By Riëtte van Laack – Representative Louise Slaughter (D-NY) recently sent a 4-page letter to FDA expressing her discontent with the Agency’s action (or lack thereof) related to antibiotic use in animal agriculture. Specifically, Rep. Slaughter criticizes: 1. FDA’s delay in finalizing the industry guidance #209, titled the …
By Karla L. Palmer & Jeffrey N. Gibbs – Marking a significant victory for the pharmaceutical compounding industry, a Florida federal district court ruled that FDA did not have authority to enjoin the “long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food …
By Kurt R. Karst – Although many have tried (see, e.g., here), in our experience, few have succeeded in convincing a court to decide to grant a motion to extend a 30-month stay on FDA’s approval of a generic drug application. (The most recent case we …
By Kurt R. Karst – A group of nonprofit organizations has filed a Complaint seeking to compel FDA, by a court-ordered deadline, to withdraw approval for subtherapeutic uses of penicillin and tetracyclines in animal feed and to issue a final response to two Citizen Petitions submitted …
By Wes Siegner – On December 20, 2010 FDA published a notice requesting comments on how the agency can address a “problem” that has existed since the 1960s, when the Federal Food, Drug, and Cosmetic Act ("FDC Act") was amended in to require premarket approval. The problem …
By Riëtte van Laack – The Animal Drug User Fee Amendments of 2008 (“ADUFA”) directs FDA to prepare annual summaries of antimicrobials sold or distributed for use in food-producing animals. The data are derived from information sponsors of new animal drug applications provide to FDA (as …
