jueves, 3 de agosto de 2017

Antibacterial Therapies for Serious Bacterial Diseases/ Child-Resistant Packaging/ Outsourcing Facility Fee Rates

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
1. Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases; Guidance for Industry
FDA has released this guidance to assist sponsors in the clinical development of new antibacterial drugs. Specifically, the guidance explains the FDA’s current thinking about possible streamlined development programs and clinical trial designs for antibacterial drugs to treat serious bacterial diseases in patients with an unmet medical need, including patients who have a serious bacterial disease for which effective antibacterial drugs are limited or lacking.  Antibacterial drugs that are pathogen-focused can be developed for the treatment of serious bacterial diseases in patients who have an unmet medical need.
2. Child-Resistant Packaging Statements in Drug Product Labeling
This guidance is intended to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging (CRP) statements in their drug product labeling. It discusses what information should be included to support CRP statements in labeling for new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license applications (BLAs), and supplements to these applications. In addition to recommendations for labeling of prescription drug products, this guidance also includes recommendations for labeling both for nonprescription drug products approved under an NDA or ANDA and those that are marketed under the Over-the-Counter Drug Review. This guidance is intended to help ensure that such labeling is clear, useful, informative, and, to the extent possible, consistent in content and format.
3. Outsourcing Facility Fee Rates for Fiscal Year 2018
The FDA is announcing the fiscal year 2018 rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act, which authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities, as well as a re-inspection fee for each re-inspection of an outsourcing facility. This document establishes the FY 2018 rates for the small business establishment fee ($5,364), the nonsmall business establishment fee ($17,364), and the re-inspection fee ($16,093) for outsourcing facilities; provides information on how the fees for FY 2018 were determined; and describes the payment procedures outsourcing facilities should follow. These fee rates are effective October 1, 2017, and will remain in effect through September 30, 2018.

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