Overview The European Medicines Agency (EMA) provides expert advice to support the development and evaluation of orphan medical devices, including guidance on orphan status and clinical requirements. Key Points Applies…
Date of Publication: 27-Feb-2026 INTELLIGENCE OVERVIEW:Agency: EMAThe European Medicines Agency (EMA) has published its latest Committee for Medicinal Products for Human Use (CHMP) meeting highlights, detailing positive opinions and key…
Date of Publication: 11-Feb-2026 INTELLIGENCE OVERVIEWAgency: US FDAThe FDA has issued a revised Draft Guidance (Revision 2) outlining the updated certification process for Designated Medical Gases (DMGs) under 21 CFR…
Date of Publication: 05-Feb-2026 INTELLIGENCE OVERVIEW The U.S. FDA has issued an Emergency Use Authorization (EUA) to support efforts against the New World screwworm outbreak affecting cattle. The authorization enables…
Date of Publication (Latest update): 05-Feb-2026 INTELLIGENCE OVERVIEW The European Medicines Agency (EMA) has published an updated data protection notice for EudraVigilance (Human), clarifying how personal data are processed within…
Date of Publication: 30-01-2026 INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA)Product: Incyte Biosciences Distribution B.V. - Zynyz (Retifanlimab)Indication: Squamous Cell Carcinoma of the Anal Canal (SCAC)Status: Positive CHMP opinion Industry Impact This decision…
Date of Publication: 01-Feb-2026 INTELLIGENCE OVERVIEW Agency: US FDA The U.S. Food and Drug Administration (FDA) has launched the PreCheck Pilot Program, an initiative designed to modernize regulatory oversight of sterile pharmaceutical…
Date of Publication: 29-Jan-2026 INTELLIGENCE OVERVIEW Agency: US FDA Regulatory authorities have issued updated guidance on Clinical Decision Support (CDS) software, clarifying how such tools are regulated when used to support healthcare…
Date of Publication: 02-02-2026 INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA) The European Medicines Agency (EMA) has published a reflection paper on the qualification of non-mutagenic impurities, providing scientific guidance on…
Date of Publication: 30-01-2026 INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA) The European Medicines Agency (EMA) has released a draft reflection paper outlining scientific principles for the qualification and control of…