By Wes Siegner – On September 18, we alerted food researchers that FDA had added new language to a final IND guidance that would require FDA approval of an investigational new drug application (IND) for many food studies now conducted without the burden of filing an IND, …
By Riëtte van Laack – On January 13, FDA announced the availability of two guidances concerning beverages and liquid dietary supplements: “Distinguishing Liquid Dietary Supplements from Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements.” Both guidances are derived from FDA’s 2009 …
By Jeffrey N. Wasserstein & Delia A. Stubbs – For years, those of us who followed FDA’s attempt to provide guidance related to social media felt like Vladimir and Estragon from Samuel Beckett’s Waiting for Godot. FDA initially promised guidance by the end of 2010. But, …
By Kurt R. Karst – It’s been quite some time since FDA established a public docket soliciting comment on an ANDA approval/Hatch-Waxman issue. But FDA revived the process earlier this week when the Agency issued a “Dear NDA/ANDA Applicant” letter (Docket No. FDA-2014-N-0087) concerning approval of …
By Kurt R. Karst – FDA’s Office of Orphan Products Development (“OOPD”) recently revised its Standard Operating Procedures and Policies (“SOPP”) concerning review of orphan drug designation requests to provide the Office’s policies on designating products for two diseases: scleroderma and pulmonary hypertension. The second version …
By Kurt R. Karst – So much of what we do and think about each day inevitably leads us back to one topic: Hatch-Waxman. Take, for example, Polar Vortex 2014. That recent event got us thinking about two things: Snowmageddon 2011, and how warm we hope …
By Jennifer D. Newberger – On January 10, 2014, FDA issued a final rule amending the PMA regulations to require inclusion of information relating to pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure, and the …
By JP Ellison – We previously reported that Pom Wonderful had sought Supreme Court review of the 9th Circuit’s decision that POM’s labeling-based claims against Coke’s Minute Maid products could not proceed under the Lanham Act because such labeling was the province of the FDA and the …
By Delia A. Stubbs – Pursuant to 21 U.S.C. § 811(h), DEA may temporarily place substances in Schedule I of the List of Controlled Substances upon a finding that such action is necessary to avoid an imminent hazard to public health and safety. Using that authority, …
By Riëtte van Laack – On January 7, the FTC announced an initiative “Operation Failed Resolution” stating that it wants to protect consumers against deceptive weight loss claims. Among other things, the FTC announced actions against four companies for advertising fad weight-loss products, issued an updated …
By Kurt R. Karst – With primary briefing over (briefs here, here, and here), and a December 13, 2013 Oral Argument before Judges Griffith, Kavanaugh and Randolph concluded, we were waiting with bated breath for the U.S. Court of Appeals for the District of Columbia Circuit …
By Karla L. Palmer – FDA Commissioner Margaret A. Hamburg, M.D., sent open letters (here and here) to “Hospital Purchasers” and state officials including governors, state boards of pharmacy and health departments, informing them of the passage of the Drug Quality and Security Act (Public Law 113-54,127 …
By Ricardo Carvajal – As we noted in a prior posting, several courts have stayed or dismissed class actions based on the doctrine of primary jurisdiction in cases that raise the question of whether a GMO-containing food can properly be labeled as “natural.” In response to …
By Ricardo Carvajal – In the latest major rulemaking initiative under the Food Safety Modernization Act ("FSMA"), FDA issued a proposed rule to implement provisions of FSMA that address intentional adulteration. Further below we summarize major provisions of the proposed rule. However, we note at the outset …
By Kurt R. Karst – Sandoz Inc. (“Sandoz”) is appealing to the U.S. Court of Appeals for the Federal Circuit (Docket No. 14-1693) a November 2013 decision from the U.S. District Court for the Northern District of California granting Amgen Inc.’s (“Amgen’s”) and Hoffmann-La Roche Inc.’s …
