After winning the backing of European regulators, Biomarin Pharmaceutical Inc. is returning to the U.S. FDA with its hemophilia A gene therapy, valoctocogene roxaparvovec, following a rejection in August 2020. It's armed with data it hopes will assuage concerns about long-term safety and benefits.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: GE Healthcare, Intuitive Surgical.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Biogen, Biomarin, Catalyst, Evgen.
The notion that advances in artificial intelligence (AI) are a question of national economic competitiveness has been gaining currency of late, and a hearing in the U.S. House of Representatives lent more credence to the idea. Jordan Crenshaw of the U.S. Chamber of Commerce referred to the hazard of allowing dictatorships to set the standard for the use of AI as well as the ever-increasing global economic impact of these algorithms, adding that when it comes to AI, the U.S. is “in a race we must win” for both ethical and economic reasons.
U.S. lawmakers concerned about unconfirmed clinical benefit of drugs with accelerated approval got more fodder for their arguments in a new report from the Department of Health and Human Services Office of Inspector General (OIG). According to that report, which was released Sept. 29, Medicare and Medicaid have spent more than $18 billion over the past few years covering 18 drugs granted accelerated approval that haven’t completed their confirmatory trials even though the trial completion dates have passed.
Recognizing that academic sponsors and nonprofits are major contributors to the development of advanced therapy medical products (ATMPs) and diagnostic and delivery devices, the EMA is launching a pilot program to help them navigate the challenging regulatory requirements in the space.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beyeonics Vision, Neosoma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambulero, Azura, Biosyngen, Celltrion, Maruishi.
The U.S. Government Accountability Office (GAO) recently published a report on the pandemic-driven expansion of telehealth for Medicare beneficiaries, and pointed to some privacy and security risks of which patients may be unaware. However, GAO also noted that the CMS does not yet have a good handle on the rate of telehealth fraud and has not yet collected reliable data on telehealth outcomes, two gaps that will have to be filled if Congress is to comfortably vote to make permanent some of these pandemic-driven telehealth policies.
The saga of U.S. FDA regulation of clinical decision support (CDS) software has spanned six years since the passage of the 21st Century Cures Act, yielding two FDA draft guidances and a final guidance that emerged only Sept. 27, 2022. Regulatory attorney Brad Thompson blasted the final guidance for its addition of “time-critical decision making” to the definition of a regulated medical device, one of several features he argued are extra-statutory and which effectively handcuff both developers of CDS and the physicians who use their products to aid in selecting drug and device treatments.
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