At Best, FDA Will Carry Out Only Half Of Domestic Surveillance Inspections In FY 2021, Report Says
Agency vows to create Inspectional Affairs Council, modernize its regulatory oversight approach
A 5 May report from the US FDA says that even under the most favorable COVID-19 conditions the agency’s inspections of makers of medical and tobacco products will likely be cut in half this fiscal year. The FDA also announced it will launch an agency-wide Inspectional Affairs Council to “plan and coordinate inspectional activities.”
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The US FDA says in a report that its Inspectional Affairs Council will develop Remote Regulatory Assessment policies for all commodities the agency oversees. RRAs were launched by the FDA as a way to check on a firm’s regulatory compliance without sending an investigator on-site.
Top leaders from all commodity centers within the FDA will take part in a new Inspectional Affairs Council that’s being stood up by the agency’s Office of Regulatory Affairs. Acting commissioner Janet Woodcock will also play a role.
Enforcement Comeback? FDA Predicts 1,767% Increase In US Inspections In FY ’22, Matching Pre-Pandemic Levels
An FDA budget request released on 28 May estimates that domestic GMP inspections of US device makers will increase from a mere 75 in the current 2021 fiscal year to 1,400 in FY 2022. It also asks for an increase of $18.8m to pay for inspections of all commodities the agency oversees.