The US Food and Drug Administration (FDA) has issued final guidance in the form of a question-and-answer guide to provide answers to frequently asked questions about regulatory and policy issues related to drug development for the duration of the COVID-19 public health emergency. The guidance document is being implemented immediately, but it remains subject to comment in accordance with the FDA’s good guidance practices.

The guidance document, Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications: Questions and Answers, was issued to provide answers to frequently asked questions concerning certain aspects of sponsor requests for formal meetings with the industry and the FDA, user-fee applications goals and timelines, and prioritization of drug and biological application reviews during the COVID-19 public health emergency.

The guidance specifies that the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are using technology to host virtual meetings rather than in-person meetings with industry during the COVID-19 public health emergency. At this time, all meetings will be held virtually. Many Prescription Drug User Fee Act (PDUFA) or Biosimilar User Fee Act (BsUFA) meetings that were previously scheduled as in-person meetings have been converted to virtual meetings to be held at the same dates and times as the originally scheduled meetings. The FDA says it is continuing to accept new meeting requests. To ensure that virtual meetings go as smoothly as possible, the FDA is disseminating best practices and providing training to FDA staff for meeting management.

In addition, the FDA says that it is continuing to evaluate the feasibility of conducting advisory committee meetings virtually. The FDA says that the review divisions will work with sponsors and applicants for specific applications that could potentially be affected and will discuss options for pursuing virtual meetings.

The FDA says the New Drugs Program in CDER and the Biologics Program in CBER are experiencing considerable increases in COVID-19-related work, which is requiring shifting of staff resources to help with these activities. With many staff members working on COVID-19 activities, the agency says it may be possible that it will not be able to sustain its level of performance with respect to the performance goals and associated timelines in its user-fee commitments. It says that it anticipates that the New Drugs Program and the Biologics Program may need to allocate resources to focus on certain activities. In terms of priority, the FDA says it intends to focus resources on investigational new drug applications, new drug applications, and biologics license applications for drugs or biologics related to COVID-19 or certain other life-threatening conditions.

With respect to generics, the FDA says that the although the COVID-19 public health emergency has affected some activities, such as travel and inspections, it is continuing its Generic Drug Program application assessment activities.

If generic-drug applicants experience a missed goal date under the Generic Drug User Fee Act (GDUFA), the FDA says they should reach out to the appropriate project manager. For unapproved abbreviated new drug applications (ANDAs), the appropriate project manager is the regulatory project manager (RPM). For supplements to ANDAs, applicants should contact the appropriate discipline project manager if the supplement pertains to one discipline, or the RPM for multidisciplinary supplements.

Source: US Food and Drug Administration