Drug Discovery World

JULY 20, 2023

Diana Spencer summarises the key messages from the ‘Drug Repurposing: Challenges and Opportunities’ Symposium held at the 19th World Congress of Basic & Clinical Pharmacology (WCP) 2023. Pitceathly argued that interdisciplinary collaboration and good preclinical data is key to successful clinical trials.

Clinical Pharmacology 100

Clinical Pharmacology Clinical Trials Drugs Trials 100

New Drug Approvals

DECEMBER 24, 2023

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 7 March 2023. Archived from the original on 26 September 2023. Retrieved 21 December 2023 – via PR Newswire. February 2023). October 2023). 1] It is a transthyretin-directed antisense oligonucleotide. [1] PMC 9837340.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

Agency IQ

FEBRUARY 12, 2024

In total, since August 2023, there have been 34 new guidances added to the agenda, 58 that have been carried over to the new calendar year, and 28 which were removed (most—but not all—of which were published since the last guidance agenda update). This week, CDER published its guidance agenda for 2024.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Select Updates for the 506J Guidance: Voluntary Notifications of Discontinuance or Interruption of Device Manufacture CDRH Draft 12/29/2023; overdue FDA must issue final guidance within one year after the close of comments for the draft guidance. New on CDRH’s guidance agenda. Priority A List.

FDA 40

FDA Science Biosimilars Production 40