Clinical Research Solutions
On April 19, 2016, FDA released a revised and updated draft guidance entitled "Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information," which...
Clinical Research Solutions
On Tuesday, April 5th, FDA announced the approval of Inflectra™ (infliximab-dyyb), a biosimilar version of Janssen Biotech's Remicade® (infliximab), for a number of indications. Inflectra is...
Clinical Research Solutions
According to an infographic report from the California Life Sciences Association (CLSA), FDA approval times have decreased by nearly 50% since 2009. The infographic, entitled “Tracking FDA Drug...
Clinical Research Solutions
On Wednesday, March 30th, FDA approved a new label for Mifeprex® (mifepristone), the medical abortion pill. The FDA stated that the drug is both safe and effective when taken in lower doses and up to...
Clinical Research Solutions
On Monday, March 28th the FDA announced that it is amending its current IND and bioequivalence regulations. Specifically, FDA stated that it is changing “its regulations to update the address for...
Clinical Research Solutions
On February 1, 2016, the Biosimilars Forum, a nonprofit organization dedicated to increasing biosimilar access in the US, announced the launch of “Partnership for Biosimilar Education and Access,” a...
Clinical Research Solutions
On November 3, 2015, Tufts Center for the Study of Drug Development (CSDD) published its November/December Tufts CSDD Impact Report. According to the report, when “first-in-class” drugs receive...
Clinical Research Solutions
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...
Clinical Research Solutions
FDA’s priority review voucher program allows drug makers to receive expedited review of drug products intended to treat rare or neglected diseases (more details in our blog post here). The program...
Clinical Research Solutions
Sandoz, the generic pharmaceuticals division of Novartis, is the global leader in biosimilar products. On March 6, 2015, FDA approved Zarxio, a biosimilar version of Amgen’s Neupogen (filgrastim)...