Date: 12-Oct-2026 The European Medicines Agency (EMA) has published a concept paper discussing the need to develop a dedicated guideline for the clinical investigation of medicinal products intended for the…
Date: 08-Oct-2026 Intelligence Overview The U.S. Food and Drug Administration (USFDA) has published the Study Data Technical Conformance Guide, a technical specifications document supporting the submission of standardized study data…
09-Oct-2026 Intelligence Overview The U.S. Food and Drug Administration (USFDA) has issued the guidance document “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers” in October 2026.…
09-Oct-2026 Intelligence OverviewThe U.S. Food and Drug Administration (USFDA) has issued the revised guidance document “Questions and Answers on Biosimilar Development and the BPCI Act (Revision 4)” in October 2026.…
Date: 21 September 2026 The U.S. FDA has updated its regulations to support the use of innovative alternatives to traditional animal testing in the development of human drugs and biological…
The Central Drugs Standard Control Organisation (CDSCO), through its New Drugs Division, issued a circular dated 21 September 2026 highlighting the risks associated with the indiscriminate use of NSAIDs (painkillers)…
FDA Publishes Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances Authority: U.S. Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM)Document: Draft Guidance for Industry GFI #256BDate:…
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…