Saturday, April 19, 2014

April 24th Webinar: CDER Small Business and Industry Assistance (CDER SBIA) to Present Webinar, "Fees Associated with Human Drug Compounding By Registered Outsourcing Facilities"

On Thursday April 24, 2014, at 1 pm EDT, CDER Small Business and Industry Assistance (CDER SBIA) will present a webinar entitled, "Fees Associated with Human Drug Compounding By Registered Outsourcing Facilities." Please note registration is required.
The purpose of this webinar is, "to announce the recently-published human drug compounding fee draft guidance for industry and, in particular, to draw attention to the current open period for small businesses to request a reduction in the required establishment fee. Qualified small businesses pay a fee that is one-third the amount of non-small businesses. The draft guidance covers fee requirements for human drug compounding outsourcing facilities that have elected to register with the FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 503B requires outsourcing facilities to pay certain fees."

Click here for more information.

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