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The U.S. FDA’s Psychopharmacologic Drugs Advisory Committee took up the complicated matter of Acadia Pharmaceuticals Inc.’s sNDA for Nuplazid (pimavanserin) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP).
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nonagen Bioscience.
China will continue to ramp up volume-based procurement (VBP) policies that bring down drug and device prices for public hospitals with volume. Governmental agencies at the local and national levels coordinate drug prices via government-organized procurement programs that include VBP and pricing negotiations for inclusion on the National Reimbursable Drug List.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Hansa, Savara.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) is still considering a drastic overhaul of the 2002 medical device regulatory framework, but may have sent a signal that its new framework won’t deviate too far from established regulatory approaches. The agency reported June 16 that it has signed on with both the International Council for Harmonization (ICH) for drugs and the International Medical Device Regulators Forum (IMDRF) for devices, providing members of both industries with at least some modest confidence that access to the 67 million strong U.K. market won’t suffer from a new set of unique regulatory hurdles.
What was billed as a U.S. Senate Health, Education, Labor and Pensions Committee hearing June 16 to get an update from top government health officials on the nation’s response to COVID-19 was, in reality, a concerted effort to get Republicans in the U.S. Senate to open the checkbook so the Biden administration could fill in the amount for more COVID-19 spending, Ranking Member Richard Burr (R-N.C.) charged as he concluded the hearing.
In keeping with the 21st Century Cures Act, the U.S. FDA issued a draft guidance describing a standards recognition program for regenerative medicine therapies at the Center for Biologics Evaluation and Research that’s intended to facilitate the development of the therapies and reduce the regulatory burden.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascensia Diabetes Care, Imagia Canexia Health, Novarad, Senseonics, Sysmex America.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 180, Biontech, Covis, Horizon, Jazz, Kintara, Moderna, Omega, Pfizer, Phanes, Redx.
Quantitative imaging (QI) is making an increasingly larger footprint in clinical practice, and the U.S. FDA has rounded out a 2019 draft guidance spelling out the agency’s expectations regarding technical performance assessment of this class of products. Developers of software that provide quantitative data from imaging studies should expect to conduct studies that ensure the software controls for a wide range of sources of error, suggesting that studies of these algorithms could prove expensive.
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