Companies in India, China, and Europe continue to play an outsized role in manufacturing active pharmaceutical ingredients (API) used in products destined for the US market in terms of locations cited ...
The guidance document, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, was released on 26 June. It covers design, labeling and documentation that ...
The US Food and Drug Administration has listed more than half a dozen research areas related to generic drug development and authorization that it plans to prioritize in FY 2026. The agency@s ...
Pharmaceutical and medical device manufacturers should not assume that recent staff cuts at the US Food and Drug Administration (FDA) mean the agency will inspect less often and take fewer enforcement ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The European Commission has published a call for evidence on the medical device and in vitro diagnostic regulations (MDR/IVDR).
US-India Trade Deal : Generics Dance Goes On, Oil Prices To Be Watched (Pink Sheet) EU CHMP Opinions And MAA Updates (Pink Sheet) EU food agency sets 'safe' consumption level for hemp-derived CBD ...
The Central Drugs Standard Control Organization (CDSCO) has started a consultation on guidance about importing in vitro diagnostics (IVDs) into India.
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 ...
Device is intended for diagnosis, monitoring or treatment of a life-threatening or serious disease/condition. No generally acceptable alternative therapy exists. The risk from the disease or condition ...
Alongside the request for comments, HHS issued a separate notice identifying four documents for immediate recission, including a COVID-19 era notice on scarce or threatened materials subject to ...
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