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Firms That Get Complete Response Letters Might Get Inspected By US FDA Six Months After Replies

Pandemic Continuing to Make Travel Difficult For Inspectors

 
• By Joanne S. Eglovitch

While COVID-19 continues to wreak havoc on FDA's ability to perform onsite preapproval inspections, new guidance offers some clarity, but the news isn't great for ANDA holders.

US FDA entrance sign
FDA Sheds Some Light On When Firms Can Expect To Be Inspected Again

The US Food and Drug Administration has announced that while COVID-19 travel restrictions will continue to delay on-site preapproval inspections, sponsors of new drugs that have received a complete response letter can expect to be inspected within six months of responding to the CRL.

The announcement was made in a 21 December guidance which aimed to shed some light on when manufacturers can...

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