Drug Discovery World

JULY 25, 2023

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects. The section on ethics covers two examples of paediatric ethical factors 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