Latest Regulatory Updates

This document from the EMA provides a list of centrally authorised products that have undergone safety-related changes to their product information, ensuring ongoing monitoring and updates for healthcare professionals and patients.

The FDA announced the Generic Drug User Fee Amendments (GDUFA) IV, outlining user fee requirements for generic drug applicants and facilities for fiscal years 2028 through 2032.

This FDA webpage provides a list of untitled letters issued to pharmaceutical companies, which are notifications that a firm's product or process violates current good manufacturing practice (CGMP) regulations.

The FDA has released a proposal for the reauthorization of the Mammalian Cell Factor IV (OMUFA) program for fiscal years 2026-2030, outlining user fee requirements and potential adjustments to processes impacting pharmaceutical companies.

The MHRA has updated its guidance for prescribers and patients regarding GLP-1 receptor agonists, addressing potential side effects and providing recommendations for safe use.

This FDA guidance document outlines the agency's current thinking on regulatory considerations for clinical decision support (CDS) software intended to be used in medical device settings.

This announcement details the Prescription Drug User Fee Amendments (PDUFA), outlining fees and performance goals for prescription drug application review processes at the FDA.

This announcement details the Over-the-Counter Monograph Drug User Fee Program (OMUFA), outlining user fee requirements and providing information for pharmaceutical companies submitting monograph drug applications.

This document provides reviews of pediatric studies conducted under the Best Pharmaceuticals for Children Act (BPCA) and pediatric assessments conducted under the Pediatric Research Equity Act (PREA) from 2012 to the present, offering insights into FDA's oversight of these requirements.

This announcement details the user fee requirements for human drug compounding outsourcing facilities (OMUFAs) as mandated by the Drug Compounding Improvement Act, outlining associated fees and reporting obligations.

This FDA webpage provides a history of eSubmitter application versions and updates, offering guidance to pharmaceutical companies on utilizing the electronic submission system for biologics applications.

The MHRA has published guidance for manufacturers, prescribers, and patients regarding GLP-1 medicines used for weight loss and diabetes, outlining key considerations related to safety, efficacy, and appropriate use.

The MHRA has strengthened warnings for GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists regarding the risk of acute pancreatitis, including necrotising and fatal cases, advising healthcare professionals to carefully assess patients before prescribing.

The MHRA has issued a recall of all quetiapine oral suspension batches manufactured by Eaststone Limited due to an incorrect amount of the active ingredient, posing a potential safety risk to patients.

The MHRA has issued a Class 1 National Patient Safety Alert for recall of Quetiapine Oral Suspension manufactured by Eaststone Limited due to a potential risk of overdosing associated with an inaccurate dosing device.

The FDA publishes and updates lists of generic drug facilities, sites, and organizations as required by the Generic Drug User Fee Amendments (GUFA) to ensure transparency and compliance within the generic drug manufacturing sector.

The FDA has issued a public health fraud alert highlighting unapproved products marketed for specific diseases and conditions, cautioning consumers against using these potentially dangerous and ineffective medications.

The FDA provides data files containing information on approved drug products, including application information, approval history, and labeling.

The MHRA has published new guidance to help people understand the regulatory oversight of mental health applications and technologies, clarifying their role and what users should consider.

This FDA announcement outlines the agency's commitment to accelerating innovative medicines approvals, modernizing processes, and enhancing public trust through a new seal and renewed focus on serving the American people.