• where experts go to learn about FDA
    • Court of Appeals Affirms District Court’s Denial of Preliminary Injunction against COOL RegulationsMarch 31st, 2014

      By Riëtte van Laack – The U.S. Court of Appeals for the District of Columbia Circuit recently declined to stop USDA/AMS implementation of the amended Country of Origin Labeling ("COOL") regulations for beef, pork, and poultry products requiring identification of the country where the animals are …

    • Evaporated Cane Juice Case Evaporates (For Now)March 30th, 2014

      By Ricardo Carvajal – A putative class action targeting certain food products that declare “evaporated cane juice” (ECJ) as an ingredient was recently stayed based on the doctrine of primary jurisdiction.  As noted by the Court, prior decisions have gone both ways on the question of …

    • Like Spring, GMA Science Forum is Just Around the CornerMarch 30th, 2014

      GMA Science Forum 2014 kicks off on April 6 in Washington, DC.  The Forum will feature numerous sessions addressing scientific and regulatory issues of interest to the packaged food industry.  A complete agenda is available here.  HPM attorneys will help present a half-day introduction to …

    • FDA Issues Proposed Rule Amending Classification and Reclassification Regulations for Medical Devices (21 C.F.R. Part 860)March 27th, 2014

      By Allyson B. Mullen – On March 25, 2014, FDA issued a proposed rule amending the regulations for classification and reclassification to conform to the changes to the Federal Food, Drug, and Cosmetic Act (the Act) made by the Food and Drug Administrative Safety and Innovation …

    • Game On! The HP&M Crossword PuzzleMarch 26th, 2014

      Earlier this week we gave a “Coming Soon” announcement about a forthcoming posting of an FDA-related crossword puzzle written by Jeffrey N. Gibbs and Etan J. Yeshua as part of a celebration of Hyman, Phelps & McNamara, P.C.’s 34th anniversary earlier this month.  Well, it’s here …

    • Limitations Imposed on Use of FDA Warning LettersMarch 25th, 2014

      By Anne K. Walsh – The Supreme Court of Arkansas recently overturned (here and here) a lower court’s $1.2 billion award to the State of Arkansas, and also reversed and remanded the decision granting over $200 million in attorney’s fees and costs to the state.  Putting …

    • Independent Innovator and Repurposing Act Would Create New Patent Term Extension for Certain Biologics PatentsMarch 25th, 2014

      By Kurt R. Karst –       Earlier this week, Senator Richard Blumenthal (D-CT) and Representatives Joaquin Castro Joaquin Castro (D-TX) and Randy Forbes (R-VA) introduced the “Independent Innovator and Repurposing Act” in their respective houses of Congress (S. 2150; H.R. 4287).  Styled as a bill “[t]o advance …

    • FDA Expands Electronic Safety Reporting for Animal FoodMarch 25th, 2014

      By Ricardo Carvajal – FDA announced that it has implemented a new electronic reporting tool for livestock animal food problems, which the agency refers to as the Livestock Food Reporting Portal.  Essentially, the portal expands the categories of reports that can be submitted through the Safety …

    • Perrigo Sues FDA Over Failure to Grant Therapeutic Equivalence Rating for Testosterone Gel 505(b)(2) NDAMarch 23rd, 2014

      By Kurt R. Karst –        In a Complaint filed last Friday in the U.S. District Court for the District of Columbia, Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company (collectively “Perrigo”) (represented by Hyman, Phelps & McNamara, P.C.) allege that FDA has shirked a duty under the …

    • Coming Soon: The HP&M Crossword PuzzleMarch 23rd, 2014

      (In our best Don LaFontaine voice) IN A WORLD where food and drug attorneys and regulatory professionals are all work and no play, there’s something coming to relieve the monotony and to spice up your work life.  That’s right, after a very, very long hiatus, our “Lighter Side …

    • The Numbers Are In! 2013 Was An Across-the-Board Record Breaker for Orphan DrugsMarch 21st, 2014

      By Kurt R. Karst –       Since we started this blogging gig seven years ago (March 6th was our anniversary) we’ve strived to cover topics of interest to FDA-regulated companies, fellow food and drug and healthcare lawyers and regulatory personnel, as well as people just generally interested …

    • FDLI’s Winckler to Step Down as President and CEO; Search UnderwayMarch 20th, 2014

      The Food and Drug Law Institute (“FDLI”) recently announced that President and Chief Executive Officer Susan C. Winckler will step down from that position effective May 23, 2014.  Ms Winckler, a pharmacist and attorney, was named to the position in November 2009.  She previously served …

    • FDA Issues Revised Final Guidance Regarding Administrative Procedures for CLIA CategorizationMarch 19th, 2014

      By Allyson B. Mullen – On March 12, 2014, FDA issues a revised version of the Guidance Document “Administrative Procedures for CLIA Categorization” (the “2014 Guidance”).  FDA, Guidance for Industry and FDA Staff, Administrative Procedures for CLIA Categorization (March 2014).  The 2014 Guidance replaces the final …

    • Snowball Effect: The Incidence of Premature Paragraph IV Certification Notice GrowsMarch 18th, 2014

      By Kurt R. Karst –       It was just a little more than three months ago that we blogged on the topic of “premature notice” in the context of a Complaint filed by Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) against Par Pharmaceutical, Inc. (“Par”) concerning Par’s notice of …

    • State Marijuana Initiatives Put U.S. in the Hot Seat with the INCBMarch 17th, 2014

      By John A. Gilbert – The 57th session of the Commission on Narcotic Drugs (“CND”) recently convened in Vienna, Austria.  A prominent issue on the first day of the general session included concern over the increased use of cannabis, especially for recreational purposes.  The International Narcotics …