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449 changes

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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.

Priority review Consultation Pharmaceuticals
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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.

Priority review Guidance Pharmaceuticals
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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.

Priority review Enforcement Food Safety
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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.

Urgent Notice Healthcare
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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.

Routine Notice Healthcare
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SAMHSA Proposed Collection for Underage Drinking Prevention Activities

The Substance Abuse and Mental Health Services Administration (SAMHSA) has published a notice requesting public comment on a proposed collection of information related to underage drinking prevention activities. This notice initiates a 60-day comment period for interested parties.

Priority review Notice Public Health
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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.

Priority review Notice Healthcare
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HSA Seizes Over $1.1M in Vaporisers

The Health Sciences Authority (HSA) seized over $1.1 million worth of vaporisers in an operation on February 24, 2026. New penalties under the Tobacco and Vaporisers Control Act (TVCA) will take effect from May 1, 2026, targeting importers, suppliers, and premises owners.

Priority review Enforcement Consumer Protection
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NY Health Urges Colorectal Cancer Screening for Adults 45+

The New York State Department of Health is urging adults aged 45 and older to get screened for colorectal cancer, as it is now a leading cause of cancer death for those under 50. The department highlights that screening can prevent or detect the cancer early, and aims to improve current screening rates across the state.

Priority review Notice Public Health
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WHO Expert Committee on Specifications for Pharmaceutical Preparations 57th Report

The WHO Expert Committee on Specifications for Pharmaceutical Preparations has released its 57th report, recommending new and revised guidance texts for pharmaceutical quality assurance. These include updated GMP for excipients, new GMP for radiopharmaceutical cold kits, revised lab quality control practices, and updated biowaiver guidelines.

Priority review Guidance Pharmaceuticals

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