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BioWorld - Saturday, March 7, 2026
Home » Topics » Regulatory

Regulatory
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Australian flag on laptop screen with health professional

Australia begins first independent review of its health technology assessment process

Jan. 27, 2023
By Tamra Sami
The Australian government has begun its closely watched independent review of the health technology assessment (HTA) process in the country, and it delivered a first peek at what it will consider. This independent review of the HTA system is the first of its kind in nearly 30 years.
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Regulatory actions for Jan. 27, 2023

Jan. 27, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Infinity Neuro.
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Regulatory actions for Jan. 27, 2023

Jan. 27, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Centessa, Daewoong, Daiichi, Discgenics, Lapix, Syros, Valeo.
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Judge's gavel with US flag

US GAO report highlights growing use of third-party funding in product liability litigation

Jan. 26, 2023
By Mark McCarty
Makers of medical devices and pharmaceuticals face a significant risk of product liability litigation, but the use of third-party funding of such lawsuits is a novelty in the U.S. relative to some other Western nations. Nonetheless, a new report by the U.S. Government Accountability Office (GAO) makes clear that third-party litigation funding (TPLF) is an increasing common practice that seeks to include uninjured parties in mass tort litigation, thus endangering the fortunes of those who invest in life science companies.
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China grapples with regulating online drug sales

Jan. 26, 2023
By Tamra Sami
China’s National Medical Products Administration is grappling with how to regulate drugs that are sold online as it issued new provisions under the country’s Drug Administration Law that allows prescription drugs to be sold online for the first time.
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FDA vaccine illustration

VRBPAC backs simplification of COVID-19 vaccines

Jan. 26, 2023
By Mari Serebrov
Harmonization and simplification won the day as the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) looked toward the future of COVID-19 vaccines in the U.S. Jan. 26. The committee voted unanimously, 21-0, to recommend using the same strain composition for all COVID-19 vaccines available in the U.S., whether they’re used for primary doses or boosters. Such standardization also would align the composition of Novavax Inc.’s protein-based vaccine with that of the mRNA vaccines produced by Moderna Inc. and Pfizer Inc.-Biontech SE.
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Chinese flag, pills

China adds 111 new drugs to NRDL, focus on innovation

Jan. 26, 2023
By Zhang Mengying
Citing efforts to “encourage innovation,” China’s National Healthcare Security Administration included 111 new drugs in its National Reimbursement Drug List (NRDL). The adjustment, shared Jan. 18, 2023, also removed three drugs, leaving the latest NRDL with a total of 2,967 drugs. Most of the newly added drugs are recently approved drugs, with many making it to the market in the last five years. Twenty-three were approved in 2022.
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Regulatory actions for Jan. 26, 2023

Jan. 26, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alk-Abello, Cidara, Fabre-Kramer, Immuron, Inhibikase, Oncotelic, Poxel, Tango.
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DME, phlebotomy services at center of health care fraud allegations

Jan. 25, 2023
By Mark McCarty
Fraud perpetrated on U.S. federal health care programs is the stuff of nightmares among U.S. enforcement agencies, and yet another pair of fraudsters have been rounded up by the Department of Justice (DOJ).
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Brazilian flag

Brazil’s new medical device rules starting in March promise to simplify process

Jan. 25, 2023
By Sergio Held
Brazilian health care regulator Anvisa unveiled new medical device rules that promise to simplify over two decades of accumulated directives, putting into force changes announced by the health care surveillance agency in 2022.
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