FDA is issuing this guidance to allow manufacturers to provide user manuals accompanying electronic products in either paper or electronic form. This is done to recognize that electronic media are now being widely used to provide instruction, while at the same time reducing paper consumption, increasing accessibility and providing rapid means for editing and updating content.
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- FDA draft guidance :“New Clinical Investigation Exclusivity: 3-Year Exclusivity for Drug Products – Questions and Answers.”
- webinar INTELIGÊNCIA ARTIFICIAL NA INDÚSTRIA FARMACÊUTICA :IA EM CONTEXTO GxP (Annex 11, 22, EU AI Act , GAMP®)
- GESTÃO da DISPONIBILIDADE do MEDICAMENTO: “Formação muito útil !
- IMDRF Playbook for Medical Device Regulatory Reliance Programs
- IMDRF Considerations for the selection of IMDRF Adverse Event Terminology
- Concept paper on the revision of the guidelines on Good Manufacturing Practice for medicinal products – Annex 15 – Qualification and Validation
- FDA Draft Guidance General Considerations for Patient Preference Studies February 2026
- Open consultation: Medical devices regulations: targeted consultation on the indefinite recognition of CE marked devices

