The FDA Law Blog is pleased to announce the release of the FDA Deskbook, prepared by the attorneys at Hyman, Phelps & McNamara, P.C., the same authors who provide the expertise and analysis contained in this blog. The FDA Deskbook is a complete resource on …
By Riëtte van Laack – FDA announced the availability of the Final Guidance for Medical Foods: “Frequently Asked Questions About Medical Foods; Second Edition.” As we previously reported, in August 2013, FDA issued a draft guidance, updating the 2007 guidance for medical foods. In the 2013 draft …
By Karla L. Palmer – A Massachusetts United States district court judge decided last week whether the United States’ reliance on alleged violations of the United States Pharmacopeia (“USP”) compendium addressing sterility of compounded preparations was a permissible delegation of legislative power to USP to define …
By Alan M. Kirschenbaum – Last October we reported on a proposed regulation published by the Texas Health and Human Services Commission (HHSC) to repeal a burdensome price reporting requirement for drug manufacturers under Texas Medicaid. HHSC has now finalized the proposed rule without change. See Texas …
The American Conference Institute’s 4th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements will be presented in collaboration with the Council for Responsible Nutrition, and is scheduled for June 27-28 in New York. The Forum will feature presentations on policy initiatives, federal and state …
By McKenzie E. Cato* & Allyson B. Mullen – On May 10, FDA issued the long-awaited draft guidance, “Technical Considerations for Additive Manufactured Devices.” In October 2014, FDA held a public workshop on AM devices, “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical …
By David B. Clissold – On May 10, 2016, FDA published in the Federal Register the final “deeming regulation” asserting control over all tobacco products, even products that do not yet exist, meeting the broad statutory definition of a “tobacco product.” Under the Family Smoking Prevention …
By Kurt R. Karst – There are general life certitudes, such as the quote attributed to Benjamin Franklin: “In this world nothing can be said to be certain, except death and taxes.” There are also FDA certitudes we’ve come to recognize. For example, “everything eventually goes generic” …
By James E. Valentine & Josephine M. Torrente – In March, FDA published a draft guidance document that describes FDA’s approach to the implementation of the statutory provision in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) under which an …
By James E. Valentine & Alexander J. Varond – FDA recently issued draft guidance, entitled “Special Protocol Assessment,” which, when finalized, will replace FDA’s 2002 final guidance by the same title. At 23-pages long, the draft guidance is much more thorough than its predecessor (only 11 …
By Etan J. Yeshua – Today, FDA officially announced the availability of a final guidance document that answers questions about the Agency’s menu labeling rule. In doing so, FDA also set May 5, 2017 as the rule’s enforcement date. Although there are only a few differences …
By Riëtte van Laack & Wes Siegner – Under the FDC Act, dog and cat food products that are intended to treat or prevent disease and to provide nutrients in support of the animal’s daily nutrient needs can be regulated as drugs or foods or both. …
By Kurt R. Karst – Speculating about the prospects that FDA will grant a period of marketing exclusivity – 5-year New Chemical Entity (“NCE”) exclusivity, 3-year new clinical investigation exclusivity, 7-year orphan drug exclusivity, or any other type of exclusivity or add-on exclusivity – upon the …
By Anne K. Walsh – A drug or device company (or its officers, management, or employees) who are the target of a False Claims Act lawsuit or investigation face the potential threat of being excluded from Medicare, Medicaid, and other Federal health care programs. For a …
By Riëtte van Laack – Last year (October 2015), POM Wonderful LLC (POM) petitioned the U.S. Supreme Court for review of the decision of the U.S. Court of Appeals for the District of Columbia (see our previous post here). As we discussed, POM’s arguments in its …
