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
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
