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.
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.
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).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Mesh Suture.
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.
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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