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# Stakeholders Make 2016 FDA Predictions
- URL: https://www.fdaweb.com/stakeholders-make-2016-fda-predictions/
- Published: 2016-01-19T12:00:00.000Z
- Updated: 2026-09-15T02:28:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134469

> Stakeholders contacted by *Bloomberg BNA Pharmaceutical Law & Industry Report* have given their [predictions](http://www.wileyrein.com/assets/htmldocuments/CzabanBNAPharmaLaw.pdf?ref=fdaweb.com) about FDA actions likely to occur in a number of important areas in 2016\. Key concerns for biotech companies are cited as reauthorization of drug user fee programs, implementation of the biosimilar drug pathway, drug compounding, and statements about off-label uses of drug products.  
>  
> CDER director **Janet Woodcock** said 12/14 that the Center’s top priorities in 2016 include reauthorization of drug user fee programs and implementing statutory provisions on drug compounding. Other priorities she cited included drug advertising and promotion in light of First Amendment court cases, continuing the plan to build the new Panorama information technology system for a drug review process and other regulatory functions, improving staffing, developing a process and policy documents on the evaluation of a biomarker as a surrogate endpoint for accelerated approval, and working on the final version of the 7/27/15 draft quality metrics guidance.