The U.S. FDA’s Pulmonary-Allergy Drugs Advisory Committee has a lot to discuss Nov. 17, but only one voting question: Does the evidence demonstrate that Merck & Co. Inc.’s gefapixant provides a clinically meaningful benefit to adults with refractory or unexplained chronic cough?
If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication.
The U.S. FDA’s Sept. 6 hearing of the Patient Engagement Advisory Committee (PEAC) tackled the question of health equity, a discussion that touched on several issues such as accessibility. One of the committee’s recommendations was that the FDA assist the Centers for Medicare & Medicaid Services (CMS) with the latter’s task of developing codes for payment, not the kind of task to which the FDA is typically assigned.
Dublin-based Medtronic plc. has invested considerable resources into its renal denervation program, but the company has not completed its regulatory journey for the U.S. market just yet. Medtronic failed to persuade an FDA advisory committee of the virtues of its Symplicity Spyral device due to inconsistent results from the two major studies presented at the hearing but vowed to keep working on the application despite the sustained headwinds.
The age of renal denervation as a treatment for hypertension may have finally arrived in the U.S. with the affirmative U.S. FDA advisory vote for the Paradise system for renal denervation by Recor Medical Inc., of Palo Alto, Calif. The 12-member advisory committee vote unanimously that the data suggested the ultrasound-based device was safe and voted 8-3 in support of the Paradise’s efficacy, an outcome that the agency may find difficult to refute, given the large public health impact of hypertension in the U.S.
Patients with ophthalmic disease use eyedrop containers and eyecups millions of times a year, but these two devices have been treated as one device type and informally regulated as class II devices up to now. A U.S. FDA advisory committee recommended a class I designation for these products, which will relieve some of the burden on manufacturers, but the panel also endorsed that these two types of products be split into two separate product codes, which would greatly facilitate adverse event reporting.
The U.S. FDA recently convened an advisory committee to address accuracy issues with pulse oximetry devices, with a significant focus on skin pigmentation as a source of noise in the results generated by these class II devices. However, a number of other factors, including obesity and finger size/diameter, also cloud the values generated by pulse oximeters, all of which combine into a large set of variables that premarket studies may have to address before the FDA will issue new marketing authorizations.
The U.S. FDA held a two-day advisory hearing in the last week of October 2022 to address some lingering regulatory questions, including the question of whether therapeutic nail prostheses should be a class I device. The potentially more dramatic shift, however, would be the application of a class III risk designation to tissue expanders used in breast surgery.
The U.S. COVID-19 vaccine program is at risk of “booster fatigue,” which will undermine public confidence in the vaccines, several members of the CDC’s Advisory Committee on Immunization Practices (ACIP) said April 20 as they met to discuss the future of the vaccines. Rather than relying on boosters, “we need to use our expertise to advocate for something that’s better,” something that resolves the ill effects of COVID-19, whether it’s mild or severe, said Lynn Bahta, an immunization program clinical consultant for the Minnesota Department of Health.
