By Kurt R. Karst – The U.S. Patent and Trademark Office (“PTO”) has finally issued a final decision in the long-running dispute over eligibility for a Patent Term Extension (“PTE”) for U.S. Patent No. 5,674,860 (“the ‘860 patent”) covering AstraZeneca LP’s SYMBICORT (budesonide and formoterol fumarate …
By Kurt R. Karst – FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (“GDUFA”) and adherence to the triad of key aims laid out in the accompanying Performance Goals and Procedures – Safety, Access, and Transparency – have been a bit of a …
By JP Ellison – In a speech on January 29th at the CBI Pharmaceutical Compliance Congress that DOJ posted on its own website, U.S. Department of Justice Assistant Attorney General Stuart Delery set forth his views of the three ways that the government’s enforcement interests align with …
By Delia A. Deschaine – Various members of industry recently joined together in filing a citizen petition with FDA. Citizen Petition, Docket No. FDA-2013-P-1711 (hereinafter “Citizen Petition”). The Citizen Petition responds to a statement made by CDER Director, Janet Woodcock, M.D. in October 2013 that FDA intends …
By Riëtte van Laack – On December 26, FDA sent Warning Letters (here and here) to Accera, Inc. and NVN Therapeutics. Accera Inc. markets a product, Axona, as a medical food “for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s …
Biosimilars (or follow-on biologics) are a hot topic these days – and getting hotter – whether one talks about FDA’s draft guidance documents (see here), battles brewing in state legislatures around the country concerning substitution (see here), the flurry of citizen petitions submitted to FDA …
By Ricardo Carvajal – The Institute of Medicine (“IOM”) published a summary report of the workshop on caffeine in food and dietary supplements that IOM convened last August at FDA’s request. As noted in the introduction to the summary, the summary presents statements, recommendations, and opinions …
By Jeffrey K. Shapiro – FDA has issued a new draft guidance on the custom device exemption. Comments are due by March 17, 2014. This schedule puts FDA on track to finalize the guidance by July 9, 2014, as required under section 617 of the Food and …
By Anne K. Walsh – While the mid-Atlantic region was paralyzed under 4 to 8 inches of snow, it was business as usual for the Tenth Circuit Court of Appeals in Colorado. On January 21, 2014, the court issued an opinion affirming the felony conviction of John …
By Kurt R. Karst – In a Januarry 22, 2014 letter to FDA Commissioner Margaret Hamburg, M.D. signed by 28 members of Congress, lawmakers express “grave concerns” about FDA’s November 2013 proposed rule to allow generic drug manufacturers to independently update product labeling (with respect to …
By Kurt R. Karst – In a notice that will appear in the Federal Register later this week, FDA is announcing the establishment of a public docket (Docket No. FDA-2014-N-0032) to receive input and suggestions on ways to improve the quality of ANDAs (original, amendments, and …
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 …
