PDUFA added the composite pharmacy charging version
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Last Update: 2014-04-04
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Source: Internet
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Author: User
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Source: China Council for the promotion of drugs 2014-04-04 FDA intends to let compound pharmacy provide funds for inspection Regulatory focus (RF) reports that the FDA has released draft guidelines that will allow it to charge compound pharmacies, just as PDUFA fees are used to fund drug reviews RF pointed out that after the scandal of more than 60 deaths in the compound pharmacy, the FDA said it lacked the funds and power to supervise the compound pharmacy, so the legislator approved the fee last autumn The approved act, known as the drug quality and Safety Act, grants FDA oversight of "outsourced facilities." RF reports that the regulatory fee includes an annual "enterprise fee" (small business $5000) of $15000 per year and a re inspection fee of $15000 per year The guide also includes an incentive policy that companies that have completed the registration of outsourced facilities by the end of fiscal year 2014, October 1, do not have to pay the annual fee for that year These companies are only required to pay annual fees from fy15 Original link: http:// guidance for Industry fees for human drug compounding outsourcing facilities under sections 503B and 744k of the FD & C act http:// compliance regulatory information / guidance / ucm391102.pdf
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