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…
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: 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INTELLIGENCE OVERVIEWAgency: USFDAThe U.S. Food and Drug Administration (FDA) has released Revision 4 of the draft guidance titled “New and Revised Draft Q&As on Biosimilar Development…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Publication: 03-Mar-2026 INTELLIGENCE OVERVIEWAgency: USFDAThe U.S. Food and Drug Administration (FDA) has released a draft guidance titled “Responding to FDA Form 483 Observations at the Conclusion of a…