Pharma & Drug Safety

ANSM Safety Information: Mobile Hoist and Bath Elevator

The French National Agency for Medicines and Health Products Safety (ANSM) has issued safety information regarding a mobile hoist and bath elevator from Mangar International. This notice, registered under number R2607055, alerts home healthcare providers and retailers to a safety action implemented by the manufacturer.

Health Canada Implements ICH Pharmaceutical Guidelines

Health Canada is implementing new International Council for Harmonisation (ICH) guidelines for pharmaceuticals, including M13A and Q12/Q14. These implemented ICH guidelines will take precedence over existing Health Canada guidance documents where discrepancies exist, potentially leading to amendments or withdrawals of current guidance.

ICH Consultations on Patient Preference, Extractables, and Adaptive Trials

Health Canada announced three International Council for Harmonisation (ICH) draft guidelines are open for public consultation. The consultations cover patient preference studies, extractables and leachables, and adaptive clinical trials, with comment deadlines ranging from November 2025 to April 2026.

Health Canada Implements ICH Q12 and Q14 Guidance

Health Canada has announced the implementation of International Council for Harmonisation (ICH) Q12 and Q14 guidance. The initial scope focuses on Post Approval Change Management Protocols (PACMPs) for Biologic and Radiopharmaceutical Drugs Directorate products, with further implementation details to follow.

Health Canada Proposes Reliance on Foreign Drug Authority Decisions

Health Canada is proposing a new Ministerial Reliance Order (MRO) that would allow the Minister to examine new drug submissions by relying on decisions from foreign regulatory authorities. This initiative is part of a broader Red Tape Review aimed at facilitating earlier drug availability in Canada while maintaining safety and quality standards. A 70-day consultation period is currently underway.

Health Product Shortages in Canada: 2024-2025 Review

Health Canada has released its review of health product shortages for the 2024-2025 fiscal year. The report details drug and medical device shortages, including reporting requirements for manufacturers and highlights of high-impact cases. It notes a decrease in new drug shortage reports compared to the previous year.

Lidl US Recalls Chocolate Ladybugs Due to Undeclared Hazelnut

Lidl US is recalling all lots of Favorina Chocolate Ladybugs - German-Style Nougat due to undeclared hazelnut allergen. The product was distributed to Lidl US stores in several East Coast states between January and March 2026. Consumers with hazelnut allergies are at risk of serious reactions.

Insulet Recalls Omnipod 5 Pods Due to Manufacturing Issue

Insulet Corporation is initiating a voluntary medical device correction for specific lots of Omnipod 5 Pods due to a manufacturing issue that may cause insulin leaks. The FDA has been notified of this action, which impacts approximately 1.5% of global production. Customers can check lot numbers online and request replacement pods.

SAMHSA Extends NSDUH Field Tests; Comment Deadline May 12

The Substance Abuse and Mental Health Services Administration (SAMHSA) has extended the field tests for the National Survey on Drug Use and Health (NSDUH). The agency is requesting public comments on this extension, with a deadline of May 12, 2026.

HHS-Certified Laboratories for Urine/Oral Fluid Drug Testing

The Substance Abuse and Mental Health Services Administration (SAMHSA) has published the current list of HHS-certified laboratories and instrumented initial testing facilities for urine and oral fluid drug testing. This notice serves as an informational update for federal agencies and relevant parties.