FDA Policy/General

Latest Federal Register Notices

FDA Withdraws Approval for 216 ANDAs
10/22/2021 Federal Register notice: FDA has withdrawn the approval of 216 ANDAs from multiple holders because they repeatedly failed to submit required annual reports to the agency. Previousy, FDA published a notice offering an opportunity for a hearing on proposal to withdraw approval, and the holders of the 216 applications did not respond. To view the notice, click here.

Guide on Submitting Real-world Data
10/22/2021 Federal Register notice: FDA has made available a draft guidance entitled Data Standards for Drug and Biological Product Submissions Containing Real-World Data. The document provides recommendations to sponsors when submitting study data derived from real-world data sources in applicable regulatory submissions using standards specified in the Data Standards Catalog. To view the notice, click here.

Regulatory Review Determined for Orion’s Nubeqa
10/21/2021 Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Orion Corp.’s Nubeqa (darolutamide), indicated for treating patients with non-metastatic castration-resistant prostate cancer. The regulatory review period is 2,576 days, which includes 2,420 days that occurred during the testing phase and 156 days during the approval phase. To view the notice, click here.

OTC Hearing Aids Proposed Rule
10/20/2021 Federal Register proposed rule: FDA is proposing to establish a regulatory category for over-the-counter (OTC) hearing aids and to make related amendments to update the regulatory framework for such devices. Specifically, it seeks to define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with a new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from federal preemption that would become obsolete as a result of changes to the hearing aid requirements. 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