Clinical trials for medicines: modifying a clinical trial approval
Guidance on the various types of modifications that can be made to a clinical trial approval.
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Clinical trials regulations: transitional arrangements
Guidance on transitional arrangements for applying for clinical trial approval.
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Clinical trials: Non-investigational medicinal products
Guidance on using non-investigational medicinal products in a clinical trial.
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Clinical trials for medicines: collection, verification, & reporting of safety events
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
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Ongoing | Cancer Accelerated Approvals
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit. -
Weight Loss Product Notifications
Learn about the warnings for weight loss products that contain hidden drugs and other hidden ingredients. -
Toki Slimming Candy may be harmful due to hidden drug ingredients
Toki Slimming Candy may be harmful due to hidden drug ingredients. The Food and Drug Administration is advising consumers not to purchase or use Toki Slimming Candy, a product promoted and sold for weight loss on various websites, including www.eBay.com, and possibly in some retail stores. -
Patient Engagement Collaborative
The Patient Engagement Collaborative (PEC) is an advancement in the FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Public Engagement Staff. -
Field Safety Notices: 16 to 20 June 2025
List of Field Safety Notices from 16 to 20 June 2025.
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Import Alerts for Certain Olympus Medical Devices Manufactured in Japan – Letter to Health Care Providers
The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries. -
Transparency data: Medicines and Healthcare products Regulatory Agency spending over £25,000: 2025 to 2026
Information on Medicines and Healthcare products Regulatory Agency spending over £25,000.
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Laboratory Information Bulletins
Laboratory Information Bulletins available to the public