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# FDA Updates Hill on Covid Therapies, Inspections
- URL: https://www.fdaweb.com/fda-updates-hill-on-covid-therapies-inspections/
- Published: 2021-11-04T12:00:00.000Z
- Updated: 2026-09-14T17:21:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150522

Covid-19 has led to an unprecedented number of new product submissions to FDA to help combat it. To date, there are more than 660 drug development programs in the planning stages and the agency has reviewed more than 470 trials of potential therapies, according to acting commissioner **Janet Woodcock**. In her [11/4 testimony](https://www.fda.gov/news-events/congressional-testimony/next-steps-road-ahead-covid-19-response-11042021?ref=fdaweb.com) to the Senate Health Education Labor & Pension Committee, Woodcock said the submissions include antivirals, immunomodulators, neutralizing antibodies, cell and gene therapies, and combinations of these products. “The diversity of therapeutic approaches being investigated is important because it rapidly expands our understanding of the effect of different categories of potential treatments,” she said.

Since the beginning of Covid, FDA has been handling therapeutic submissions under its Coronavirus Treatment Acceleration Program (CTAP). “The agency has supported the program by reassigning staff and working continuously to review requests from companies, scientists, and doctors who are working to develop therapies,” she said in her testimony. Under CTAP, FDA is using every available authority and regulatory flexibility to speed products to market. To date, FDA has approved one drug to treat Covid-19 and eleven therapeutics are currently authorized for emergency use, she noted.

On the inspection and compliance front, Woodcock said that since the pandemic’s beginning, FDA has received and destroyed almost 77,000 products, totaling over 13,932,173 capsules, tablets, and pieces of unapproved drugs. “Since March 2020, FDA has maintained the same level of screening for imported products as pre-pandemic and refused approximately 102,654 lines of imported, violative medical products,” she said.

Woodcock’s testimony also highlighted FDA’s “successful use of alternative tools and approaches where inspections are not feasible, including remote regulatory assessments (e.g. requests to regulated establishments to remotely view records) and interactive evaluations that include remote livestreaming video of operations, teleconferences, or screen sharing, and leveraging information from trusted regulatory partners.” For example, the agency made over 1,300 requests to medical product manufacturers to remotely view records to help it take on-time regulatory decision actions. “In addition, since March 2020, FDA has added products from 23 firms to import alerts, based on records requests in advance or in lieu of inspection that FDA submitted pursuant to section 704(a)(4) of the FD&C Act,” she wrote.  

Woodcock also noted that FDA’s bioresearch monitoring program staff has conducted more than 130 remote regulatory assessments that were directly used in application decisions. “The new tool was incentivized for and supported by industry and continues to provide the agency with valuable information to assist with risk-based targeting for inspections,” she said. “FDA recognizes that remote approaches do not replace inspections, and that there are situations where only an inspection is appropriate based on risk and history of compliance with FDA regulations.” Additionally, Woodcock said 68 application submissions during Covid had been delayed due to the inability to conduct inspections. To date, the agency has now rendered decisions on nearly half of these 68 applications. 

In recognition of the new remote tools FDA has at its disposal, in July the agency launched a multi-year modernization effort to transform its data enterprise platforms and cross-program interoperability infrastructure to better support innovation related to its regulatory oversight role. “This includes adopting technology to support regulatory assessments to improve our remote receipt, review, and analysis of industry data and records, and improve remote interactions with industry entities to be easier, more efficient, more consistent, and more secure,” according to Woodcock’s testimony. “This modernization effort includes a review of inspectional approaches using next-generation assessment technologies and improvements.”