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BioWorld - Tuesday, June 24, 2025
Home » Topics » Regulatory

Regulatory
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‘22 in review

FDA finalizes CDS guidance, but AI guidance for change control a low priority

Dec. 29, 2022
By Mark McCarty
The U.S. FDA managed to wrap up a guidance for clinical decision support (CDS) products after several years, one of several projects the agency was liable for in the area of digital health. While a much-needed draft guidance for change control for artificial intelligence algorithms made the guidance agenda for the FDA’s new fiscal year, that draft is only a B draft guidance priority, suggesting that a final guidance might not emerge until calendar year 2024, possibly later.
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FDA Approved stamp

Regulatory news, COVID data and US approvals all down in 2022

Dec. 29, 2022
By Karen Carey
U.S. FDA approvals in 2022 are down by 31.3% compared with last year and clearances for new molecular entities are at the bottom of all recent years. As of Dec. 20, the agency had approved 143 drugs and biologics in 2022, including supplemental filings, just slightly higher than the 138 approvals in 2016, but far behind the 208 approvals recorded in both 2021 and 2017.
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Japan gears up for another round of drug price revisions but stakeholders push back

Dec. 29, 2022
By Tamra Sami
Japan’s Central Social Insurance Medical Council said it would issue similar drug price revisions in 2023 as it did in 2022 for drugs listed on the National Health Insurance, confirming the move to annual price cuts on drugs.
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Lab mouse

US spending bill spares animals in preclinical drug development

Dec. 29, 2022
By Mari Serebrov
Tucked into the 4,155-page, $1.7 trillion spending bill for fiscal 2023 that U.S. President Joe Biden signed into law Dec. 23 is a small provision that may have outsized impact on future biosimilar and other drug development. Championed by lawmakers on both sides of the political spectrum, the provision modernizes the data that can be used to support drug development, including alternatives to animal studies.
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Regulatory actions for Dec. 29, 2022

Dec. 29, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB, Ardelyx, Astrazeneca, Hoth, Innocare, Kala, Minerva, Pfizer, Polarean, Transcode.
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Briumvi

TG’s anti-CD20 antibody wins FDA nod for MS

Dec. 28, 2022
By Jennifer Boggs
Despite pipeline setbacks in 2022, TG Therapeutics Inc. ended the year on a positive note, with U.S. FDA approval of its glycoengineered CD20 monoclonal antibody, ublituximab, in relapsing multiple sclerosis (MS). Branded Briumvi, the drug is set to go up against approved anti-CD20 antibodies Kesimpta (ofatumumab, Novartis AG) and Ocrevus (ocrelizumab, Roche Holding AG).
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’22 in review

MDUFA V boosts user fees, no improvement seen in FDA’s premarket review times

Dec. 28, 2022
By Mark McCarty
The fifth medical device user fee agreement (MDUFA V) included several new programs, such as a program intended to aid device makers in an efficient to-market process. However, MDUFA V also boosted device user fees for many applications by 55% but turnaround times for these applications will remain essentially flat compared to MDUFA IV.
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Ukrainian and Russian flags painted on cracked concrete

Russia imposing its regulatory framework on Ukrainian territories

Dec. 28, 2022
By Mari Serebrov
Although the war is still raging in Ukraine, Russia is marching forward with asserting its regulatory framework on health care in the parts of Ukraine it’s claiming as the spoils of the war it started 11 months ago.
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ABPI looks to new settlement to tame UK drug rebates

Dec. 28, 2022
By Mari Serebrov
Facing a 26.5% rebate on 2023 sales of branded prescription drugs in the U.K., the Association of the British Pharmaceutical Industry (ABPI) is seeking talks with the government early in the new year to develop a new biopharma settlement for the future that will reflect the potential of the life sciences sector to drive improvements in the health and economy of the U.K.
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Map of Australia with pills, vials and syringe

Australia delivers new National Medicines Policy aiming to deliver greater access to medicines

Dec. 28, 2022
By Tamra Sami
The Australian government delivered an early Christmas present to the biopharma industry in the form of a new National Medicines Policy giving voice to major industry goals – among them a clear vision to “achieve the world’s best health, social and economic outcomes for all Australians through a highly supportive medicines policy environment.”
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