By Kurt R. Karst – The first iteration of the Generic Drug User Fee Amendments (“GDUFA”) – “GDUFA I” – is now well into Year 4 of the 5-year program, and anticipation is growing as to what the second iteration of the program – “GDUFA II” …
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Hyman Phelps McNamara
- RLD Designation Citizen Petitions: One Item on Our GDUFA II Wish ListMay 18th, 2016
- FDA Finalizes Postmarket Device Surveillance GuidanceMay 17th, 2016
By McKenzie E. Cato* & Allyson B. Mullen – On May 16, FDA issued its final guidance document on postmarket surveillance of medical devices, “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act,” approximately five years after issuing the draft guidance. The …
- HP&M Publishes Comprehensive Deskbook on FDA Compliance and EnforcementMay 16th, 2016
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 …
- FDA Issues Final Guidance for Medical Foods Largely Ignoring CommentsMay 16th, 2016
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 As we previously reported, in August 2013, FDA issued a draft guidance, updating the 2007 guidance for medical foods.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 …
- Congress’ Dubious Delegation of Legislative Authority to USP Standards Results in “Instructions”– But Not “Dismissal” – Related to the NECC Criminal IndictmentMay 12th, 2016
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 …
- Texas Finalizes Repeal of Medicaid Price Reporting RequirementMay 12th, 2016
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 …
- ACI & CRN Co-Sponsor Forum on Dietary SupplementsMay 12th, 2016
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 …
- FDA Issues Much Anticipated Draft Guidance on Additive Manufactured (“3D-Printed”) DevicesMay 11th, 2016
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 …
- FDA’s Final Deeming Regulations Covers all “Tobacco Products”May 10th, 2016
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 …
- FDA Certitudes: The Creation of an OTC Drug Monograph User Fee ProgramMay 10th, 2016
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” …
- HP&M Seeks Alternative Statutory Reading of BPCI Act “Deemed to be a License” ProvisionMay 9th, 2016
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 …
- FDA Revises Guidance on Special Protocol Assessments, Attempts to Reduce UncertaintyMay 9th, 2016
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 …
- FDA Sets Enforcement Date for Restaurant Menu (and Coupon!) LabelingMay 5th, 2016
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 …
- FDA Finalizes Compliance Policy Guide: Pet Food Diets Intended for Sick Animals are Drugs but FDA will Exercise Enforcement Discretion under Limited CircumstancesMay 5th, 2016
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. …
- Speculating About the Prospects of Exclusivity – A Potentially Risky GameMay 5th, 2016
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 …