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

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