Regulierte KI in der Pharma braucht präzise Einordnung.

EMA – Inspections (GMP/GCP) 28.10.2026

INSPECTION Notice to sponsors on validation and qualification of computerised systems used in clinical trials Notice to sponsors on validation and qualification of computerised systems used in clinical trials Zur Originalmeldung

PIC/S 28.10.2026

Meldung Adoption and Entry into force of PIC/S Recommendation (PI 058-1) - Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products (2022) Geneva, 28 October 2026 PIC/S has published the Recommendation PI 058-1 - Interpretation of the most important changes in the Annex 1 on the Manufacture of Sterile Products (2022). This document was prepared by a… Zur Originalmeldung

BfArM – Pressemitteilungen 28.10.2026

Meldung BfArM setzt auf Digitalisierung und Gesundheitsdaten: Dr. Stefanie Weber wird neue Vizepräsidentin Pressemitteilung Nr. 09/26 vom 28.10.2026 Zur Originalmeldung

US Federal Register – FDA (Rules/Notices/Guidance) 28.10.2026

CONSULTATION Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management; Draft Guidance for Industry; Availability The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management."… Zur Originalmeldung

US Federal Register – FDA (Rules/Notices/Guidance) 28.10.2026

CONSULTATION Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Color Additive Certification The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act… Zur Originalmeldung

US Federal Register – FDA (Rules/Notices/Guidance) 28.10.2026

CONSULTATION Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Rapid Response Surveys The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal… Zur Originalmeldung

US Federal Register – FDA (Rules/Notices/Guidance) 28.10.2026

Meldung Issuance of Priority Review Voucher; Rare Pediatric Disease Product; EMCITATE (Tiratricol) The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act)… Zur Originalmeldung

US Federal Register – FDA (Rules/Notices/Guidance) 28.10.2026

Meldung Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ATEBRIOZ (Zilurgisertib) The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act)… Zur Originalmeldung

US Federal Register – FDA (Rules/Notices/Guidance) 28.10.2026

Meldung Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure (MCM) Priority Review Voucher; Bixlenvo (Bictegravir and Lenacapavir) The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a material threat MCM priority review voucher. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the 21st… Zur Originalmeldung