The FDA’s device center has generated a raft of warning letters for products related to the COVID-19 pandemic, and released another six such letters for the week of Aug. 9. However, the ostensible justification for those warnings varies considerably, as does the elapsed time between the date of the warning letter and its issuance on the FDA’s warning letter webpage.
The FDA’s latest version of the intended use rule is a complex, 61-page document that cleaned up a few things from the previous version and added a phrase or two to the regulatory lexicon. Randy Prebula, a partner in the D.C. office of Hogan Lovells U.S. LLP, told BioWorld that while the FDA left itself some wiggle room by avoiding a prescriptive use of language in the rule, the final rule is unlikely to be the final word on the intended use question.
The digital therapeutics market has seen an explosion of innovative products and interested investors. Regulators, too, have acknowledged their potential to improve outcomes in patients with chronic or debilitating conditions – often at lower cost and with less side effects than traditional drug therapies. To that end, the FDA has granted breakthrough device designation to Swing Therapeutics Inc. for its prescription digital therapeutic for the management of fibromyalgia.
Fibrogen Inc. was braced for receiving a complete response letter (CRL) and it got one. The FDA suggested it would not approve roxadustat’s NDA for treating anemia of chronic kidney disease until more clinical work is conducted. In July, the FDA’s Cardiovascular and Renal Drugs Advisory Committee said basically the same thing as it voted 13-1 against approval for the nondialysis population and 12-2 against approval for patients on dialysis unless more trial data are submitted.
The FDA reported that Boston Scientific Corp. has recalled several models from the Ingenio line of cardiac electrophysiology devices in a class I action that affects 48,000 devices. The recall was triggered by the risk that these devices will inappropriately shift into safety mode and thus be unable to provide pacing, as demonstrated by 65 such incidents and three instances in which patients needed external pacing in response to the problem.
The FDA has given the green light to Spintech Inc. for its STAGE (strategically acquired gradient echo) magnetic resonance imaging device. The post-processing software platform allows MRI technicians to capture higher-quality brain images in significantly less time than standard approaches.
Rather than appeal an April decision by the U.S. Court of Appeals for the District of Columbia Circuit, the FDA is changing how it regulates imaging agents. That means the agency will transition at least some approved imaging agents from drug status to device status and, going forward, it will regulate products that meet both the device and drug definition as devices – unless Congress specifies otherwise.
Shares of Axsome Therapeutics Inc. (NASDAQ:AXSM) hit a 52-week low on Aug. 9, falling 46.5% to close at $24.37, after the FDA said deficiencies in an NDA in major depressive disorder for its drug, AXS-05 (dextromethorphan + bupropion), would "preclude labeling discussions" for now.
Zoll Medical Corp. has released its Remedē EL-X system for the treatment of central sleep apnea in adults, following the receipt of FDA approval. The next-generation implantable neurostimulation device will be rolled out in a phased launch in implanting centers in the U.S.
The FDA’s quarterly report on device user fee performance goals encodes a number of metrics, such as the rate at which PMA originals are cited for a major deficiency on the first review cycle. For premarket approval applications (PMAs) filed in fiscal year 2021 to date, the major deficiency rate on the first cycle is 86%, which would be tied for the fifth highest rate in two decades if that rate holds throughout the balance of the fiscal year.
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