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Policy & Regulation

Regulatory developments from the EU and the US are having widely felt effects on companies operating globally in both medtech and biopharma. The patents and pricing battle has engulfed the FDA and USPTO, while the impact of MDR and IVD regulation changes can be felt keenly for those in working in Europe.

2023: Will The Road Ahead Be Any Smoother For The EU’s Medtech Regulations?

Originally intended to increase medical device safety, the implementation of the EU’s medtech regulation was so hampered in 2022 that it had started to look as if the new regulations were a bigger potential threat to patients than any of the scandals leading to its more stringent requirements. With the European Commission’s latest plans to ease challenges around implementation, will 2023 be a more positive year for the EU medtech sector?

Battle Over Patents And Drug Pricing Engulfs FDA And USPTO

President Biden and Congress are pressuring the agencies to change patent policies so brand manufacturers cannot delay generic and biosimilar competition to keep monopoly prices. Timeline shows how they have responded to these demands.

N Of 2: Reflections On The Makena, Avastin Accelerated Approval Withdrawal Hearings

Despite major differences in the sponsors, drugs and circumstances, the outcomes from the hearings on Makena’s continued availability and Avastin’s breast cancer indication were strikingly similar, with overwhelming votes in favor of withdrawal. In the process, however, both sponsors gained extra commercial time for their products.

As US House Changes Hands, CMS May Face More Oversight Than FDA

Key Republican committee chairs on health issues are familiar faces, largely supportive of the US FDA’s approach to drug regulation. Implementation of the new pricing law, however, will get a lot more scrutiny.

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Evolving Technology:
Regulatory Outsourcing In A Collaborative World

Michelle Gyzen, Senior Director of Strategic Regulatory Solutions at IQVIA

Going back 20 years, regulatory activity was always stringently retained in-house by organizations. For many, it was viewed as part of a core competency for organizations, and some elements of regulatory still are today.

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Outlook 2023 e-Book

Outlook 2023 cover

Download a PDF copy of the Outlook 2023 collection, including Scrip 100 league tables.