Federal Register Notice: FDA makes available a draft guidance entitled E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric...
Mintz Levin attorneys summarize five important themes from an FDA hearing on appropriate regulation of off-label communication.
FDA warns CP Pharmaceuticals about CGMP violations in its manufacture of finished pharmaceuticals.
FDA posts a guidance on Safety Testing of Drug Metabolites that provides recommendations to industry on when and how to identify and characterize drug...
The International Probiotics Association petitions FDA asking that it amend its to require the quantitative amount of probiotic ingredients in a dieta...
FDA sends Antera Therapeutics an untitled letter due to promotional claims on the companys Web site that make Aralyte Starter Kit an unapproved biolog...
Federal Register Notice: FDA makes available a guidance entitled Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues...
Sanofi Pasteur decides to discontinue making TheraCys (BCG live attenuated), indicated for treating non-muscle invasive bladder cancer.