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 ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US NIH shut out hundreds of young scientists from funding to start their own labs (STAT) Driven by ...
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 ...
In a letter sent last week, the US Food and Drug Administration (FDA) said that a TV ad for Novo Nordisk@s Wegovy (semaglutide) tablets misleads consumers into thinking the pill is better than other ...
The Central Drugs Standard Control Organization (CDSCO) has started a consultation on guidance about importing in vitro diagnostics (IVDs) into India.
The European Commission has published a call for evidence on the medical device and in vitro diagnostic regulations (MDR/IVDR).
Understand how labeling decisions fundamentally shape your promotional strategy. This event will tackle the common challenges of translating complex regulatory language into compelling yet compliant ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
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 International Council on Harmonisation (ICH) announced the adoption of its M15 guideline, which aims to harmonize general principles and best practices for utilizing model-informed drug ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results