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 U.S. Court of Appeals for the Seventh Circuit has affirmed an injunction obtained by Life Spine Inc. against L&K Biomed for the latter’s alleged appropriation of trade secrets obtained by an L&K subsidiary. The outcome affirms that injunctive relief is available to plaintiffs when irreparable harm is plausibly alleged, but also highlights the need for internal controls to avoid accidental use of trade secrets during product development programs.
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.
Rick Bright, who filed a whistleblower complaint last year against the U.S. Department of Health and Human Services (HHS) after he was removed from his position as director of the Biomedical Advanced Research and Development Authority (BARDA), reached an undisclosed settlement with HHS, the U.S. Office of Special Counsel reported Aug. 9.
A three-month delay proved to be of no concern for Nexviazyme (avalglucosidase alfa-ngpt, neoGAA), Sanofi SA’s long-term enzyme replacement therapy (ERT), which gained FDA approval for intravenous infusion to treat patients 1 and older with late-onset Pompe disease.
Novavax Inc. now says it plans to submit an emergency use authorization (EUA) to the FDA for its highly efficacious COVID-19 vaccine, NVX-CoV2373, sometime in the fourth quarter, backing off previous plans of a second-quarter and then a third-quarter filing.
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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