As the COVID-19 pandemic continues, the FDA is racing to produce new and updated guidance to accelerate the development of coronavirus therapies while responding to the challenges the pandemic is creating for ongoing drug development. This week, the agency updated its guidance on conducting clinical trials during the COVID-19 emergency by adding content to the question-and-answer appendix. The additions discuss considerations for using alternate laboratories or imaging centers, holding trial participant visits via videoconference and conducting required postmarketing trials. The agency also updated the information about managing protocol deviations and amendments to ongoing trials, and about consulting with the FDA on administering investigational drug infusions at home rather than at the trial site.
The FDA also released two new COVID-19 guidances this week. The first guidance discusses general considerations for pre-investigational new drug application meeting requests and outlines a more efficient process for sponsors to receive agency feedback on their supporting data so they can begin clinical trials as soon as possible. In the second guidance, “COVID-19: Developing Drugs and Biological Products for Treatment or Prevention,” the FDA advises on later-stage trials intended to establish the safety and effectiveness for COVID-19 products. The guidance discusses considerations such as appropriate patient selection and trial design.
Recognizing the limited resources, possibility of a reduced workforce during a pandemic and likelihood of increased adverse events due to a widespread use of products intended to treat or prevent infections, the FDA issued a new guidance on how industry should handle postmarketing adverse event reporting for drugs, medical devices and dietary supplements during such times. The guidance is intended to help companies focus their limited resources on reports related to medical products indicated for the treatment or prevention of the pathogen causing the pandemic and to products presenting special concerns specified by the FDA. However, the guidance doesn’t address monitoring and reporting of adverse events imposed as a condition for products authorized for emergency use or as required for their investigational use.
The FDA is working with the CDC to develop a process to govern how and where it returns for on-site facility inspections. “We expect this to be a phased approach driven by scientific data,” FDA Commissioner Stephen Hahn said Monday. “Our priority and commitment are to first protect the health and well-being of not only our own highly skilled workforce and state contract inspectors, but also the health of workers in the important industries we regulate.” The FDA curtailed all routine foreign inspections March 10, later extending that to domestic inspections as well. In lieu of those inspections, the agency continues to use and implement additional alternative inspection tools and approaches, Hahn said.
The second phase of the FDA’s Purple Book update launched Monday, as the agency continues transforming its list of licensed biologics to a searchable, online database. With Phase 2, the database now consists of all licensed biologics regulated by the FDA’s Center for Drug Evaluation and Research (CDER), including those approved in new drug applications that were deemed to be biologic licenses March 23, 2020. Now that all its licensed biologics are in the database, CDER will no longer update its biologics list, the FDA said. However, the Center for Biologic Evaluation and Research will continue to update its list until the biologics it regulates are included in the Purple Book database.
The U.K. Medicines and Health Care Products Regulatory Agency (MHRA) said it is again taking applications for the agency’s chairperson, with a deadline of May 20. The chairperson will be tasked with leading the MHRA through the changes that will be imposed as a result of Brexit. The MHRA noted that the closing date for nominations has been amended or updated twice since the initial notification of Feb. 21.