Fierce BioTech

DECEMBER 23, 2024

First-in-Human, Drug-Drug Interaction, Food Effect, Bioequivalence, etc.), and often require consistent batches of drug product be administered to groups of research participants within a short timeframe, early phase studies present unique challenges for drug developers not typically experienced in later stages of development.

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Pharmacy Trials Clinical Trials Clinical Development 52

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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FDA Trials Therapies Regulations 40

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. What ever happened to that thing?

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FDA Science Regulations Production 40

Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

FDA 40

FDA Science Biosimilars Clinical Trials 40

Drug Target Review

MARCH 13, 2025

Planning the journey from data to deliverables The future of AI-enabled drug development benefits from the continued advancement of multimodality and clinical genomics, with a focus on integration, efficiency and personalisation to transform both care and R&D.

Drug Development 59

Drug Development Clinical Trials Science FDA 59

Drug Channels

FEBRUARY 3, 2025

Informa Connect's Access USA March 18-20, 2025, Pre-Event Workshops on March 17 Drug Channels readers save 10%* on their registration with code 25AUSA10 Three events. Rare Disease Summit Download Agenda While the industry has seen heightened focus surrounding rare drug development, weve only scratched the surface.

Specialty Pharmacies 52

Specialty Pharmacies Pharmacy Government Disease 52