Conversations in Drug Development Trends

OCTOBER 26, 2022

Having worked in psychedelic research since the advent of industry-sponsored trials, Worldwide Clinical Trials has amassed the expertise needed to execute these studies successfully, recently sharing insights in a webinar titled “ Demystifying Complex Operations in Psychedelic Research ,” available on-demand now. Check out the full webinar !

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Drug Discovery World

MARCH 29, 2023

According to the Wellcome Trust 5 , it can take between 10 and 15 years and over $1billion to develop a new antibiotic, so systems such as this aim to provide incentive to drug developers. In the same webinar, Emer Cooke, EMA Executive Director, countered, in relation to regional drug approvals, “Faster isn’t necessarily better.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

MARCH 1, 2024

FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program.

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Agency IQ

AUGUST 2, 2024

September 30, 2024 PDUFA Novel Approaches to Development of Cell and Gene Therapy Convene a public meeting to solicit input on methods and approaches (e.g., use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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Agency IQ

JUNE 2, 2023

BY ALEXANDER GAFFNEY, MS, RAC AUG 31, 2022 6:50 PM CDTUPDATED MAY 25, 2023 6:12 PM CDT What we expect to be talking about in June: Supply chain information: Under the FDORA legislation, holders of Biologics License Applications are required to submit a one-time report to the FDA on June 25, 2023 regarding which of their biologic products are available (..)

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Agency IQ

FEBRUARY 2, 2024

Title Type Comments Close Digital Health Technologies for Detecting Prediabetes and Undiagnosed Type 2 Diabetes January 31 Advancing the Development of Therapeutics Through Rare Disease Patient Community Engagement Meeting February 12 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Establishment Notice February 12 Advanced Manufacturing (..)

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