Date of Publication: 06-May-2026 INTELLIGENCE OVERVIEWAgency: USFDAThe U.S. Food and Drug Administration (FDA) has released a new technical guidance document titled , providing industry recommendations for the standardized submission of…
Date of Publication: 07-May-2026 INTELLIGENCE OVERVIEWAgency: USFDAThe U.S. Food and Drug Administration (FDA) has issued its final guidance titled “Patient-Matched Guides for Orthopedic Implants.” The document provides recommendations for manufacturers…
Date of Publication: 14-Apr-2026 INTELLIGENCE OVERVIEWThe European Medicines Agency (EMA) has released an updated guidance (Revision 19, April 2026) on the procedural advice for orphan medicinal product designation, offering a…
Date of Publication: 10-Apr-2026 INTELLIGENCE OVERVIEWAgency: Official Gazette of India/MHFWThe Ministry of Health and Family Welfare has published a draft amendment to the Medical Devices Rules, 2017 on 10 April…
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…
INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency (EMA) has released Revision 2 of its guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg), adopted by…
Date of Publication: 30-Mar-2026 INTELLIGENCE OVERVIEWAgency: USFDAThe U.S. FDA has released guidance highlighting how Voluntary Patient Preference Information (PPI) can support regulatory decision-making for medical devices across the total product…
Date of Publication: 27-Mar-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency has published updated procedural advice for users of the centralised procedure, providing important guidance for marketing authorisation holders (MAHs) managing…
Date of Publication: 26-Mar-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency has published a new Clinical Trial Information System (CTIS) Sponsor Frequently Asked Questions (FAQs) document to help sponsors navigate common…
Date of Publication: 13-Mar-2026 INTELLIGENCE OVERVIEWAgency: EMAThe European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recently concluded a safety review regarding Ixchiq, a live attenuated vaccine used to prevent…