By Riëtte van Laack – On October 4, 2011, the Center for Food Safety (“CFS”) announced the filing of what it touts as “a groundbreaking new legal petition” with FDA, demanding that FDA issue regulations that require the labeling of all food produced using genetic engineering. …
By Kurt R. Karst – The first U.S. Conference on Rare Diseases and Orphan Products started with a bang today with the release of a landmark report announcing its findings of flexibility in FDA’s review of potential treatments for patients with rare (“orphan”) diseases. The conference, …
By John A. Gilbert, Jr. & Karla L. Palmer – On Wednesday, October 5, 2011, the DEA published a final rule clarifying when a DEA registrant’s voluntarily surrender of its registration is effective. The final rule amends 21 C.F.R. §§ 1301.52(a) and 1301.62(a) to make it …
By Jeffrey K. Shapiro – A medical device manufacturer in most cases is legally required to obtain 510(k) clearance or premarket application (“PMA”) approval from the Food and Drug Administration’s (“FDA”) prior to commercial distribution. Premarket reviews are conducted under the auspices of the Office of …
By Kurt R. Karst – We have learned that FDA’s Office of Orphan Products Development (“OOPD”) has a new Acting Director. Debra Lewis, O.D., M.B.A., who is OOPD Deputy Director, and who has been serving as Acting Director since the Departure of Dr. Timothy Coté earlier …
By John A. Gilbert, Jr., Karla L. Palmer & Larry K. Houck – The Government Accountability Office (“GAO”) recently issued a report analyzing the Drug Enforcement Administration’s (“DEA’s”) efforts to combat the diversion of legal controlled substances and listed chemicals. As the title suggests, “DEA has …
By David B. Clissold & Ricardo Carvajal - FDA issued two draft guidance documents that set out the agency’s thinking with respect to new tobacco products and the requirement to either demonstrate substantial equivalence under FDC Act § 905(j) or secure premarket approval under § 910. The draft …
By Wes Siegner – We recently reported that on September 19th, FDA announced the issuance of a revised version of the Agency’s June 2006 final guidance document/Compliance Policy Guide (“CPG”), titled “Marketed Unapproved Drugs – Compliance Policy Guide Sec. 440.100, Marketed New Drugs Without Approved NDAs …
By Ricardo Carvajal - It almost escaped our notice – a blog posting by FDA asserting that “there is currently no evidence to suggest a public health risk from fruit juices, including apple juice” (emphasis added). The posting went up the same day as the airing …
By Cassandra A. Soltis – Last week, the Federal Trade Commission (“FTC”) announced a settlement with Reebok International Ltd. (“Reebok” or “the Company”) for charges that the Company disseminated false and misleading advertisements for its EasyTone and RunTone shoes. The FTC’s Complaint alleged, among other things, …
By Kurt R. Karst – Since we last updated our popular Generic Drug Labeling Carve-Out Citizen Petition Scorecard in February 2011, there have been several new citizen petitions submitted to FDA raising questions about FDA approval of ANDAs with labeling that omits information protected by periods …
By Jennifer D. Newberger – On September 30, 2011, FDA announced the issuance of a Draft Guidance, De Novo Classification Process (Evaluation of Automatic Class III Designation), intended to update and streamline the de novo review process. The de novo review process, formally known as Evaluation of …
By Ricardo Carvajal – FDA released an ambitious Draft Strategic Plan for 2012-2016 to guide the activities of its Foods and Veterinary Medicine ("FVM") Program (meaning the activities of CFSAN and CVM, as well as ORA’s food-related activities). The Plan articulates priorities organized around the following …
By Kurt R. Karst – Last week, Representative Michael McCaul (R-TX), along with Reps. G.K. Butterfield (D-NC), Sue Myrick (R-NC), and Chris Van Hollen (D-MD), introduced H.R. 3059, the Creating Hope Act of 2011. The bill is a companion bill to S. 606, which was introduced …
By Cassandra A. Soltis – There is yet another lawsuit to add to the growing list of class actions against companies marketing foods bearing “natural” claims. On September 21, 2011, a class action complaint was filed in California against Bear Naked, Inc. (“Bear Naked” or “the …
