category legal-regulatory 
Pharmaceutical Technology
DECEMBER 5, 2022
Cannabinoid receptors fall into two categories: CB1 and CB2 receptors. Despite the current popularity of cannabinoid receptors, the regulatory landscape is challenging and complex. In the US, the world’s largest pharmaceutical market, most states have legalized cannabinoids for medical use.
Nixon Gwilt Law
SEPTEMBER 7, 2023
However, as with any emerging area of healthcare innovation, new legal and regulatory considerations arise that must be thoughtfully addressed. Here are the critical legal issues pediatric digital health companies need to be thinking about today. Want to tackle these legal hurdles with confidence? Additionally, the U.S.
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Nixon Gwilt Law
NOVEMBER 16, 2023
But what exactly is AI, how is it impacting the healthcare industry, and what are the legal and regulatory concerns you need to understand if you are building a healthcare AI solution? In this post, we’ll first define “generative AI” and where it fits within the broad category of machine learning. Now let’s get to it.
Clarivate
JUNE 21, 2023
It also added to the daunting regulatory complexity the industry faces, coming on top of the new Medical Device Regulation (MDR) efforts and investment, which went into force in May 2021. Under the existing MDR framework, medical devices fall into different risk categories (i.e., There’s concern as well about other E.U.
PM360
OCTOBER 28, 2022
billion dollars to bring a new drug from discovery to regulatory approval and market launch. Regulatory agencies have started formulating high-level guidelines to address these challenges. Last year, the International Coalition of Medicines Regulatory Authorities (“ICMRA”), which includes the U.S.
European Pharmaceutical Review
FEBRUARY 21, 2023
The UK medicinal cannabis sector has witnessed important regulatory advances in recent years. After the substance became legal in the UK in 2018, pharmaceutical companies have faced numerous obstacles to attain a fairer position in the industry. What limitations in the regulatory framework did Celadon need to navigate?
pharmaphorum
SEPTEMBER 29, 2022
If so, developers must develop and execute on a regulatory strategy. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. Food and Drug Administration (FDA) regulation as a medical device. General Wellness Products.
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