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Pink Sheet provides you with keen analysis on news and regulatory trends to help you effortlessly navigate biopharma policy and inform your regulatory strategies. Gain insights that can propel your products to market success.

Download key articles from our expert journalists

Our expert journalists at Pink Sheet have selected free article packs to help you gain incisive analysis of current and future policy trends to help inform your regulatory strategies.


Article pack 1: Artificial Intelligence Regulation

Every drug sponsor wants to make the best use of Artificial Intelligence, but doing so requires understanding where health authorities are drawing the lines. That’s always something of a moving target, especially in a field as new as AI. The Pink Sheet’s globe-spanning has produced one rule of thumb, however: The closer Artificial Intelligence is to patient care, the more scrutiny it will get. Regulators seem content to allow firms to make product development decisions based on AI without significant oversight.

But if AI is used to assess a clinical trial outcome or examine manufacturing process, authorities will want to make sure that model has been thoroughly vetted – though it doesn’t necessarily need to be completely explainable.

Below is a sample of our coverage from Asia, Europe and the United States of the emerging framework for artificial intelligence regulation.

 

Article pack 2: EU’s Pharma Legislative Reform

While the outcome of the US presidential election is drawing most of ’s political attention these days, other political activity in Europe merits serious attention as well. Pharma reform legislation is moving forward in the EU that could significantly change everything from how firms manufacturer their products to how much market exclusivity they get for them. These Pink Sheet stories break down the key issues, explaining what is already basically set and what remains undecided in this major initiative.

What is Pink Sheet?

Since 1939, Citeline’s Pink Sheet has been the leader in providing business-critical insights on pharmaceutical news, and analysis of regulatory policies and trends. Our global team of over 60 journalists track product progress from submission to approval, covering all industry sectors: biosimilars, generics, OTC drugs, and more.

Hear our Pink Sheet journalists from across the globe discuss the important implications of complex biopharma regulations and identify emerging policy directions to help you navigate the every-changing regulatory standards.

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