By Riëtte van Laack – The Court of Appeals for the Eleventh Circuit overturned a contempt order against Hi-Tech, Jared Wheat, Stephen Smith, and Dr. Terrill Mark Wright (“Hi-Tech”) because, according to the Court, the order was incorrectly premised on collateral estoppel. As we discussed in a …
By Karla L. Palmer - Earlier this week, the GAO released the Testimony of Marcia Crosse, Director, Health Care, before the Senate Caucus on International Narcotics Control. The statement, titled, “Controlled Substances: DEA Needs to Better Manage its Quota Process and Improve Coordination with FDA,” provides a …
By Andrew J. Hull* - On April 14, 2015, a federal judge in Iowa imposed a three-month term of imprisonment on two food executives, describing the period of imprisonment as “relatively small.” After a major Salmonella outbreak in August 2010 that left thousands of people sickened across …
By Ricardo Carvajal & JP Ellison – Last week, the federal district court judge presiding over industry’s challenge to Vermont’s law requiring GMO labeling issued a complex decision arising out of dueling motions. The State of Vermont had asked the court to dismiss the plaintiffs’ complaint, …
By Riëtte van Laack – Continuing its broad application of the consent decree in the action by the National Resource Defense Council against FDA (see our previous post here), FDA issued a proposal to amend the Tentative Final Monograph for Topical Antimicrobial Drug Products for Over-the-Counter …
By James C. Shehan – On April 28th, FDA finalized the three biosimilar guidances that it issued in 2012. Covering the topics of questions and answers regarding BPCIA implementation, scientific considerations in demonstrating biosimilarity, and quality considerations in demonstrating biosimilarity of proteins to reference products, the …
On April 27, 2015 the Drug Information Association journal, Therapeutic Innovation and Regulatory Science, published the findings of a study conducted by HP&M Attorneys Frank J. Sasinowski and James E. Valentine*, along with co-author, Erika B. Panico, RAC, head of U.S. Regulatory Affairs for Chiesi …
By Jennifer D. Newberger – As part of its 2014-2015 Strategic Priorities, the Center for Devices and Radiological Health (CDRH) committed to assuring the “appropriate balance between premarket and postmarket data collection to facilitate and expedite the development and review of medical devices.” By December 31, …
By Kurt R. Karst – There’s no rest for the weary! There certainly hasn’t been much rest for FDA’s litigation team this past week . . . . and it’s not getting any better. The week started off quiet (though clearly anxiety was in the air), …
By David B. Clissold – A bill, H.R. 2058, introduced into the House of Representatives is short in length, but potentially long on effect for many tobacco product manufacturers. The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) established February 15, 2007 as the …
By Riëtte van Laack – On Monday April 20, 2015, Senators Dianne Feinstein (D-Calif.) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act (S. 1014). The almost 100-page bill would significantly expand FDA's authority over cosmetic products sold in the United States. The bill …
In a new guidebook published by the Food and Drug Law Institute, David B. Clissold and James E. Valentine of Hyman, Phelps & McNamara, P.C. co-authored Chapter 3-1, “FDA Regulatory Scheme,” and Alexander J. Varond authored Chapter 3-7, “Orphan Drugs.” Both chapters cover essential elements of …
By Kurt R. Karst – As you enter the Courtroom 402 “dance hall” at the U.S. Court of Appeals for the Federal Circuit on Wednesday, June 3, 2015, you’ll have to decide whether to take an initial right step and join the Amgen Inc. …
By Allyson B. Mullen – On April 22, 2015, FDA released a draft guidance regarding use of clinical data generated outside of the U.S. (OUS) in medical device premarket submissions. A copy of the draft guidance can be found here. FDA states in the guidance that it …
By David C. Gibbons – On Tuesday, April 21, 2015, the U.S. Department of Health and Human Services Health Resources and Services Administration (“HRSA”) issued a Notice soliciting comments on its proposal to collect pricing data from drug manufacturers under the 340B drug discount program. This …
