Drug Discovery World

JULY 25, 2023

General clinical pharmacology This FDA draft guidance was previously issued in 2014 but was re-issued for comments again in 2022. The guidance covers three main areas: clinical pharmacology considerations, ethical considerations, and the paediatric study plan design including points to consider.

Drug Development 130

Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

Agency IQ

SEPTEMBER 29, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

As part of the classification process, we are required to discuss the potential classification before an advisory committee and seek the committee’s recommendation on classification, which took place in October 2014.

FDA 40

FDA Science Regulations Production 40