The European Medicines Agency recently launched a public consultation on a draft guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol. EIPG has reviewed the document and, following feedback from its members, has submitted its comments to the EMA.
News from EIPG
- Development of therapeutic protein biosimilars May 22, 2019
- Draft ICH guideline E8 (R1) on general considerations for clinical studies May 14, 2019
- Considerations in demonstrating interchangeability with a reference product May 12, 2019
- Determining whether to submit an ANDA or a 505(b)(2) application May 12, 2019
- Maximal usage trials for topically applied active ingredients in OTC monographs May 12, 2019