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BioWorld - Wednesday, July 6, 2022
Home » Topics » Regulatory

Regulatory
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Adcom spurns Acadia’s Nuplazid in ADP; ‘simple and unfortunate story’

June 17, 2022
By Randy Osborne
No Comments
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).
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Regulatory actions for June 17, 2022

June 17, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Nonagen Bioscience.
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China to ramp up volume-based procurement policies for drugs and devices to control prices

June 17, 2022
By Tamra Sami
No Comments
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.
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Regulatory actions for June 17, 2022

June 17, 2022
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Hansa, Savara.
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U.K. flag on stethoscope

MHRA goes big with harmonization with IMDRF, ICH

June 16, 2022
By Mark McCarty
No Comments
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.
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US health agencies told go back to their offices

June 16, 2022
By Mari Serebrov
No Comments
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.
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Standards program aimed at streamlining US regenerative medicine efforts

June 16, 2022
By Mari Serebrov
No Comments
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.
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Regulatory actions for June 16, 2022

June 16, 2022
No Comments
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.
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Regulatory actions for June 16, 2022

June 16, 2022
No Comments
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.
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FDA finalizes quantitative imaging guidance

June 15, 2022
By Mark McCarty
No Comments
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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