Drugs

ANDA Guide on Failing to Respond to CRLs

FDA has released a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe. The document is intended to assist ANDA applicants in responding to complete response letters (CRLs) from FDA. It provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a CRL, as well as the actions that FDA may take if the applicant fails to respond to the letter.

Under the guidance, an ANDA applicant after receiving a CRL must (1) resubmit its ANDA (i.e., submit all materials needed to fully address all deficiencies identified in the CRL), (2) withdraw its ANDA, or (3) request the opportunity for a hearing. “If an applicant fails to take one of these three actions within one year after issuance of a CRL, FDA may consider this failure to be a request to withdraw the ANDA unless the applicant has requested an extension of time to address all deficiencies identified in the CRL,” the agency says. “Under the Generic Drug User Fee Amendments program, FDA has seen a steady increase of ANDAs pending with industry for more than a year.”

Over the years, FDA says it has liberally granted requests for multiple extensions that have slowed the ANDA assessment process. “Lengthy response times because of multiple extensions, which can result in applicants submitting an amendment addressing deficiencies years after the initial assessment of the ANDA and issuance of the CRL, are disruptive to the assessment process and can create additional assessment cycles,” it says. If the submission extends for too long, it risks becoming obsolete because of changes such as new or revised United States Pharmacopeia requirements, labeling changes to the reference listed drug, or other events such as a facility evaluation becoming outdated, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome