Meeting EMA and FDA: Formal and Informal Pathways in Search of Alignment

Description: As Regulatory Affairs professionals we are familiar with the official meetings offered by the regulatory authorities EMA and FDA and, their importance for adequate drug development. An example of optional meetings offered during various time points in the product life cycle to support the resolution of scientific and regulatory issues is Scientific Advice (SA). These meetings in the US are typically referred to, for example as Type, A, B or C meetings. SA is not legally binding on authorities regarding any future marketing authorisation application for the medicine concerned. In this way, no pre-evaluation of the results of the studies or conclusions on benefit-risk assessments can be granted. And still, the increase in the number of scientific advice requests remains constant. Interestingly, not many Regulatory professionals are familiar with all types of interactions offered by both EMA and FDA. Rarely used authority interactions, namely EMA SME briefing meetings and FDA INTERACT or pre-breakthrough meetings, hold significant benefits for drug development, offering a unique opportunity to gain invaluable insights and enhance drug strategies in navigating the regulatory landscape. In this session, we will discuss the advantages and disadvantages, pros and cons of SA and informal meetings as well as best practices for the preparation of such meetings. A reflection from a 5-year Parallel (PSA) program review will be presented on whether alignment with EMA and FDA in a PSA meeting is an actually achievable goal. Besides identifying the best candidates and the most suitable development phase to apply, the most noteworthy findings will be emphasized. The authors hope their article fills the gap of the limited promotion and media coverage that may have resulted in an insufficient understanding of informal interactions and PSA subtleties, and consequently the limited uptake of these pathways by the sponsors.