By Kurt R. Karst – We thought Eisai Inc.’s (“Eisai”) beef with FDA over New Chemical Entity (“NCE”) exclusivity might resurface at some point . . . and now it has. Last Friday, Eisai filed a Complaint in the U.S. District Court for the District of …
By James E. Valentine* & James C. Shehan — On August 5, 2014, FDA announced the availability of its most recent biosimilars guidance entitled, “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act” (“FDA Draft Guidance”). The Draft Guidance puts some sponsors …
By Riëtte van Laack — On July 29, 2014, the D.C. Circuit decided that USDA’s Country of Origin Labeling (COOL) regulation passed constitutional muster. Our previous posts regarding this case provide details on the background. Congress required COOL on many foods, including some meat products, and …
By Ricardo Carvajal — FDA is set to start enforcing its gluten-free labeling rule (for our prior posting on the rule, see here). To make sure you didn’t miss the onset of the compliance deadline of August 5, FDA issued reminders in the form of a …
By Jennifer D. Newberger — We previously posted about CDRH’s guidance on the appeals process contained in the Food and Drug Administration Safety and Innovation Act (FDASIA), and its issuance of a draft Q&A discussing section 517A. Section 517A imposed timeframes for appeal decisions that were …
By Allyson B. Mullen & Jeffrey N. Gibbs — On July 31, 2014, in accordance with Section 1143 of the Food and Drug Administration Safety and Innovation Act (FDASIA), FDA notified Congress of its intent to issue two draft guidance documents regarding oversight of laboratory developed tests …
By Kurt R. Karst – “Driveway moments” – most of us have had them. It’s that moment when we feel compelled to stay in the car and finish listening to something on the radio. This blogger recently had such a moment commuting home from work on …
