• where experts go to learn about FDA
    • FDA Releases Draft Guidance on Acidified FoodSeptember 30th, 2010

      By Ricardo Carvajal – FDA announced the availability of a draft guidance on acidified food intended to help processors determine whether their products are subject to the current good manufacturing practice ("CGMP") requirements in 21 CFR part 114 and the “Specific Requirements and Conditions for Exemption …

    • OIG Enforcement Initiative Regarding AMP and ASP ReportingSeptember 29th, 2010

      By Michelle L. Butler – Yesterday, the Office of the Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) issued a Special Advisory Bulletin regarding a new enforcement initiative to promote increased compliance by manufacturers with regard to reporting of average manufacturer prices …

    • FTC Complaint Charges POM Wonderful LLC’s Advertising Not Supported by Competent and Reliable EvidenceSeptember 29th, 2010

      By Riëtte van Laack – On September 27, 2010, less than two week after POM Wonderful LLC (“POM”) filed a complaint against the Federal Trade Commission (“FTC”) (see our previous post here), the Agency filed a Complaint against POM, its sister corporation Roll International Corp. and …

    • HPM Attorneys to Present at FDLI’s Enforcement and Litigation ConferenceSeptember 29th, 2010

      Hyman, Phelps & McNamara, P.C.’s Douglas Farquhar and Ricardo Carvajal will be presenting at FDLI’s upcoming two-day conference on FDA enforcement and litigation.  Mr. Farquhar will moderate a panel on elements of proof in an injunction case, and will present on misdemeanors, debarment, and exclusion.    …

    • California’s Green Chemistry Regulations; A Lot of R&R (Requirements and Responsibilities) for Regulated IndustrySeptember 28th, 2010

      By Randy Pollack*, Wes Siegner & Brian J. Donato – In September 2008, California Governor Arnold Schwarzenegger signed landmark green chemistry legislation authorizing the Department of Toxic Substance Control (“DTSC”) to: (1) identify and prioritize chemicals of concern, evaluate alternatives as well as to specify regulatory …

    • Reform of The De Novo Classification Process Needs To Be A Top PrioritySeptember 27th, 2010

      By Jeffrey K. Shapiro – The de novo classification procedure was added to the FD&C Act in 1997 to create a middle pathway between the 510(k) process and full blown premarket application ("PMA") approval.  It is intended for devices that utilize novel technologies that are not …

    • Flare-Up Over Generic Herpes Drug Could be Short-LivedSeptember 27th, 2010

      By Kurt R. Karst –    Just two days after Novartis Pharmaceuticals Corporation (“Novartis”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s September 14th approval of Watson Laboratories, Inc.’s ANDA No. 78-278 for a generic version of the herpes …

    • Novartis Sues FDA Over Generic FAMVIR; Alleges that FDA Failed to Require a Split CertificationSeptember 23rd, 2010

      By Kurt R. Karst –    On September 22, 2010, Novartis Pharmaceuticals Corporation (“Novartis”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s September 14th approval of Watson Laboratories, Inc.’s ANDA No. 78-278 for a generic version of the herpes …

    • HRSA Initiates Rulemaking to Implement Health Reform Changes to the 340B Drug Pricing ProgramSeptember 22nd, 2010

      By Jennifer B. Davis – On September 20, 2010, the Health Resources and Services Administration (“HRSA”) issued two Advanced Notices of Proposed Rulemaking and Requests for Comment (here and here) announcing its preliminary plans, and requesting stakeholder input, on how best to implement new authorities over …

    • POM Sues FTC Charging Radical Shift on Claim Substantiation Not So WonderfulSeptember 22nd, 2010

      By Riëtte van Laack & Wes Siegner – In recent consent decrees against Nestle, discussed here, and Iovate, discussed here, the Federal Trade Commission (“FTC”) appeared to be tightening its substantiation standard, prohibiting future claims for defendants’ food and dietary supplements unless they are supported by …

    • A High Wire Balancing Act: FDA and CMS to Consider Parallel Review of Medical ProductsSeptember 21st, 2010

      By Jeffrey N. Wasserstein & David B. Clissold – In a move that signals the future of medical product development, the Food and Drug Administration ("FDA") and the Centers for Medicare and Medicaid  Services ("CMS") announced that they are considering establishing a parallel review process for …

    • Senators Vigorously Object to the Inclusion of Patent Settlement Provisions in FY 2011 Appropriations BillSeptember 21st, 2010

      By Kurt R. Karst –    Last Friday, a group of Republican Senators (Sens. Jeff Sessions (R-AL), Tom Coburn, (R-OK), John Cornyn (R-TX), and John Thune (R-SD)) sent a letter to Senate Republican leaders expressing their “vigorous objection” to the inclusion of the “Preserve Access to …

    • HP&M Presents the Evolution of FDA and the Park DoctrineSeptember 21st, 2010

      Join Hyman, Phelps & McNamara, P.C. attorneys on October 8, 12:00 p.m. – 1:30 p.m. for a free webinar on a very important, timely topic.  You can register for the free webinar here.  (Please register by September 29th.) In criminal prosecutions of corporate executives, ignorance of …

    • U.S. News & World Report Ranks HP&M as Top Tier FDA Law FirmSeptember 20th, 2010

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce that the inaugural “Best Law Firms” survey by U.S. News & World Report has ranked HP&M as a “Tier 1” law firm in the area of FDA Law.  Only six firms made it to the top …

    • FDA Set to Announce Public Hearing on BPCI Act ImplementationSeptember 20th, 2010

      By Kurt R. Karst –    FDA will soon announce in the Federal Register a two-day public hearing (November 2 and 3, 2010) to obtain input on specific issues and challenges associated with the implementation of the Biologics Price Competition and Innovation Act of 2009 …