
- Applied Clinical Trials-09-01-2020
- Volume 29
- Issue 9
FDA May Delay Approval of Drugs Where Necessary Inspection is Not Feasible
FDA to resume “prioritized domestic inspections” for certain regulated products put on hold by COVID-19.
FDA announced recently that it planned to resume “prioritized domestic inspections” for certain regulated products that had been put on hold by COVID-19 since March. The agency also would
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Breakthrough therapies and regenerative medicine advanced therapies may gain approval even without a desired inspection. This policy also applies to other mission critical therapies used to diagnose, treat, or prevent a serious disease where no treatment alternative is available.
However, if an application involves a less critical medicine, and FDA has concerns about the adequacy of the facility but cannot conduct a site visit before the application’s “action date,” then FDA will issue a complete response letter that explains the reasons for delaying approval.
The agency will try to avoid such situations by utilizing other methods to access needed information on a manufacturing operation without an actual site visit. FDA will review earlier inspection reports, request records and information from the applicant and from the facility, and seek to obtain inspection reports from other trusted foreign regulatory partners. And for drugs made overseas where inspections continue to remain on hold, the agency will review product quality through sampling and testing at border control sites.
Similar assessments will apply to Bioresearch Monitoring (BIMO) surveillance of research sites, conducted to ensure that investigators follow policies to protect research subjects and to ensure the accuracy of clinical trial data. Here, FDA will continue to follow risk-based approaches that consider the nature of the application and site-specific factors.
The new guidance also provides flexibility for manufacturers looking to make changes in a facility or production process for an approved product affected by supply chain disruptions due to the pandemic. FDA will expedite such requests for drugs and biologics used in treating COVID-19 patients and for critical products in shortage situations. This will involve weighing the impact of post-approval changes and a firm’s efforts to mitigate the risk to product quality associated with a change. For critical products, FDA may permit a manufacturer to use a lower reporting category to facilitate the change and avoid C review and inspection of the changes.
Jill Wechsler is Applied Clinical Trials' Washington Editor
Articles in this issue
about 5 years ago
News Notesabout 5 years ago
Innovative Clinical Trial Designs Emerge from Pandemicabout 5 years ago
Applying Pre-Pandemic Benchmarks to Assess Future Speed Strategiesabout 5 years ago
Silver Linings of Post-Pandemic Trial Disruptionabout 5 years ago
Debate Accelerates Over Who Gets COVID Vaccine Firstabout 5 years ago
FDA’s ‘Gold Standard’ Critical for Biopharma R&Dabout 5 years ago
Decentralized Trials: Opening New Opportunities in Clinical Researchabout 5 years ago
The Rise of FSP Outsourcing in Drug Developmentabout 5 years ago
Trial Innovation Beyond the COVID-19 Pandemicabout 5 years ago
Small Biopharma and CROs: Seeking Stronger SynergiesNewsletter
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