Evidence at time of regulatory approval and cost of new antibiotics in 2016-19: cohort study of FDA approved drugs

  15 December 2022

Antibiotics approved by the FDA from October 2016 to December 2019 were identified, and key features of their clinical development were extracted from publicly available FDA databases, ClinicalTrials.gov, and drug labelling. 

New antibiotics have been approved by the FDA in recent years mostly based on fewer, smaller, and non-inferiority pivotal trials that often used surrogate outcome measures but were commonly more costly. Efforts to incentivise the development of antibiotics should balance growing the antibiotic development pipeline with ensuring that clinical trials provide clinically relevant evidence of effectiveness in showing added benefits for the patient.

Further reading: BMJ Medicine
Author(s): Mayookha Mitra-Majumdar et al
Smart Innovations  
Back

OUR UNDERWRITERS

Unrestricted financial support by:

Antimicrobial Resistance Fighter Coalition

Evotec

JSS University

INTERNATIONAL FEDERATION PHARMACEUTICAL MANUFACTURERS & ASSOCIATIONS





Technology Database

Display your AMR Technology, Product and Service

Suppliers and Users of Technologies, Products and Services benefit from CAPI.
CAPI (Continuous AMR Partnering Initiative) unites Suppliers and Users worldwide with the aim to add to the curbing of AMR.

Read more and make your own Technology Page >>
What is going on with AMR?
Stay tuned with remarkable global AMR news and developments!