FDA Policy/General

Latest Federal Register Notices

Comments Extended on Carbadox Carcinogenic Concern
03/30/2022 Federal Register notice: FDA is extending the comment period of a 1/13 Federal Register notice seeking input on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox. Comments now can be submitted until 6/10. To view the notice, click here.

Info Collection on Clinical Investigator Disclosures
03/29/2022 Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Financial Disclosure by Clinical Investigators” (OMB Control Number 0910-0396). FDA’s regulations require that applicants submitting an application that relies on clinical studies must submit a complete list of clinical investigators who participated in a covered clinical study, and must either certify to the absence of certain financial arrangements with clinical investigators (Form FDA 3454) or disclose to FDA the nature of those arrangements and the steps taken by the applicant or sponsor to minimize the potential for bias (Form FDA 3455). To view the notice, click here.

Device Rule Reduces Paper Copy Submissions
03/28/2022 Federal Register final rule: FDA is amending the medical device regulations to update mailing address information and to reduce (from three to one) the number of copies of certain documents that need to be submitted to FDA. The rule does not impose any new regulatory requirements as it is editorial related and intended to improve the accuracy of the agency’s regulations by removing a submission requirement that is no longer necessary. To view the notice, click here.

Animal Drug Regs Amended for Approvals
03/28/2022 Federal Register final rule: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during 10/2021, 11/2021 and 12/2021. FDA is also making available the basis of approval and environmental review documents, where applicable. Additionally, the animal drug regulations are being amended to improve their accuracy. To view the notice, click here.

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