By Jamie K. Wolszon & Ricardo Carvajal – FDA has published three draft guidances that instruct growers, packers, processors, transporters, retailers and others on the prevention of microbial hazards in tomatoes, melons, and leafy greens. According to FDA’s press release, Dr. Hamburg stated that the …
FDA Law Blog welcomes back to the blogosphere our friend Scott Hensley, formerly of the Wall Street Journal (where he was the founding editor and a regular contributor to the paper’s Health Blog). Scott will be blogging at the National Public Radio Health Blog and …
By Douglas B. Farquhar – In an August 6, 2009 speech at an event sponsored by the Food and Drug Law Institute, Margaret A. Hamburg, M.D., the new FDA Commissioner, promised to ratchet up enforcement by speeding up issuance of Warning Letters, reducing the amount of time that …
By Kurt R. Karst & Michelle L. Butler – Winston Laboratories, Inc. (“Winston”) recently sued FDA after the Agency denied a waiver of the Prescription Drug User Fee Act (“PDUFA”) application fee assessed with respect to the company’s human drug application (NDA No. 22-403) for …
By Kurt R. Karst – Earlier this week FDA issued several Federal Register notices setting the Fiscal Year (“FY”) 2010 user fee rates for human drugs under the Prescription Drug User Fee Act (“PDUFA”), for medical devices under the Medical Device User Fee and Modernization …
By Alan M. Kirschenbaum – As we reported on August 2, the House Energy and Commerce Committee last Friday reported out its healthcare reform bill, the America’s Affordable Health Choices Act (H.R. 3200). In order to help finance healthcare reform, the bill contains numerous provisions that …
By Kurt R. Karst – Judge Rosemary M. Collyer of the U.S. District Court for the District of Columbia ruled in a 27-page opinion issued last Friday that the 180-day exclusivity forfeiture patent information withdrawal provision at FDC Act § 505(j)(5)(D)(i)(I)(bb)(CC) is not ambiguous and …
By Kurt R. Karst – Last Friday, the House Energy and Commerce Committee favorably reported its version of “America’s Affordable Health Choices Act” (H.R. 3200) by a 31-28 vote after adopting several amendments. A copy of the bill and amendments are available here. Importantly, the …
By Carrie S. Martin – Last Wednesday, the Senate Special Committee on Aging held a hearing to discuss the conflicts of interest presented by the funding of continuing medical education (“CME”) by pharmaceutical and medical device companies. Lewis Morris, Chief Counsel to the Office of …
Yesterday, President Obama announced that he intends to nominate Anne Northrup as a Commissioner of the Consumer Product Safety Commission. Anne Northrup was a Congresswoman from Kentucky from 1997-2006. As we previously reported, earlier this month, Inez Moore Tenenbaum was sworn in as the ninth …
By Ricardo Carvajal – The U.S. House of Representatives has passed the Food Safety Enhancement Act of 2009, which would substantially strengthen FDA’s regulatory authority over foods. The bill would grant FDA mandatory recall authority, expanded access to records, stronger seizure and administrative detention authorities, …
By William T. Koustas – Today, the FTC announced that it is delaying enforcement of the controversial Red Flags Rule (“the Rule”) until November 1, 2009. The FTC press release states that it is extending the August 1, 2009 deadline, previously discussed in this blog, …
By Cassandra A. Soltis – In Pom Wonderful LLC v. Ocean Spray Cranberries, Inc., 2009 WL 2151355 (C.D. Cal. 2009), the U.S. District Court for the Central District of California determined that Pom Wonderful LLC’s (Pom’s) false advertising claim against Ocean Spray Cranberries, Inc. (Ocean …
By Kurt R. Karst – On July 28, 2009, FDA will publish a final rule amending the Agency’s regulations requiring that NDA holders submit in annual reports certain information to the Agency concerning authorized generics. The regulations, which were first proposed in September 2008 – …
By Ricardo Carvajal – On July 23, FDA held the first of three public workshops to explain the Reportable Food Registry requirements that will take effect on September 8, 2009. One thing was made clear: the agency has no plans to offer a definition of …
