FDA Policy/General

Latest Federal Register Notices

Notice Corrected on 2 ANDA Withdrawals
7/9/2021 Federal Register notice: FDA is correcting a 12/2/2019 notice announcing the withdrawal of 21 ANDAs from multiple applicants. That notice included two ANDAs that had been previously withdrawn in an earlier notice. This notice corrects the error. To view the notice, click here.

Regulatory Review Period for Teva’s Ajovy
7/9/2021 Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Teva Pharmaceuticals’ Ajovy (fremanezumab-vfrm), indicated for preventing migraines in adults. The regulatory review period is 3,216 days, which includes 2,882 days that occurred during the testing phase and 334 days during the approval phase. To view the notice, click here.

HHS Withdraws Insulin Reimportation Notice
7/9/2021 Federal Register notice: HHS has withdrawn a 1/21 notice entitled “Requests for Proposals for Insulin Reimportation and Personal Prescription Drug Importation.” It is also withdrawing associated requests for proposals issued on its Web site. The department says it is not aware that any proposals were received in response to these notices. To view the notice, click here.

Guide on Unique Device Identifier Info
7/8/2021 Federal Register notice: FDA has made available a final guidance entitled Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). The document describes the requirements and recommendations for UDIs. To view the notice, click here.

Regulatory Review Period for Zephyr Valve Implant
7/7/2021 Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Pulmonx Corp.’s Zephyr Endobronchial Valve Implant, indicated for the bronchoscopic treatment of adult patients with hyperinflation associated with severe emphysema in regions of the lung that have little to no collateral ventilation. The regulatory review period is 5,744 days, which includes 5,565 days that occurred during the testing phase and 179 days during the approval phase. 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

Read more

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