From February 13, FDA In-Person Session To Start Barring Few

FDA has recently announced that it is going to restart its in-person meetings that are face-to-face beginning February 13 with industry sponsors of biologics and drugs. This step is taken after a shift took place toward all virtual meetings during the COVID-19 pandemic for almost three years.

That said, the agency also defined that it has revised the definition of such formal meetings to include both virtual as well as in-person elements, thereby utilising the IT platforms that aid in both audio as well as video interaction. The FDA says that the face-to-face between themselves and the industry is going to be a combination of both, in-person as well as virtual, with cameras in place.

The redefining of in-person meetings was agreed upon in the recently upgraded user-free agreements for drugs as well as biosimilars. The FDA is also looking to apply a similar process in formal meetings that involve over-the-counter medicines, although the new user fee agreement does not have this particular policy in place. As of now, the agency will limit the face-to-face sessions with hybrid components to encourage Type A meetings, Type X meetings, and Biosimilar Product Development Type 1 sessions. The other meeting types are going to be completely virtual, without any in-person element in them.

The FDA remarks that it is in the process of upgrading the guidance documents when it comes to formal meetings so as to include the revised definition and is also highlighting the new meeting policy across its website in order to help reduce the uncertainties for all the parties involved. This dual approach to in-person meetings is a reflection of the hybrid workplace format existing in the Centers for Drug Evaluation and Research as well as the Centers for Biologics Evaluation and Research. The agency is also upgrading its conference rooms over there in phases in order to better take care of hybrid meetings.

So as to better manage the in-person element of the hybrid sessions, the FDA also plans to limit the number of people present in the room to those with primary speaking roles, and it also encourages the entire industry to do so. Other staffers across the parties can join the session online. As FDA starts putting in place more conference rooms, it also plans to conduct other types of meetings when it comes to in-person scheduling like milestone meetings for Type A and Type B, Type X ad Type Y as well as BPD Type 1 and Type 2. Eventually, with time, all the FTF formal meetings may fall under the gamut of an in-person format.