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 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 …
By Alan M. Kirschenbaum – The October 30, 2015 Texas Register contained a proposed regulation published by the Health and Human Services Commission (HHSC) that would repeal a burdensome price reporting requirement for drug manufacturers. In order to have a drug included on the Texas fee-for-service …
By Kurt R. Karst – There are several important dates in the history of the Orange Book – FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations – some of which are the result of advancements in technology, and some of which occur (curiously) around the end …
By Riëtte van Laack – As we previously reported, POM Wonderful (“POM”) petitioned the U.S. Court of Appeals for the D.C. Circuit for en banc review of that Court’s earlier decision which had largely upheld the FTC’s cease and desist order issued against POM. That petition was …
By Ricardo Carvajal – FDA has established a web page that “alerts consumers to companies fraudulently marketing products for the treatment or prevention of serious diseases.” If a company receives a warning letter challenging such claims and fails to correct its marketing practices within 30 days, …
By Kurt R. Karst – Earlier this week FDA finally released its Manual of Policies and Procedures (“MAPP”) on NDA Classification Codes (MAPP 5018.2) – formerly called “Chemistry Classification Codes.” The MAPP has been under development for quite some time . . . . and there’s …
By Wes Siegner – Effective October 30, 2015, FDA issued a stay on certain food provisions of the final guidance, “Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an IND” (IND Guidance). FDA announced the stay in the Federal Register notice, 80 …
FDA recently announced that it has submitted the FSMA final rules on produce safety, foreign supplier verification, and third party accreditation to the Federal Register – just in time for the third and fourth installments in the Food and Drug Law Institute’s (FDLI’s) FDA Food Safety …
By Jeffrey K. Shapiro – For more than 10 years, FDA has regulated human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) under 21 C.F.R. Part 1271. Under § 1271.10(a), if four criteria are met, the HCT/P qualifies for regulation exclusively under Part 1271. This status …
By Diane B. McColl – On October 28, 2015, FDA announced that a food additive petition (FAP) submitted by the Grocery Manufacturers Association (GMA) for minor uses of partially hydrogenated vegetable oils (PHOs) was accepted for filing on October 1, 2015 (Docket No. FDA-2015-F-3663). GMA’s FAP …
