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FDA Week - 07/14/2017

Fewer Drugs May Use FDARA Competitive Generic Path Due To Tweak

July 13, 2017
A change requested by FDA to the new generic competitive therapy section in the House user fee package may ratchet back the number of products that move through the new pathway and in the process ease the amount of resources the agency needs to implement it. The new version of the bill says the HHS secretary "may" expedite a drug designated as a competitive generic therapy at the request of an applicant, rather than "shall." The change was made after...


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