FDA Says How It Will Handle Meetings, Applications During COVID-19

The FDA spelled out in a new guidance released yesterday how it will conduct formal meetings and deal with new drug applications during the COVID-19 pandemic.

The agency said it is conducting all formal meetings virtually and will continue accepting and granting new meeting requests as usual. It is also considering holding advisory committee meetings virtually.

Priority will be given to investigational new drug applications (INDs), new drug applications (NDAs) and biologics license applications (BLAs) for COVID-19 or certain other life-threatening conditions, the agency said.

It will also prioritize abbreviated new drug applications (ANDA) for products being investigated to prevent or treat COVID-19 but not labeled for this use, as well as drugs labeled to treat or prevent secondary conditions associated with COVID-19.

The agency said it might not be able to meet its user fee commitments to approval dates during the pandemic and will communicate with sponsors if it expects to miss a goal date.

The agency said it is continuing generic drug program application assessments despite the pandemic affecting activities such as inspections and travel. But it warned that it may need to shift resources to other activities.

Read the full guidance here: www.fdanews.com/05-27-20-Guidance.pdf. — Jordan Williams