6/19/2013 5:30:00 PM
Due to summer holidays, Clinical Trials Advisor will not be published July 4. The next issue will be published July 18.
6/19/2013 5:30:00 PM
The FDA June 12 published a list of proposed “qualified pathogens” it believes most endanger the public and might be eligible for qualified infectious disease product (QIDP) designation under the GAIN Act provisions of the FDA Safety and Innovation Act.
6/19/2013 5:30:00 PM
The FDA has released final guidance on codevelopment of two or more investigational drugs. Taking heed of industry comments, the document expands the definition of “codevelopment” and clarifies criteria for when codevelopment is an appropriate development option.
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