Drugs

Pandemic CRL Response Timelines

FDA has published a guidance, Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment is Needed During the Covid-19 Public Health Emergency, with information on review timelines the agency will use during the Covid-19 public health emergency. The document applies to applicant responses to complete response letters when a facility assessment is necessary before FDA can take action on a marketing application for:

amendments to original and supplemental ANDAs submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FFDCA);
resubmissions of original and supplemental BLAs submitted under sections 351(a) and (k) of the Public Health Services Act; and
resubmission of original and supplemental NDAs submitted under sections 505(b)(1) and (2) of the FFDCA.

Specifically, the guidance explains how FDA will determine review timelines following the issuance of a complete response letter when a facility assessment is necessary for the agency’s regulatory decision on an original or supplemental application. The guidance applies to inspections of manufacturing facilities and also to bioresearch monitoring program sites conducting clinical, analytical, and nonclinical studies.

The policy will remain in effect only for the duration of the pandemic public health emergency declared by HHS.

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