The FDA has undertaken several new actions in connection with breast implants, including a new restriction on distribution to implant centers that review a pre-implant checklist with patients receiving implants. However, the agency has also mandated that manufacturers add a black-box warning of potential adverse events, such as the risk of developing anaplastic large cell lymphoma (ALCL).
In an effort to advance a fiscal 2022 spending package through a divided Congress, U.S. President Joe Biden released the framework for his Build Back Better agenda Oct. 28 – minus provisions that would allow Medicare to directly negotiate at least some prescription drug prices.
The EMA and the EU Heads of Medicines Agencies are launching a pilot project to support not-for-profit organizations and academia in the repurposing of an authorized drug for a new indication in an area of public health interest.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Axial, Bharat, Biontech, Bio-Path, Eli Lilly, Medicenna, Novartis, Novavax, Ocugen, Pfizer, Quell, Vitti.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Sibel Health.
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.
To help better utilize real-world data in drug development, the EMA published its final guideline Oct. 26 on the use of registry-based studies to support regulatory decision-making.
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