The UK government, in collaboration with the MHRA, has launched a new initiative called 'Mila to Millions' to accelerate access to individualized medicines, including gene and cell therapies, through streamlined regulatory pathways and incentives for developers.

The MHRA has issued a Class 2 medicine recall for Accord Healthcare Ltd's Carmustine 100 mg Powder and Solvent for Concentrate for Solution for Infusion due to a quality defect affecting the sterility of the product.

This guideline from the EMA provides recommended submission dates for veterinary medicinal product applications to ensure efficient assessment timetables and facilitate international collaboration.

The FDA is launching a voluntary PreCheck pilot program to provide feedback and guidance to domestic pharmaceutical manufacturers on their manufacturing processes before submitting applications, aiming to strengthen quality and reduce deficiencies.

This FDA announcement provides a list of determinations, including written requests, related to drug applications and approvals.

This FDA webpage lists non-compliance letters issued under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act, detailing instances where facilities failed to comply with requirements related to applications for drug products.

This FDA webpage provides a comprehensive list of vaccines currently licensed for use in the United States, including their manufacturers and indications.

This FDA webpage provides information and resources related to Registered Outsourcing Facilities (ROFs) under the Compounding Quality Act, outlining requirements for registration, inspections, and compliance with current Good Manufacturing Practice (CGMP) regulations.