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News and Press: Industry News

2017 User Fee Schedules Issued by FDA

Friday, July 29, 2016   (0 Comments)
Posted by: Stephen Rapundalo
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FDA announced the FY2017 fee rates and payment procedures for the following products;

·         medical devices

·         prescription drugs

·         biosimilars

·         generic drugs


The Agency can assess and collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. 


Some modest decreases in application fees for FY 2017 may be realized by biopharma and medical device manufacturers when compared to 2016. In some cases, there are provisions for companies with gross receipts or sales of no more than $100 million for the most recent tax year, to qualify for reduced small business fees.


The new FY2017 fee schedules are effective on October 1, 2016 through eptember 30, 2017, when the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), Generic Drug User Fee Act (GDUFA) and Medical Device User Fee Act (MDUFA) will be re-authorized by Congress.

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