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 ...

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 ...

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 ...

The Central Drugs Standard Control Organization (CDSCO) has started a consultation on guidance about importing in vitro diagnostics (IVDs) into India.

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 ...

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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 ...