Agency IQ

AUGUST 16, 2024

FDA released a draft guidance in June 2023 attempting to address many of these unique aspects of clinical research on psychedelic substances. Many commenters took issue with the guidance’s statement that, “The contribution of the psychotherapy component to any efficacy observed with psychedelic treatment has not been characterized.

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Drug Discovery World

SEPTEMBER 28, 2022

With the advent of natural language processing, algorithms can now also contextualise these data and, combined with trend analysis, can guide researchers towards areas more likely to show promising treatments. . Which areas of drug discovery research stand to benefit most? . billion in 2021, an increase of 79% from 2020.

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The Premier Consulting Blog

NOVEMBER 20, 2023

Clinical development experts would need to navigate the potential complexities arising from this regulatory shift, particularly in terms of trial design and evidence generation. Our team is helping clients navigate the changing regulations and clinical research.

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Laboratories FDA Clinical Development Regulations 52

Drug Discovery World

AUGUST 10, 2022

Until about 25 years ago, the best treatment option for someone with blood cancer was either toxic radiation and chemotherapy or a bone marrow transplant that posed additional life-threatening risks to the patient 1. Next, the advent of antibody treatments in 1997 created the first targeted cancer therapy 2.

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