CDER SBIA Update: User Fee Payment System Maintenance and More

New Information from FDA: User Fee Payment System Maintenance and More

1. User Fee Payment System Maintenance Extended until January 11th

The FDA User Fee System will be temporarily unavailable from 12:00 AM EST on Friday, January 1, 2016 to 8:00 AM EST on Monday, January 11, 2016 while we upgrade our system.  You will not be able to access the system or submit electronic payments during this time.  You can continue to make offline payments (check and/or wire transfer payments) using the instructions from your cover sheet, invoice, or notice from the FDA. 

We apologize for any inconvenience.  Please contact userfees@fda.gov if you have any questions.

Updated information is posted at http://www.fda.gov/ForIndustry/UserFees/default.htm

2. Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph

FDA is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both prescription and nonprescription fixed-combination and co-packaged drugs and combinations of active ingredients under consideration for inclusion in an over-the-counter (OTC) monograph. These products must meet specific evidentiary requirements for approval. The proposed revisions would harmonize the requirements for prescription and nonprescription products and make them consistent with long-standing Agency policy.

Federal Register Notice

3. Draft Guidance for Industry; Draft Guidance for Industry on Advancement of Emerging Technology Applications To Modernize the Pharmaceutical Manufacturing Base

This guidance document provides recommendations to pharmaceutical companies interested in participating in a program involving the submission of chemistry, manufacturing, and controls (CMC) information containing emerging manufacturing technology. The program is open to companies that intend the technology to be submitted as part of an investigational new drug application (IND), or an original or supplemental new drug application (NDA), abbreviated new drug application (ANDA), or biologics license application (BLA) reviewed by the Center for Drug Evaluation and Research (CDER), where that technology meets certain criteria described in the guidance.

Federal Register Notice

Draft Guidance Document