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06

Mag

FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

The U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward.

In March 2020, the FDA announced that it was temporarily postponing all domestic and foreign routine surveillance facility inspections, while continuing mission critical inspections when possible. Beginning the week of July 20, 2020, the FDA began to work toward resuming prioritized domestic inspections using its COVID-19 Advisory Rating system. The report outlines inspections that the agency was unable to complete during the past year due to travel restrictions or inability to ensure the safety of our workforce or the workforces the agency regulates. The report also outlines the number of mission-critical inspections the agency completed during that time, such as inspections of facilities for which there was a drug shortage, inspections needed for the approval of novel drugs or drugs related to the potential treatment of COVID-19, support of pre-market and pre-license applications and response to foodborne disease outbreaks or other food safety risks such as undeclared allergens.

Among other things, the report highlights:

  • From March 2020 through March 2021, the FDA conducted a total of 821 mission-critical inspections, including 29 in foreign countries.
  • Additionally, the agency conducted a total of 777 prioritized domestic inspections since resumption of that work in July 2020.
  • Of the more than 13,500 applications for medical product approval or authorization received since March 2020, an estimated 68 applications have been delayed due to the inability to conduct inspections — and a majority of those are not deemed mission critical.

Additionally, the report outlines the FDA’s continued successful use of alternative tools and approaches where inspections were or are not currently feasible, including remote interactive evaluations (e.g., remote livestreaming video of operations, teleconferences or screen sharing), record requests and leveraging information from trusted regulatory partners. For example, over 1,300 record requests have been made to human and animal drug and biologic drug manufacturers that have led to a high level of on-time regulatory decision actions. [FDA]

07

Giu

EU Regulators On Forecasting Demand For Medicines In A Pandemic

EMA - Reflection paper on forecasting demand for medicinal products in the EU/EEA             ...

07

Giu

Svolta nel mercato dei farmaci in Cina, aziende straniere più tutelate

La riforma dei brevetti e l’introduzione di un nuovo regolamento sui dispositivi medicali fanno...

26

Mag

TGA Australia guidance details management of GMP compliance signals

Australia’s Therapeutic Goods Administration (TGA) has published guidance on the management...

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