INTELLIGENCE OVERVIEW The U.S. FDA has issued guidance on Computer Software Assurance (CSA) for Production and Quality Systems, introducing a risk-based, critical-thinking approach to software validation in the pharmaceutical and…
Date of Publication: 05-Feb-2026 INTELLIGENCE OVERVIEW The U.S. Food and Drug Administration (FDA) has announced its intent to take regulatory action against non-FDA-approved GLP-1 drug products, including certain compounded versions…
Date of Publication: 05-Feb-2026 (Official Gazette) INTELLIGENCE OVERVIEW Agency: Ministry of Health & Family Welfare – India/ The Gazette of India The Ministry of Health and Family Welfare (MoHFW), India,…
Date of Publication: 02-Feb-2026 INTELLIGENCE OVERVIEW Agency: Central Drugs Standard Control Organization - India/ Ministry of Health & Family Welfare - India The Ministry of Health and Family Welfare (MoHFW),…
Date of Publication (Latest update): 05-Feb-2026 INTELLIGENCE OVERVIEW The European Medicines Agency (EMA) has published an updated data protection notice for EudraVigilance (Human), clarifying how personal data are processed within…
Date of Publication: 05-Feb-2026 INTELLIGENCE OVERVIEW The EMA’s list of new human medicines under evaluation (February 2026) offers an early view into the next wave of therapies moving toward EU…
Date of Publication: 30-01-2026 INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA)Product: Neurocrine Netherlands B.V. - Efmody (Hydrocortisone)Indication: adrenal insufficiency (AI) Status: Positive CHMP opinion Industry Impact This decision highlights important regulatory and development…
Date of Publication: 30-01-2026 INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA)Product: AstraZeneca AB. - Imfinzi (Durvalumab)Indication: Gastric or Gastro-oesophageal Junction Adenocarcinoma (GC/GEJC)Status: Positive CHMP opinion Industry Impact This decision reflects key regulatory and…
Date of Publication: 30-01-2026 INTELLIGENCE OVERVIEW Agency: European Medicines Agency (EMA)Product: Incyte Biosciences Distribution B.V. - Zynyz (Retifanlimab)Indication: Squamous Cell Carcinoma of the Anal Canal (SCAC)Status: Positive CHMP opinion Industry Impact This decision…
Date of Publication: 01-Feb-2026 INTELLIGENCE OVERVIEW Agency: US FDA The U.S. Food and Drug Administration (FDA) has launched the PreCheck Pilot Program, an initiative designed to modernize regulatory oversight of sterile pharmaceutical…