By Susan J. Matthees— FDA and the Department of Health and Human Services Office for Human Research Protections (OHRP) recently announced the availability of two guidance documents intended to help investigators, researchers, sponsors, and IRBs understand how data already collected may be used after a …
By Susan J. Matthees – FDA recently announced the availability of a new draft guidance document on the types of information FDA recommends be included in a complete submission for the evaluation of proprietary names for prescription drug products, biologics, and nonprescription drug products that …
By Bryon F. Powell – On November 26, 2008, the Massachusetts Department of Public Health delayed plans to propose emergency regulations that would implement the state’s recently enacted pharmaceutical and device marketing law at a December 10 meeting of the Public Health Council. A pair …
By Kurt R. Karst – Late last week while those of us in the U.S. were still digesting our turkey dinners, FDA issued a draft guidance document describing the Agency’s current thinking on the implementation of § 4(b)(1) of the Q1 Program Supplemental Funding Act …
By Kurt R. Karst - On November 25, 2008, FDA granted in full a citizen petition (petition supplements are available here and here) submitted by Osmotica Pharmaceutical Corp. earlier this year requesting that FDA determine that any company with a pending Abbreviated New Drug Application ("ANDA") …
By John A. Gilbert On December 4 and 5, FDLI will hold a conference on Regulation of Controlled Substances: Balancing Medical Need and Diversion Control. The conference will focus on issues related to drug scheduling and regulation of controlled substances and List I chemicals and provide …
By James P. Ellison In a November 10, 2008 response posted on November 24, 2008, FDA denied an April 27, 2005 Citizen Petition challenging a March 29, 2005 Interim Final Rule increasing Color Additive Certification Fees as violating the FDC Act and the Administrative Procedure …
By Cassandra A. Soltis The Federal Trade Commission (FTC) is seeking comments on proposed revisions to its Guides Concerning the Use of Endorsements and Testimonials in Advertising. The Guides, although advisory in nature, set forth the principles the FTC will follow in reviewing endorsements and testimonials …
By William T. Koustas & Kurt R. Karst – We previously reported that the Federal Trade Commission (“FTC”) is planning a Roundtable on Follow-on Biologics (“FOBs”) to be held on November 21, 2008 in Room 432 at FTC Headquarters in Washington, D.C. The Roundtable was …
By James R. Phelps & Kurt R. Karst – On November 17, 2008, Representatives John Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), Chairman of the Subcommittee on Oversight and Investigations of the U.S. House of Representatives, announced their most …
By James P. Ellison – FDA’s November 12, 2008 Federal Register Notice of its Direct Final Rule to comply with the Federal Civil Penalties Inflation Adjustment Act, 28 U.S.C. § 2461 note, is not in itself a blogworthy event, but it could be part of …
By Jeffrey N. Wasserstein – First, it was the son of the former Nigerian dictator who wanted my bank account information (I’m still waiting for the bank transfer, by the way!). Now, apparently FDA “special agents” are in on the act. In a scam originating out …
By Ricardo Carvajal & Diane B. McColl – FDA has announced a pretest of a survey instrument designed to gather information about five issues relevant to modernization of the food CGMP regulations at 21 C.F.R. Part 110. The food CGMP regulations are essentially unchanged since …
By Dara Katcher Levy & Ricardo Carvajal – On November 12, 2008, FDA issued an Import Alert on all food containing milk products from China. The Import Alert was issued because of concerns over melamine contamination of China’s milk products, including Chinese infant formula, which …
By Kurt R. Karst – On November 12, 2008, the U.S. Supreme Court issued its opinion in Winter v. Natural Resources Defense Council, Inc. The case concerns the Navy’s power to use “mid-frequency active” sonar in military training exercises. The Court, dividing 6-3 (Chief Justice …
