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Regulatory actions for Sept. 29, 2022

Sep. 29, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambulero, Azura, Biosyngen, Celltrion, Maruishi.
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Telehealth illustration

GAO cites privacy, program integrity concerns in connection with Medicare telehealth

Sep. 28, 2022
By Mark McCarty
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.
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EBG’s Thompson rips FDA guidance for CDS software as counter to intent of Cures Act

Sep. 28, 2022
By Mark McCarty
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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Antibiotics development incentive scheme makes economic sense, EFPIA says

Sep. 28, 2022
By Mari Serebrov
To jumpstart the development of much-needed antibiotics, the European Federation of Pharmaceutical Industries and Associations (EFPIA) released a new report Sept. 28 demonstrating the economic benefit of granting additional exclusivity for another drug as a way of incentivizing antibiotic R&D.
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US Medicare beneficiaries to get small relief in Part B premiums

Sep. 28, 2022
By Mari Serebrov
The U.S. Centers for Medicare & Medicaid Services is finally making a long-expected, and requested, adjustment to Medicare Part B premiums, which were raised nearly 15% for 2022 in the wake of Biogen Inc.’s initial $56,000 annual price tag for its Alzheimer’s drug, Aduhelm (aducanumab).
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Regulatory actions for Sept. 28, 2022

Sep. 28, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mesh Suture.
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Regulatory actions for Sept. 28, 2022

Sep. 28, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Angel, Astrazeneca, Atai, Avidity, Ayala, Bellerophon, Corvus, Crispr, Legend, Merck & Co., Moonlake, NMD, Vertex.
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FDA tightens eligibility for COVID-19 emergency use authorization program

Sep. 27, 2022
By Mark McCarty
The COVID-19 pandemic may or may not be over, depending on which member of the U.S. government’s executive branch one asks, but the FDA’s device center has drawn much tighter lines around its emergency use authorization (EUA) program for COVID-19 tests.
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FDA’s pre-cert pilot for SaMD falters over lack of statutory authority

Sep. 27, 2022
By Mark McCarty
The U.S. FDA’s final report for the software pre-certification (pre-cert) pilot program for software as a medical device (SaMD) highlighted a number of both positive and negative developments, but the agency reiterated its call for new statutory authorities for review of SaMD. However, the agency also acknowledged that the pilot was itself compromised by the absence of that statutory authority because the absence of such authority means that the results of these mock product reviews cannot be legally walled off from non-pilot applications.
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Handshake with DNA, molecules

Scribe, Vertex add to gene therapy's advance with $1B+ deal, near-term BLA

Sep. 27, 2022
By Michael Fitzhugh
CRISPR-based cell therapies continued to gain steam Sept. 27 with the announcements of a potentially valuable big pharma collaboration and an ambitious global regulatory push.
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