The U.S. Department of Health and Human Services is proposing to withdraw or repeal a Trump-era rule imposing expiration dates on most of the rules implemented by the department and its agencies, including the FDA.
The FDA has struggled to revise a guidance related to cybersecurity in medical devices, but developers now have more than just lagging FDA guidances to worry about where cybersecurity is concerned. The U.S. Department of Justice (DoJ) has unveiled a program designed to leverage the False Claims Act to pursue entities that come up short of regulatory expectations for cybersecurity, constituting a new vector for liability for makers of devices and medical software.
Negotiations between the FDA’s device center and the med-tech industry over the next device user fee schedule are dragging on, but the gap between the two sides may have narrowed. The FDA had previously proposed a package that ran more than double the current total user fee volume, and industry has responded with a proposal that would provide the agency with $1.65 billion in user fees over five years, leaving the two sides with a gap of more than $800 million to bridge.
Targeting the thousands of rare inherited diseases that have no treatments in the U.S., a newly launched public-private group plans to pursue efforts to optimize and streamline the gene therapy development process.
As part of its ongoing research into drug advertising, the FDA’s Office of Prescription Drug Promotion (OPDP) is proposing a study to understand how “targeted mechanism of action” (MoA) claims influence patients and health care providers when they’re used in drug ads and other promotional materials.
The U.S. Federal Trade Commission (FTC) has restored a rule that requires prior authorization for any mergers that affect a market that was the subject of previous allegations of attempted anticompetitive behavior. The agency’s press release on the change seems to respond to the decision by Illumina Inc. to complete its acquisition of Grail Inc. and its multicancer screening test, as indicated by the statement that the policy would address the behavior of companies that see little risk to their long-term market strategies despite FTC opposition to an acquisition.
The FDA’s device center has posted its annual fiscal year guidance agenda, and there are several carry-over items from fiscal 2021. The most conspicuous element of the FY 2022 agenda may be that a draft guidance for change control for artificial intelligence (AI) algorithms rates an entry on the B list rather than the A list, suggesting that the draft is not likely to emerge any time in the next 12 months.
The U.S. Federal Trade Commission (FTC) has restored a rule that requires prior authorization for any mergers that affect a market that was the subject of previous allegations of attempted anticompetitive behavior. The agency’s press release on the change seems to respond to the decision by Illumina Inc. to complete its acquisition of Grail Inc. and its multicancer screening test, as indicated by the statement that the policy would address the behavior of companies that see little risk to their long-term market strategies despite FTC opposition to an acquisition.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 17-0, with one abstention, that the benefits of Pfizer Inc.-Biontech SE pediatric formulation of its two-dose COVID-19 vaccine outweigh its risks for children ages 5 through 11. Many of those votes came with caveats, as the VRBPAC members struggled with the unknowns of the vaccine and the fear that schools would mandate its use, even though it would still be considered experimental if the FDA grants it an emergency use authorization.
The brain-computer interface (BCI) is the subject of keen medical interest for those dealing with neurological damage, but military applications are also a point of interest among a number of national governments. With all this in mind, an agency at the Department of Commerce has posted a request for comments regarding a possible imposition of export controls on BCI devices due to national security concerns, a proposal that could complicate exports of such devices for medical use.
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