GAIN has encouraged FDA to be flexible on data requirements for antibiotics, according to sponsors.
The environment for antibiotics development became a friendlier place for sponsors in 2013 with FDA’s implementation of the Generating Antibiotic Incentives Now (GAIN) Act, but just how much the economic incentives of GAIN will change the antibiotics landscape will become clearer in 2014.
The agency’s list of GAIN activities in 2013 included a proposed list of pathogens that have the potential to pose...
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
