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Islet transplantation for type 1 diabetes: Do regulators have it right?

Pharmaceutical Technology

Diabetes researchers oppose the regulation of islet transplantation as a biologic, following the approval of CellTrans’ Lantidra.

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2022 in review: Regulation starts to catch up with AI in pharma

Pharmaceutical Technology

But as the field grows in leaps and bounds, many authorities have prioritised the release of new guidelines, frameworks, and regulations to keep pace with these advances. This could spell high-stake consequences for consumers whose privacy and safety could be at risk if AI models are not regulated. Major AI deals in 2022.

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What does Biden’s executive order mean for worldwide AI regulation?

Pharmaceutical Technology

The executive order highlights the US sentiment towards AI regulation, but presents a fragmented approach with possibility of discord.

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FDA Pharmacovigilance Regulations Update

ProRelix Research

The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as […] The post FDA Pharmacovigilance Regulations Update appeared first on ProRelix Research.

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National Commission for Homoeopathy notifies BHMS regulations

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Commission for Homoeopathy has prepared a regulation defining a structure to the Bachelor of Homoeopathic Medicine and Surgery (BHMS) course with changes including incorporation of a methodology to supplement modern advancement, research and technology in Homoeopathy (SMART-Homoeopathy).

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Amylyx's ALS drug Albrioza rebuffed by EU regulator—again

Fierce Pharma

Europe's drug regulator wasn't swayed by Amylyx's phase 2 data. Even as Amylyx’s ALS drug gains steam in the U.S. after a long-awaited FDA approval, the company is struggling with regulatory hurdles overseas. The European Commission will make the final call on the drug's approval in the bloc by the end of the year.

Drugs 126
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How Will AI in Hiring Be Regulated?

BioSpace

With 88% of life sciences organizations using or planning to use AI in recruitment and/or hiring, AI regulation is a priority for the industry.