CDER Seeks Site Visit Proposals for FY 2019 Learning Program

The US Food and Drug Administration called on pharmaceutical companies on Thursday to submit site visit proposals for FY 2019 as part of a voluntary learning program for agency staff.
 
The Staff Experiential Learning Site Visit (ELSV) Program—first announced in 2016—aims to provide staff at the Office of Pharmaceutical Quality within FDA’s Center for Drug Evaluation and Research (CDER) new learning opportunities with in-person visits to drug manufacturing sites.
 
In a Twitter thread on Thursday, FDA Commissioner Scott Gottlieb highlighted the program's objectives.

To do this, we’re announcing the 4th year of the voluntary Experiential Learning Site Visit (ELSV) program to provide our staff with an in-person understanding of the industry, its operations, and challenges that impact a drug’s development and life cycle. https://t.co/X9FQ4EJ4u0

— Scott Gottlieb, M.D. (@SGottliebFDA) August 23, 2018

We encourage companies engaging in the development and manufacturing of both active pharmaceutical ingredients and finished drug products to respond for FY 2019. Full criteria for entry and notable dates for the program can be found here: https://t.co/X9FQ4Ert5q

— Scott Gottlieb, M.D. (@SGottliebFDA) August 23, 2018

The current four main areas of interest to FDA staff include drug products; active pharmaceutical ingredients manufactured by chemical synthesis, fermentation or biotechnology; design, development, manufacturing and controls; and emerging technologies. Specific topics include modified and immediate release formulations, drug-device combination products, continuous manufacturing and 3D-printing, according to Thursday's notice.

FDA’s notice also details the information that should be provided in each ELSV proposal, including proposed agendas on learning objectives and dates for each agency site visit.