By Kurt R. Karst – Earlier this year, FDA’s Dallas District Office issued a Warning Letter to Sovereign Pharmaceuticals, LLC (“Sovereign”), a pharmaceutical contract manufacturing facility located in Fort Worth, Texas, containing a rather interesting – and quite perplexing – violation tagged under the heading “Unapproved …
The American Conference Institute (“ACI”) will be holding two events in the coming months that are of particular interest to FDA Law Blog readers. . . . and, importantly, for which our readers can get a discount. The first event is ACI’s Legal, Regulatory, and …
By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
By Kurt R. Karst – A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …
By Kurt R. Karst – By now everyone knows that FDA has appealed to the Second Circuit (Case No. 13-1690) the April 5, 2013 Memorandum and Order and April 10, 2013 Judgment from Judge Edward R. Korman of the U.S. District Court for the Eastern District …
By Etan J. Yeshua & Kurt R. Karst – Last Friday, a federal district court judge, in a 59-page decision, ordered FDA to make the emergency contraceptive PLAN B (levonorgestrel) available Over-the-Counter (“OTC”) and without age restrictions. In doing so, Judge Edward R. Korman of …
By Kurt R. Karst – Earlier this week, the U.S. Court of Appeals for the Second Circuit issued a decision that paves the way for the Natural Resources Defense Council (“NRDC”) to pursue its action to compel FDA to finalize the Agency’s review and regulation …
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
By Kurt R. Karst – Every few years, interest in the creation of a third category of drug products – something other than prescription or Over-the-Counter (“OTC”) status – is piqued by FDA, Congress, or by some other entity. The most recent attempt to explore the …
By Ricardo Carvajal – Several nonprofit groups sued FDA for its failure to respond to a May 2006 citizen petition asking that products of nanotechnology be subject to specific regulatory requirements, and that FDA stop the marketing of sunscreens that contain nanoparticles. The complaint alleges that …
By Susan J. Matthees – The National Advertising Division (“NAD”) of the Council of Better Business Bureaus recently concluded that claims that Procter & Gamble’s Crest Sensitivity Treatment & Protection Toothpaste could provide relief from sensitive teeth “within minutes” should be discontinued. Colgate-Palmolive brought the challenge …
By Susan J. Matthees – FDA recently denied a 2006 citizen petition submitted by Wyeth Consumer Healthcare (“Wyeth”) requesting that FDA withdraw a 2005 Notice of Proposed Rulemaking (“NPRM”) that would reclassify phenylpropanolamine (“PPA”) from Category I (generally recognized as safe and effective) to Category II (not …
By Kurt R. Karst – Over the Independence Day holiday, in between the family BBQ and fireworks, we had a few minutes to reflect on what a hectic month June was for FDA and the regulated industry. There were the decisions handed down by the U.S. …
By Susan J. Matthees – On Tuesday, sunscreen finally stepped out of the shadows at FDA. After years waiting, FDA announced the availability of a number of new documents related to over-the-counter (“OTC”) sunscreen drug products marketed in the US, including a guidance document on enforcement …
By Kurt R. Karst – On January 24th, the U.S. Court of Appeals for the Ninth Circuit issued its decision in Gaeta v. Perrigo, reversing a decision from the U.S. District Court for the Northern District of California (San Jose Division) that Plaintiff-Appellant Gaeta’s state law …
