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Public Policy Newsletter Article

Guidance provides considerations to assist sponsors in preparing pre-investigational new drug application (pre- IND) meeting requests for COVID-19 related drugs

FDA Releases New COVID-19 Guidances and Updates

  • 2020-05-14T19:00:00.000+0000
  • Washington DC
  • Author: Brittany Blocker

This week, the Food and Drug Administration released two new COVID-19 guidances and an update to the conducting clinical trial guidance.

COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products

This guidance provides general considerations to assist sponsors in preparing pre-investigational new drug application (pre- IND) meeting requests for COVID-19 related drugs for the duration of the COVID-19 public health emergency. FDA recommends that sponsors initiate all drug development interactions for COVID-19 related drugs through IND meeting requests.

FDA explains that is consolidating its pre-IND meeting request and package development process into a single step during the COVID-19 outbreak. In most cases, FDA will review and respond to pre-IND meeting requests in writing only and requests will be prioritized based on completeness of the submission and scientific merit. Sponsors with active INDs for drugs currently in development or those that have submitted pre-IND meeting requests or INDs to repurpose an already-approved drug for COVID-19 should submit a new pre-IND meeting request cross-referencing any existing applications for the product instead of amending an existing submission. Sponsors should begin discussions about investigational products for COVID-19 through pre-IND meeting requests as opposed to pre-emergency use authorization (pre-EUA) requests.

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

This guidance describes FDA’s current recommendations regarding phase 2 or phase 3 trials for drugs under development to treat or prevent COVID-19. It focuses on the development of drugs with direct antiviral activity or immunomodulatory activity. It outlines considerations including population, trial design, efficacy endpoints, safety considerations, and statistical considerations for such clinical trials.

FDA strongly recommends that drugs to treat or prevent COVID-19 be evaluated in randomized, placebo-controlled, double-blind clinical trials using a superiority design, and that standard of care should be applied in all treatment arms. Sponsors should address anticipated off-label use of any other drugs, devices, or interventions that might be used to manage COVID-19. FDA also allows for decentralized or platform clinical trials under certain circumstances.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

FDA clarifies in the updated guidance that sponsors should include protocol deviations and amendments to ongoing trials in final study reports and may also be included in annual reports. For investigational device exemption (IDE), the agency explains that the requirements to get FDA approval before making changes to an investigational plan do not apply to changes made to protect the life or physical well-being of a subject in an emergency, including study-wide changes, but such deviations must be working days.

FDA now expects sponsors to perform risk assessments when considering alternative arrangements for administering investigational products. The risk assessment should consider the nature of the investigational product and the potential risk to both the trial participants and the health care providers responsible for administering the product at the alternative site. After conducting a risk assessment, sponsors should consider whether consulting the appropriate FDA review division is necessary.

The updated guidance also includes three new questions and answers on alternate laboratory or imaging centers, remote participant visits through video conferencing, and post-marketing requirements for drugs, biologics, and medical devices. FDA says that sponsors should evaluate whether it is feasible to use alternative laboratories or imaging centers for protocol assessments as participants may not be able to visit the sites specified in the protocol due to disruptions caused by the COVID-19 pandemic. On video conferencing, the agency recommends that investigators and study personnel should be trained on using telemedicine and that procedures are put in place to protect participant privacy and confirm the investigators’ and participants’ identities. Lastly, the agency explains that the guidance applies to post-marketing clinical trials, including post-marketing requirements for drugs and biologics.