Zdrowie i gospodarka · 24/11/2014

FDA Announces Final Guidance on Fees for Human Drug Compounding Outsourcing Facilities

The Food and Drug Administration (FDA) has released a final guidance document outlining the fees required for entities that compound human drugs and register as outsourcing facilities under the FD&C Act, including the annual establishment fee and reinspection fee, and the process for submitting payments and qualifying as a small business.