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Policy & Regulation

Big-picture policy developments – Brexit in Europe and the elections in the US – will have significant impact on biopharma in 2021. India is at the forefront of the telemedicine trend that has been evolving over many years.

Time For Independent US FDA? COVID Political Pressure Reignites Debate

The political spotlight on the FDA during the coronavirus pandemic has renewed long-standing debate as to whether it should be made an independent, Cabinet-level federal agency and freed from direct HHS oversight.

Brexit: The View For Pharma In 2021 And Beyond

With the end of the Brexit transition period fast approaching, life sciences companies need to be ready for some major changes to drug regulations as well as the impact of new border and customs controls on the flow of medicines between Great Britain, Northern Ireland and the EU. In Vivo looks at what is at stake, and what still needs to be done, as the UK prepares to leave the EU single market and customs union at the beginning of 2021.

Indian Telemedicine Prospects Boosted By Long-Awaited Guidelines

Guidelines outline permitted practices and patient safeguards for both physicians and technology platforms.

Winners And Losers: A Deep-Dive Into The EMA’s PRIME Scheme

Nine of the 70 medicines for unmet medical needs that have to date won a place on the European Medicines Agency’s PRIME scheme are now approved for sale in the EU, and two more approvals are expected soon. Meanwhile, most applications for a "priority medicine" designation are still missing the mark.

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Pharmacovigilance (PV) and Regulatory leaders may have different goals, but they face many common obstacles.

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