The Premier Consulting Blog

NOVEMBER 20, 2023

Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. This change is driven by the intent to consistently regulate all producers of such devices. Expanded Definition: FDA aims to reshape the boundaries of IVDs within 21 CFR Part 809.3.

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Laboratories FDA Clinical Development Regulations 52

Drug Discovery World

SEPTEMBER 28, 2022

In fact, the market research firm, Bekryl, predicts that AI has the potential to offer over $70 billion in savings for the drug discovery process by 2028. . For the wider industry, what we are likely to see as a result is that smaller biotechnology companies are pushed to focus on more niche research. .

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Pharma Companies Hospitals Clinical Trials Drugs 130

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. The study is planned to begin in 2026 and conclude in 2028.

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FDA Trials Regulations Therapies 40

Drug Discovery World

AUGUST 10, 2022

For example, it is challenging to regulate transgene copy numbers in each T cell, posing safety risks. Although transgenes show a preference for certain sites, the CAR transgene could integrate into the T cell genome at any location, including within a sequence that regulates oncogene expression, thereby increasing cancer risk.

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