By Riëtte van Laack – In 2002, FDA issued regulations providing for a process, the Time and Extent Application (TEA), to create a new Over-the-Counter (OTC) drug monograph or amend an existing monograph to recognize that an active ingredient or condition (e.g., dosage form) is Generally …
Earlier this week we received an email from the editors of the American Bar Association (“ABA”) Journal announcing that Hyman, Phelps & McNamara, P.C.’s FDA Law Blog was selected to the 2015 (and 9th annual) ABA Blawg 100. The Blawg 100 is a list of …
As combination products continue to increase in number and complexity, FDA has shifted its focus to developing more effective ways to review them. While FDA has strived to clarify regulatory requirements and coordinate product reviews among the various centers, it is often difficult to know …
By Ricardo Carvajal – In tandem with its approval of genetically engineered (GE) salmon (see our previous post here), FDA issued two guidance documents on labeling of GE foods – a final guidance document applicable to foods derived from GE plants, and a draft guidance document specific to GE …
By Anne K. Walsh & John R. Fleder – As we reported in September, DOJ’s Deputy Attorney General Sally Quillian Yates released a seven-page memorandum announcing DOJ’s reinforced efforts to bring cases against individuals. She anticipated that DOJ would revise the U.S. Attorney’s Manual (USAM) to …
By Jay W. Cormier – At long last, yesterday FDA approved AquaBounty’s AquAdvantage Salmon. The approval includes a number of related actions from FDA. As part of the approval, and as required by the National Environmental Policy Act (NEPA), FDA issued a Finding of No Significant Impact …
This January, the American Conference Institute (“ACI”) will hold a forum to discuss the rapidly evolving legal and regulatory space for promotion of drugs and devices. The two-day meeting (with an opportunity for an extra half-day mock PRC) will be held in Philadelphia, Pennsylvania beginning …
By Riëtte van Laack – In 2013, FDA issued a final rule defining criteria for the term gluten-free for purposes of food labeling. The rule was “incomplete” because it did not address how to test fermented, hydrolyzed and distilled foods for compliance with the rule. In 2013, …
By Kurt R. Karst – In case you were under the impression that FDA’s interest in unapproved drug issues and the Agency’s broader Unapproved Drugs Initiative has been waning, or that the extent of FDA’s interest has merely been in sending out Warning Letters to companies …
The latest issue of the Food and Drug Law Institute’s “Update” magazine features an article written by Hyman, Phelps & McNamara, P.C. attorneys John A. Gilbert, Jr. and Andrew J. Hull. The article, titled “A Matter of Substantial Discretion: A Recent Rift Between DEA and …
By Ricardo Carvajal - FDA released pre-publication versions of the three final rules on foreign supplier verification program (FSVP), accredited third-party certification, and produce safety. As with the recently issued rules on CGMPs and preventive controls for human and animal food (see our previous post here), FDA …
By David B. Clissold – On November 10, 2015, FDA announced that for the first time it has authorized the marketing of new tobacco products through the premarket tobacco application (PMTA) pathway. The FDA press release describes marketing orders for eight Swedish Match North America, Inc. …
By Anne K. Walsh & John R. Fleder – It has been just over a month since the Department of Justice, via the “Yates Memorandum,” reemphasized its commitment to pursue individuals when dealing with corporate misconduct, reported here. Ever since then, FDA-regulated industry has been awaiting …
By John A. Gilbert, Jr. & Larry K. Houck – Yes, with passage of the State Marihuana (sic) and Regulatory Tolerance (“SMART”) Enforcement Act. The bill, H.R. 3746, introduced by Representative Suzan DelBene (D-WA), would authorize the Attorney General to waive the marijuana provisions of the …
By Ricardo Carvajal – FDA is publishing a Federal Register notice asking for information and comments on the use of the term “natural” in human food labeling, “including when, if ever, the use of the term is false or misleading.” The notice purports to be based partly on …
