Latest Regulatory Updates

ICH Guidances Jan 15, 2026

Updated Technical Documents Issued by ICH Expert Working Groups for Three Guidelines

The International Council for Harmonisation (ICH) has released updated technical documents for three guidelines: Q3A(R2), E2F, and P9, addressing impurities in new drug substances, genotoxic impurities, and pharmacokinetic/pharmacodynamic principles for clinical trials respectively.

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EMA Policy Jan 14, 2026

EMA and FDA set common principles for AI in medicine development

The EMA and FDA have jointly established common principles for the use of artificial intelligence (AI) in medicine development to foster innovation while ensuring patient safety, product quality, and ethical considerations.

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MHRA Guidances Jan 14, 2026

Clinical investigations for medical devices

This guidance from the MHRA details the requirements for notifying the agency about clinical investigations involving medical devices in the UK, covering aspects like protocol review, ethical approval, and investigator responsibilities.

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FDA Safety Alerts Jan 14, 2026

Early Alert: Dialysis Tubing Set Issue from Vantive

The FDA has issued an early alert regarding a potential issue with Vantive dialysis tubing sets, advising healthcare providers to inspect the product and take appropriate action due to a reported quality defect.

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FDA Approvals Jan 12, 2026

FDA Approves First Treatment for Children With Menkes Disease

The FDA approved neferelotox (brand name: Pediatrix), the first treatment for children with Menkes disease, a rare genetic disorder affecting copper metabolism.

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FDA Guidances Jan 12, 2026

FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials

The FDA issued a draft guidance outlining recommendations for modernizing statistical methods used in clinical trials, encouraging the use of innovative approaches while maintaining rigorous scientific standards and aligning with international guidelines like those from ICH.

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MHRA Guidances Jan 12, 2026

MORE Submissions - user reference guide

The MHRA has published a user reference guide for MORE Submissions, providing detailed instructions and information for submitting regulatory applications through the new digital system.

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MHRA Policy Jan 12, 2026

MHRA fees

This document outlines the fees charged by the MHRA for various regulatory services, including marketing authorization applications and post-marketing surveillance activities, applicable to both human and veterinary medicinal products.

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FDA Policy Jan 11, 2026

FDA Increases Flexibility on Requirements for Cell and Gene Therapies to Advance Innovation

The FDA is increasing flexibility in certain requirements for cell and gene therapy product applications to foster innovation while maintaining safety and quality standards.

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EMA Guidances Jan 9, 2026

IRIS guide for applicants - How to create, submit and manage IRIS applications, for industry and individual applicants

This guideline from the EMA provides detailed instructions for applicants on how to create, submit, and manage applications through the IRIS system, covering both industry and individual applicant scenarios.

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FDA Safety Alerts Jan 9, 2026

Organ Recovery Pack Correction: AVID Medical Issues Correction for Medical Convenience and Organ Recovery Kits

AVID Medical is issuing a correction for certain medical convenience and organ recovery kits due to a quality control issue that may impact the sterility of the products.

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FDA Safety Alerts Jan 9, 2026

Modern Warrior Recalls “Modern Warrior Ready” Dietary Supplement Due to Undeclared 1,4-DMAA and Aniracetam, as Well as Tianeptine, Which has Not Been Approved for Supplement Use by the FDA.

Modern Warrior is recalling its "Modern Warrior Ready" dietary supplement due to the undeclared presence of 1,4-DMAA and aniracetam, as well as tianeptine, a substance not approved for use in supplements by the FDA.

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FDA Safety Alerts Jan 9, 2026

Anthony Trinh, 123Herbals LLC (123HERBALS.COM) Issues Nationwide Recall of Silintan Capsules Due to the Presence of Undeclared Meloxicam

123Herbals LLC is voluntarily recalling Silintan capsules nationwide due to the undeclared presence of meloxicam, a potentially harmful ingredient not listed on the product label.

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ICH Guidances Jan 6, 2026

Presentation and Training Materials Now Available for Draft Guideline on Patient Preference Studies

The International Council for Harmonisation (ICH) has released presentation and training materials to support understanding of the draft guideline on Patient Preference Studies, aiming to harmonize approaches globally.

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FDA Safety Alerts Jan 5, 2026

Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters

Bard is voluntarily recalling its PowerPICC Intravascular Catheters due to a potential risk of fracture during use, which could lead to patient injury.

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FDA Safety Alerts Jan 5, 2026

Infusion Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System Platforms

Baxter is voluntarily recalling software versions for its Sigma Spectrum infusion system platforms due to a potential quality defect that could impact pump performance and potentially harm patients.

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FDA Safety Alerts Jan 5, 2026

Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters

Conavi Devices, Inc. is recalling its Novasight Hybrid Catheters due to a potential quality defect that could compromise device performance and potentially harm patients.

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FDA Safety Alerts Jan 5, 2026

Aspiration System Correction: Calyxo Updates Use Instructions for CVAC Aspiration Systems

Calyxo Medical, Inc. is issuing a correction to the use instructions for its CVAC Aspiration Systems due to concerns regarding potential aspiration events and recommending specific actions for users.

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FDA Safety Alerts Jan 5, 2026

Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Bravo CF Capsule Delivery Devices

Medtronic and Given Imaging are voluntarily recalling Bravo CF capsule delivery devices used for esophageal pH monitoring due to a potential risk of capsule detachment and false results.

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FDA Safety Alerts Jan 5, 2026

Infusion Pump Recall: Fresenius Kabi Removes Ivenix Large Volume Pumps

Fresenius Kabi is recalling Ivenix large volume infusion pumps due to a potential software bug that could cause the pump to deliver infusions at incorrect rates, posing a risk to patients.

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