Date of Publication: 23-Jul-2026 INTELLIGENT OVERVIEWThe U.S. Food and Drug Administration (FDA) has issued an updated guidance document titled "Hemodialysis Blood Tubing Sets – Premarket Notification (510(k)) Submissions: Guidance for…
Date of Publication: 22-May-2026 INTELLIGENCE OVERVIEWAgency: Bhutan FDAThe Bhutan Food and Drug Authority (BFDA) has released a draft guideline on the Importation, Consignment Verification, and Lot Release of Medical Products…
Date of Publication: 20-May-2026 INTELLIGENCE OVERVIEWAgency: USFDAThe FDA has released the ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP) Guidance for Industry, introducing a standardized approach for structuring and electronically…
Date of Publication: 13-May-2026 INTELLIGENCE OVERVIEW:Agency: CDSCO (India)The Government of India has issued the Drugs (Second Amendment) Rules, 2026, introducing an important regulatory update by including Pregabalin under Schedule H1…
Date of Publication: 20-May-2026 INTELLIGENCE OVEERVIEWAgency: USFDAThe U.S. Food and Drug Administration (FDA) has issued a revised guidance titled “Assessing the Effects of Food on Drugs in INDs and NDAs…
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…