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The FDA has issued an International Conference on Harmonisation (ICH) guidance that could help drugmakers win "regulatory flexibility" that potentially includes fewer postapproval submissions and a reduction of end-product release testing.
The FDA is developing guidance on the use of coordinators who are not principal investigators (PI) to improve supervision of multi-site clinical trials, an FDA official has announced.
The FDA intends to improve supervision of multi-site clinical trials by working on a guidance on the use of coordinators who are not principal investigators (PI), an FDA official has announced.
The FDA has issued an International Conference on Harmonisation (ICH) guidance that could help drugmakers win "regulatory flexibility" that potentially includes fewer postapproval submissions and a reduction of end-product release testing.
Sponsors considering pediatric HIV vaccine trials should consult a new FDA guidance, which is also aimed at institutional review boards (IRBs) and clinical investigators.
Sponsors of pediatric clinical trials should consult a newly issued draft FDA guidance that describes how the agency will review proposals for such trials.
The FDA has updated its guidance for real-time premarket approval application (PMA) supplements. The document supersedes and replaces guidance issued in 1997.
The FDA has issued a draft guidance for clinical investigators, institutional review boards (IRBs), sponsors and others concerning the agency’s review process for clinical trials involving children.
The FDA has issued a draft guidance for clinical investigators, institutional review boards (IRBs), sponsors and others concerning the agency’s review process for clinical trials involving children.