Search Results for: scot pittman

On July 29, 2016, President Barack Obama signed S.764 into law. The law amends the Agricultural Marketing Act of 1946 to require that the U.S. Department of Agriculture (“USDA”) establish and oversee a national bioengineered food disclosure standard. Under the law, USDA has two years to promulgate regulations that establish the disclosure standard, as well […]

Frommer Lawrence & Haug LLP is proud to announce that the Food and Drug Law Institute (“FDLI”) just published the FDLI Primer, “The Drug/Biologics Approval Process” authored by FLH Partner Brian J. Malkin and Associate Scot Pittman. Mr. Malkin has been a member of the Primer Committee for several years now. Recently, FDLI decided to […]

by Scot Pittman This coming Friday, December 16, 2011, the Food and Drug Administration will hold a public meeting to discuss and solicit comments regarding its December 7th Federal Register Notice titled “Proposed Recommendations for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017.” This proposal is […]

by Scot Pittman On Monday, the Supreme Court heard oral argument in Caraco Pharm. Labs. Ltd. v. Novo Nordisk A/S (previously discussed here and here) to decide whether a generic drug manufacturer can use the counterclaim provisions of the Hatch-Waxman Act, as amended by the 2003 Medicare Prescription Drug Improvement and Modernization Act, to require […]

by Scot Pittman Hill Dermaceuticals, Inc. has sued the Food and Drug Administration in the District Court for the District of Columbia over the approval of three Abbreviated New Drug Applications (“ANDAs”) submitted by Identi Pharms, Inc. Hill seeks the immediate withdrawal or suspension of FDA’s approval of the alleged generic equivalents to Hill’s Derma-Smoothe/FS® […]

by Scot Pittman FDA has put forth significant efforts in trying to tweak its 510(k) device approval pathway, which has created discontent among medical device companies for many years. In its most recent attempt to improve the medical device approval process, FDA released draft guidelines “De Novo Classification Process (Evaluation of Automatic Class III Designation)” […]

by Scot Pittman A recently released draft, five-year plan from the FDA includes procedures aimed at increasing the Agency’s involvement in the area of orphan diseases. Rare, or orphan, diseases are those that affect less than 200,000 people in the United States; but with more than 7,000 known rare diseases, they are anything but rare […]

For those parties required to submit patent information to the U.S. Food and Drug Administration, the Agency has published updated forms: Form 3542 and Form 3542a.  FDA updated the patent information forms as part of final regulations implementing portions of the 2003 Medicare Modernization Act.  The regulations, which FDA issued on October 6, 2016, took […]

Last week, the U.S. Food and Drug Administration published the Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022.  Commonly referred to as the “goals letter” or “commitment letter,” the publication represents discussions among FDA, the regulated industry, and public stakeholders regarding reauthorization of the Biosimilar User Fee Act (“BsUFA”).   […]

Editors: Charles J. Raubicheck Andrew S. Wasson Authors: Caroline Bercier Laura A. Chubb Leann M. Clymer Benjamin I, Dach, Ph.D. Laura Fanelli Russell A. Garman, Ph.D. Christopher Gosselin Blaine Hackman, Ph.D. Michael W. Harkness Jason A, Kanter Richard F. Kurz Erin A. Lawrence Alyse P. Mauro1 Rachael P. McClure Kate Mead3 Elizabeth Murphy Eric Nielson3 […]