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FDA warning letters target two firms in India for GMP violations, US sponsor for BIMO ...

The US Food and Drug Administration (FDA) sent warning letters to an active pharmaceutical ingredient (API) supplier and a pharmaceutical company in India for violating current good manufacturing ...
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FDA questions on genAI-enabled chatbots raise concerns from expert panel

During the second meeting of the US Food and Drug Administration@s (FDA) Digital Health Advisory Committee (DHAC), members of the panel seemed shocked and, at times, lost for words when grappling with ...
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The impact of US state law initiatives for food ingredients on the food industry

This article discusses the impact of US state laws banning food ingredients. It examines two recently enacted state laws that require a warning or disclosure statement on the label, but do not ...
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Medtech industry calls for major reforms to MDR and IVDR

Medical device and pharmaceutical industry groups in the EU and US are urging significant changes to the EU@s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Europe@s ...
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FDA seeks input on evaluating AI-enabled medical devices

The US Food and Drug Administration@s (FDA) Center for Devices and Radiological Health (CDRH) is seeking input on methods for assessing and evaluating AI-enabled medical devices in a newly released ...
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Shutdown: FDA will not accept submissions until funding resumes

The US Food and Drug Administration (FDA) will only conduct vital and mission critical activities amid a government shutdown that began Wednesday after Congress failed to reach a deal to fund the ...
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FDA official updates on advancing RWE program, lists common reasons for rejection

Some of the main reasons the US Food and Drug Administration (FDA) rejects applicants from participating in its Advancing Real-World Evidence (RWE) Program include concerns that proposed real-world ...
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FDA finalizes device production and quality system software guidance

@The US Food and Drug Administration@s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...
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FDA posts more than 100 warning and untitled letters in ad crackdown

The US Food and Drug Administration (FDA) has published scores of warning letters, most of them to companies for marketing and advertising compounded versions of glucagon-like Peptide-1 (GLP-1) ...
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FDA’s latest regulatory agenda pulls LDT rule, spells out plans to issue a final rule on NDC

The Office of Management and Budget (OMB) released the Spring 2025 regulatory agenda on Thursday, laying out the planned proposed and final rules the federal government plans to issue. @ ...
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MDUFA VI: FDA eyes growth while industry seeks refinement

SILVER SPRING, MD @ Medtech industry stakeholders kicked off the latest round of medical user fee negotiations by stressing they want to ensure user fees supplement Congressionally appropriated ...
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FDA, ASCO propose principles for proper dosing in cancer drug development

The US Food and Drug Administration (FDA) and the American Society of Clinical Oncology (ASCO) have laid out several principles for cancer drug developers to ensure more nuanced dosing. The principles ...