Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

On 28 September 2020 the FDA announced the availability of the draft guidance for industry.

This guidance is intended to assist applicants of abbreviated new drug applications (ANDAs), which were submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), in responding to complete response letters (CRLs) from the FDA. As described in regulation, ANDA applicants are required to take action after receiving a CRL. This guidance provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a CRL, as well as the actions that the FDA may take if the applicant fails to respond to that CRL.

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