Through this rule, FDA is updating the standards for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects. In this rule, FDA is amending the regulations for PMA applications, HDE applications, IDE applications, and premarket notification submissions. As part of this rule, FDA also is amending the IDE regulations and the premarket notification regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States.
- Applying in parallel with an EU marketing authorisation application
- Notified bodies’ audits performed in the context of quality management system assessment
- FORMAÇÕES 2021 : CREDITAÇÕES PELA ORDEM DOS FARMACÊUTICOS.
- Calendário de formações 2021
- IMPLEMENTATION ROLLING PLAN Regulation (EU) 2017/745 and Regulation (EU) 2017/746. Update dec 2020
- Register medical devices to place on the market
- 14ª Edição da formação sobre as BPD: “Uma revisão abrangente da temática ,que combina a legislação com casos práticos”
- Joint strategy sets direction for EMA and EU medicines regulatory agencies to 2025