Devices
FDA has granted Carthera a breakthrough device designation for its SonoCloud-9 system, a device that uses low intensity pulsed ultrasound to temporarily disrupt the blood-brain barrier (BBB) to allow higher brain exposure to therapeutic compounds. “By using SonoCloud, the therapeutic efficacy of new and existing therapies can be
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Protection of Human Subjects; Informed Consent; and Institutional Review Boards — 21 CFR Parts 50 and 56” (OMB Control Number 0910-0130). To view the notice, click here.
Drugs
AbbVie has submitted an sNDA to FDA for a new indication for its Qulipta (atogepant) as a preventive treatment for chronic migraine. The company says the submission was based on the Phase 3 PROGRESS chronic migraine study evaluating Qulipta in adults who met the primary endpoint of statistically significant reduction
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Considerations for Rescinding Breakthrough Therapy Designation.” The guidance says that given the resource-intensive nature of the breakthrough therapy program, the agency periodically assesses whether designated products continue to meet the designation criteria. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination.” The document describes methods, facility design elements, and controls that are important in preventing drugs from being cross-contaminated with non-penicillin beta-lactam antibacterial drugs or
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations.” The document provides recommendations to sponsors planning to conduct food-effect studies for orally administered drug products. To view the notice, click here.
Drugs
FDA has published a draft guidance, Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination, describing methods, facility design elements, and controls that are important in preventing drugs from being cross-contaminated with compounds containing a beta-lactam ring. The document also provides information about the relative
Devices
FDA says Baxter Healthcare’s 4/26 recall of 268 units of its Volara system with an in-line ventilator adaptor is Class 1. An agency notice says the devices were distributed between 5/28/20 and 4/19/22. The system is intended to help people clear mucus out
Drugs
New York University bioethics professor Arthur Caplan says that among all the efforts to increase clinical trial diversity, what’s missing is a clear explanation of why it is so important. In a Stat First Opinion post, Caplan reviews some recent announcements from FDA and other stakeholders calling for greater
Drugs
FDA has published its “Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis,” a five-year plan developed to meet a requirement in the Accelerating Access to Clinical Therapies for ALS Act. The document says it will advance innovation that promotes and accelerates medical product development to treat rare
Drugs
FDA has granted Novartis accelerated approval for Tafinlar (dabrafenib) plus Mekinist (trametinib) for treating patients six years of age and older with unresectable or metastatic solid tumors with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. “The combination of dabrafenib and
Drugs
FDA has published a guidance, Assessing the Effects of Food in INDs and NDAs—Clinical Pharmacology Considerations, with recommendations for sponsors planning to conduct food-effect (FE) studies for orally administered drug products under INDs to support NDAs and supplements to those applications. The document revises and replaces part of
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Improving Communication of Important Safety Information — 21 CFR Part 200” (OMB Control Number 0910-0754). The collection supports agency regulations that outline the general provisions for “Dear Healthcare Provider” letters that manufacturers and distributors disseminate about important
Drugs
FDA has published a draft guidance, Considerations for Rescinding Breakthrough Therapy Designation, explaining how, during the evaluation of a drug development program, the agency may consider whether to rescind a breakthrough therapy designation. The document says the guidance is consistent with and supplements the information on breakthrough therapy designation included
Drugs
University of Illinois at Chicago psychiatry professor Anand Kumar says FDA should “scrutinize the accelerated [approval] program rigorously to ensure that surrogate endpoints are clinically meaningful before approving drugs under this mechanism.” Writing in an online opinion column for The Hill, Kumar traces the history of the accelerated approval program
Devices
Medtronic has recalled (Class 1) one lot of batteries for its HeartWare Ventricular Assist Device (HVAD) due to welding defects that allow separation of the two cell battery packs used to power the device. The defects may cause the battery to malfunction and no longer provide power or prevent the
FDA Policy/General
The House Appropriations Committee 6/23 voted 31 to 26 to approve an FDA spending bill for fiscal year 2023 that will boost the agency’s discretionary funding by $341 million (10%) for a total of $3.645 billion. The bill provides a “targeted increase of $64 million for the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “510(k) Third-Party Review Program” (OMB Control Number 0910-0375). The collection supports the program, such as third-party reviewer requests to participate. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Establishment Registration and Device Listing for Manufacturers and Importers of Devices — 21 CFR Part 807, Subparts A Through D” (OMB Control Number 0910-0625). The collection supports agency regulations that require medical device establishment owners and operators
Drugs
The Vermont federal court has permanently enjoined Edge Pharm, a Colchester, VT, compounding pharmacy, from distributing drugs unless they are manufactured in compliance with the Federal Food, Drug, and Cosmetic Act. A Department of Justice statement says the government alleged that the pharmacy and its owners manufactured and distributed adulterated
Devices
FDA has given 510(k) clearance and breakthrough device designation to Medtronic’s LigaPASS 2.0 ligament augmentation system. The company says it is the only FDA-cleared device indicated for ligament augmentation in spine surgery. The system “aims to compensate for muscle collapse during open posterior surgery and decrease
Drugs
FDA has approved an expanded indication for Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) to include children six weeks through 17 years of age. The vaccine is indicated for preventing invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,