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Newsletter - July 28, 2022

FDA Limits Extensions on CRL Responses for ANDA

Applicants must respond to a Complete Response Letter (CRL) within 1 year unless an extension is requested prior to the expiration of the 1-year period. So far, FDA liberally granted extensions for the CRL responses, but not for long. In a new guidance document describing a previously unenforced policy, FDA announced that it would limit...Read More

FDA Formalizes Remote Audit Practices via a New Guidance Document

FDA’s practice of remote inspections, necessitated by the pandemic, is being made permanent via a new Guidance Document released this week. Remote inspections are known by many synonymous terms such as Remote Regulatory Assessment (RRA), remote interactive evaluations, remote record review, etc...Read More

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