Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding.

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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. This study is planned to start in late 2024 and conclude in late 2025.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Image Thumbnail_diversity in clinical trials_VAbutton.jpg Synopsis Representation and inclusion of various minority groups is crucial for medical research.

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FDA Law Blog: Drug Discovery

JULY 9, 2024

Another question is the impact on rare disease drug development, where broader populations are small and there may be limited knowledge about differential impacts of disease. This means, under Congress’s direction in FDORA, the FDA should be trying to finalize the Draft Guidance around June 2025.

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Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. has published psychedelic-specific guidance and has several ongoing psychedelic clinical trials.

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Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

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Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.]

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PPD

JANUARY 21, 2025

As 2025 kicks off, the biopharma and biotech industries find themselves at a pivotal juncture, navigating an era of rapid transformation marked by new technological advancements, evolving regulations and shifting industry priorities. However, amid this progress, the complexities of drug development have never been more apparent.

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FDA Law Blog: Drug Discovery

FEBRUARY 27, 2025

Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025. While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3).

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PPD

MARCH 19, 2025

The drug development landscape continues to grow in complexity and cost. Drug developers should consider several approaches when implementing an FSP partnership that is fit-for-purpose and positioned for optimal performance.

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Clinical Development Drug Development Clinical Research Drugs 52

Perficient: Drug Development

JANUARY 24, 2025

Knowledge Management & Clinical Research The exponential growth of medical knowledge presents both challenges and opportunities for acute care providers. GenAI can serve as a powerful tool for knowledge management and clinical research, enabling healthcare organizations to stay at the forefront of evidence-based practices.

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