Drug Discovery World

NOVEMBER 29, 2022

After just one cohort of students, the Clinical Pharmacology degree at St George’s University has been named the UK’s best pharmacology course. Due to this approach, the Clinical Pharmacology degree has various features that make it different to other courses that are currently available. Providing a broad view.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

New Drug Approvals

DECEMBER 24, 2023

December 2022). “Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. Viney, Nicholas J.; Schneider, Eugene; Guo, Shuling; Henry, Scott; et al. 88 (12): 5389–5398. doi : 10.1111/bcp.15468.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. The goal: To allow regulatory professionals to better anticipate and prepare for upcoming events and catalysts. The Agenda is typically updated twice per year, and it was last released in early January 2023.

FDA 40

FDA Science Regulations Compliance 40

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. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Amanda Conti, AgencyIQ Notably, the increase from FY 2022 was largely driven by biologic products. As a reminder, the U.S. See AgencyIQ’s analysis of these changes here.

FDA 52

FDA Biosimilars Science Production 52