FDA Ponders Whether To Publicly Discuss Pending NDAs And INDs; Should Agency Reply To Studies Published In Journals?
FDA leadership is considering whether, and to what extent, the agency should be able to publicly discuss INDs, drug applications and complete response letters
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HONG KONG - Multinational pharmaceutical companies may start submitting for publication the results of more clinical trials, whether they are successful or not, as part of a new set of principles endorsed by industry associations around the world
More transparency could help Freedom of Information Act process, FDA Deputy Commissioner Sharfstein suggests.
Jenkins Suggests "Complete Response" Letter Transparency Could Prompt Better Drug Applications, Faster Reviews
If FDA's transparency initiative results in the public release of "complete response" letters, Office of New Drugs Director John Jenkins sees a possible side benefit for the agency