By William T. Koustas & John R. Fleder – FDA-regulated businesses are certainly closely regulated by FDA and other federal agencies. However, one area that many of these businesses erroneously believe does not affect them is the federal laws and regulations that apply to identity theft. The …
By David B. Clissold & Ricardo Carvajal – In an unusually open-ended request, FDA is asking “all interested parties to provide information and share views” on FDA’s implementation of the Family Smoking Prevention and Tobacco Control Act ("Tobacco Act"), which was signed into law on …
FDA recently launch a redesigned website that is aimed at improving the “look and feel” of all FDA websites. According to the Agency: The new site organization is intended to allow you to find information more quickly: Information is categorized by topic for easier retrieval, with …
By Michelle L. Butler – On May 20, 2009, the President signed the Fraud Enforcement and Recovery Act of 2009 (“FERA”), which is purported to be aimed at improving enforcement of fraud, including fraud related to Federal assistance and relief programs. Among other things, this …
By JP Ellison – We previously reported on the President’s FOIA Memorandum and the Attorney General’s FOIA Guidelines encouraging discretionary disclosure. Today, the D.C. Circuit handed the Administration a FOIA win that shows the importance of such discretionary disclosures, given FOIA’s exemptions. In CREW v. …
By John R. Fleder – On May 5, 2009, the White House announced that President Obama intends to nominate former South Carolina State Superintendent of Education Inez Moore Tenenbaum as Chair of the United States Consumer Product Safety Commission (“CPSC”) and also University of North Carolina …
By John R. Fleder – On April 28, 2009, the United States Supreme Court issued an important ruling on an administrative law issue. In FCC v. Fox Television Stations, the Court by a 5-4 vote ruled that the FCC had properly explained its decision that …
By JP Ellison & John R. Fleder – The Supreme Court’s April 22, 2009 decision in NKEN v. HOLDER relates to expediting the removal of aliens from this country. The decision merits mention here because it preserves the ability of appellate courts to stay government action pending …
By Ricardo Carvajal & John R. Fleder – On April 17, 2009, DOJ’s Office of Information Policy (“OIP”) issued guidance to federal agencies on President Obama’s FOIA Memorandum of January 21st and Attorney General (“AG”) Holder’s subsequent FOIA March 19th guidelines. The President’s FOIA memorandum directed …
By Kurt R. Karst – On April 14, 2009, the Federal Trade Commission (“FTC”) announced that Chairman Jon Leibowitz has appointed six senior new staff members, including former Public Citizen Director David C. Vladeck. According to the FTC announcement: David C. Vladeck, who will serve as Director …
By Ricardo Carvajal – FDA has announced a collaboration with the Alliance for NanoHealth ("ANH") that will aim to “expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered …
By David B. Clissold – It seems likely that the answer will be “yes.” The Family Smoking Prevention and Tobacco Control Act (H.R. 1256) is on a fast-track under the new administration. The bill passed the House Energy and Commerce Committee by an overwhelming margin …
When Hyman, Phelps & McNamara, P.C. launched the FDA Law Blog 2 years ago today – Is that 14 in “blog years”? It certainly seems like it, if not more! – we could hardly imagine how successful it would become and how our subscribers (and the …
By Cassandra A. Soltis & Alan M. Kirschenbaum – Today the Obama Administration released a summary of its 10-year budget proposal entitled “A New Era of Responsibility – Renewing America’s Promise.” The document provides a high level outline of priorities – details reportedly will be released in April. …
By Michelle L. Butler – With the effective date for a number of requirements imposed by the Consumer Product Safety Improvement Act (“CPSIA”) quickly approaching (February 10, 2009), the Consumer Product Safety Commission engaged in a flurry of activities. We recently reported on the Commission’s decision …
