Date of Publication: 09-Mar-2026 INTELLIGENCE OVERVIEWAgency: USFDAThe U.S. Food and Drug Administration (FDA) has released Revision 4 of the draft guidance titled “New and Revised Draft Q&As on Biosimilar Development…
Date of Publication: 03-Mar-2026 INTELLIGENCE OVERVIEWAgency: USFDAThe U.S. Food and Drug Administration (FDA) has released a draft guidance titled “Responding to FDA Form 483 Observations at the Conclusion of a…
Date of Publication: 04-Mar-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has released a draft guidance on the conduct of clinical trials during public health emergencies, published on 27 February…
Date of Publication: 04-Mar-2026 INTELLIGENCE OVERVIEWAgency: Health Sciences Authority - SingaporeThe Health Sciences Authority (HSA), Singapore has released an updated guidance document titled “SG-HSA eCTD Specification and Guidance for Use…
Date of Publication: 02-Mar-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA), through its Committee for Medicinal Products for Human Use (CHMP), adopted a draft concept paper (EMA/CHMP/30023/2026) for public consultation…
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: 27-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAApplicant: Sanofi Winthrop IndustrieProduct: Acoziborole WinthropThe European Medicines Agency (EMA) has highlighted a significant advancement with its update on a new single-dose oral treatment.…
Date of Publication: 23-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has published an updated list of reference documents supporting electronic safety reporting to the EudraVigilance system. This resource outlines…
Date of Publication: 20-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA), through its Committee for Veterinary Medicinal Products (CVMP), has released a draft guideline outlining the quality requirements for mRNA…
Date of Publication: 20-Feb-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has released Revision 3 of its guideline on risk management requirements for elemental impurities in veterinary medicinal products. This…