February 3, 2017
Last month, FDA’s Center for Drug Evaluation and Research (CDER) released its annual guidance agenda, announcing the new and revised draft guidances that the Center plans to publish during the 2017 calendar year. CDER’s agenda is organized by category and touches on a variety of topics, giving us a glimpse of what to expect throughout the year.
This year’s agenda follows a similar pattern to the Center’s 2016 agenda, placing an emphasis on the clinical aspects of drug development, pharmaceutical quality, generics, and procedural activities. Specifically, CDER plans to publish the following draft guidance documents during 2017:
It is important to note that this list outlines the documents that CDER is planning on publishing throughout the year. CDER is not bound by this list of topics, required to issue a guidance on every topic included in the list, or precluded from developing guidance on topics not included in the list.
January 27, 2016
On Friday, January 22, FDA’s Center for Drug Evaluation and Research (CDER) published its 2016 guidance agenda. The guidance agenda is published on an annual basis and announces the draft guidances...
October 29, 2015
Published on October 27, 2015, the guidance document outlines a number of recommendations for the nonclinical evaluation of previously approved drug substances when a new formulation or a new route...
October 19, 2015
On Wednesday, October 13, 2015, FDA released a draft guidance entitled “Recommendations for Microbial Vectors Used for Gene Therapy.” The document provides information and recommendations regarding...