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This Week at FDA: New guidance, shutdown pay issues, and another inspection overhaul

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, FDA ...
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FDA warning letters target two firms in India for GMP violations, US sponsor for BIMO violations

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 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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Asia-Pacific Roundup: China updates GMPs for medical devices, starts 1-year transition to new rules

China@s National Medical Products Administration (NMPA) updated its guidance on good manufacturing practices (GMPs) for medical devices.
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7-year FDA review finds improved GCP compliance

A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...
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FDA finalizes bacterial pneumonia drug development guidances

The US Food and Drug Administration (FDA) on Wednesday finalized two guidances on developing drugs to treat community-acquired or hospital-acquired and ventilator-associated bacterial pneumonia. Both ...
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FDA finalizes guidance on microneedling devices

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FDA Renames and Restructures Oncology Office

The US Food and Drug Administration’s (FDA) office responsible for approving cancer therapies has been renamed the Office of Oncologic Diseases (OOD) and restructured to add new divisions, the agency ...
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FDA Finalizes Guidance Closing Pediatric Study Loophole

The US Food and Drug Administration (FDA) on Thursday finalized guidance stating that it does not intend to grant orphan drug designation for pediatric subpopulations of common diseases in an effort ...
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FDA issues new standards for DTC prescription drug ads

Overall, consumers understood the risk information better when they saw the same risk information in audio format with a verbatim text accompaniment. However, they did not find that contrasting ...
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The Drug Regulatory Landscape in the ASEAN Region

This article provides an overview of critical regulatory requirements to be considered for Association of Southeast Nations (ASEAN) pharmaceutical markets and covers certificates of pharmaceutical ...
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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 ...