By William T. Koustas – We have previously reported (here, here, here, and here) on the court struggle in the United States District Court for the District of Columbia (“the Court”) between FDA and Regenerative Sciences, Inc. (“Regenerative”). Regenerative challenges FDA’s claim that the company’s stem …
By Kurt R. Karst – A Standard Operating Procedures and Policies (“SOPP”) prepared and used by FDA’s Office of Orphan Products Development (“OOPD”) for the review of orphan drug designation requests was recently made public and provides some interesting (and helpful) insight into OOPD’s policies. Of particular …
By Ricardo Carvajal – FDA announced its first seizure of a food that was administratively detained pursuant to FDA’s expanded authority under the Food Safety Modernization Act ("FSMA"). FSMA amended the FDC Act to make it easier for FDA to exercise the administrative detention authority that …
By Kurt R. Karst – “That’s all I can stand, I can’t stands no more.” Those were the words spouted by Popeye the Sailor at the climax of each cartoon episode after having been threatened with bad behavior from an antagonist like Bluto or the Sea …
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 …
