Events

  • Diane McColl speaking at European Food Law Association Food Law ConferenceOctober 24th, 2011

    Diane McColl will be speaking on “The FDA Food Safety Modernization Act And What It Means For Importers” at the European Food Law Association Food Law Conference. Brussels, Belgium

  • Kurt Karst speaking at RAPS Regulatory Convergence ConferenceOctober 22nd, 2011

    Kurt Karst is speaking on “Generics in the US: A Regulatory Primer on Filing and Recent Actions” and in the Workshop on “Pay-to-Delay Agreements” at the RAPS Regulatory Convergence Conference. Indiana Convention Center Indianapolis, IN

  • Jeff Shapiro conducting Thompson webinarOctober 18th, 2011

    Jeff Shapiro will be conducting the Thompson webinar: Combination Products – Classification, Regulations, and Guidances 2:00 pm ET/1:00 pm CT/12:00 pm MT/11:00 am PT Duration: 90 minutes

  • Josephine Torrente panel moderator at NORD-DIA ConferenceOctober 13th, 2011

    Josephine Torrente is a panel moderator for “Collaborating on an Agenda for the Future – A Dialogue to Address the Challenges in Orphan Product Development” at the National Organization for Rare Disorders (NORD) US Conference on Rare Diseases and Orphan Products. Washington, DC

  • Kurt Karst speaking at Inhalation Drug Development ConferenceOctober 12th, 2011

    Kurt Karst will be speaking at the Informa Inhalation Drug Development Conference London, UK

  • Frank Sasinowski panel member at NORD-DIA ConferenceOctober 10th, 2011

    Frank Sasinowski is a panel member for “The Special Importance of Patient-Academic-Industry-Government Collaboration in Orphan Product Development” at the DIA & National Organization for Rare Disorders (NORD) US Conference on Rare Diseases and Orphan Products. Washington, DC

  • Kurt Karst speaking at ACI ConferenceOctober 5th, 2011

    Kurt Karst will be presenting “REMS Studies and Generic Entry: Exploring the Latest Regulatory Conundrum Affecting Pharmaceutical Patent Life Cycle Strategies” at ACI’s 12th Annual Maximizing Pharmaceutical Patent Life Cycles conference. New York, NY

  • Ricardo Carvajal speaking at ASQ Food, Drug, and Cosmetic Division Conference on Dietary Supplement ChallengesSeptember 30th, 2011

    Ricardo Carvajal is speaking on “Food Safety Modernization Act Implementation Update” and “New Dietary Ingredients” at the ASQ Food, Drug, and Cosmetic Division’s 22nd West Coast Conference on Dietary Supplement Challenges: cGMPs, Analytical, FSMA, NDI, and More. Paradise Pier Hotel at Disneyland Resort Anaheim, CA

  • Wes Siegner panelist at Seventh Annual Nutrition Law SymposiumSeptember 23rd, 2011

    Wes Siegner is a panelist for the “NDI Guidance: Light or Darkness at the End of the Tunnel?” section of the Seventh Annual Nutrition Law Symposium. Thanksgiving Point Golf Club Lehi, UT

  • Roger Thies speaking at Specialty Pharma Association ConferenceSeptember 22nd, 2011

    Roger Thies will be speaking on “FDA Update” at the Specialty Pharma Association Fall Conference. Marriott Marquis Hotel & Marina San Diego, CA

  • Wes Siegner speaking at Specialty Pharma Association ConferenceSeptember 21st, 2011

    Wes Siegner speaking at Specialty Pharma Association Conference on “Overview of Claims and Marketing Strategies for Medical Foods, Foods for Special Dietary Use, and Dietary Supplements”. Marriott Marquis Hotel & Marina San Diego, CA

  • Kurt Karst speaking at Global Generic Strategy SummitSeptember 20th, 2011

    Kurt Karst will be speaking on “FDA Regulation of Generic Drugs” at the Informa Global Generic Strategy Summit. Kempinski Hotel Bristol Berlin, Germany

  • Anne Walsh panelist at PACT Medtech LuncheonSeptember 15th, 2011

    Anne Walsh will be a panelist on “Qui Tam (Whistle Blowers) and Fraud Claims – Current Strategies and Developments” at the Greater Philadelphia Alliance for Capital & Technologies Medtech Luncheon. Applebrook Country Club 100 Line Road Malvern, PA 19355

  • How "Competent and Reliable" is Your Scientific Evidence?September 9th, 2011

    Katie Bond speaking on “How ‘Competent and Reliable’ is Your Scientific Evidence? Meeting the FTC’s Substantiation Standards for Health-Related Advertising” at the Colorado Bar Association Advertising Law.

  • Jeff Shapiro speaking at RAPS webcastSeptember 8th, 2011

    Jeff Shapiro is speaking at the RAPS Webcast: Advertising, Promotion and Labeling – Marketing in a Regulated Environment. 11:00 am5:30 pm EST

  • HPM Requests One-Year Comment Period for Draft NDI GuidanceJuly 26th, 2011

    On July 26, 2011, Hyman, Phelps & McNamara, P.C. filed a request for a one-year comment period to allow affected businesses adequate time to respond to a lengthy and controversial draft guidance on New Dietary Ingredient (“NDI”) notifications that FDA issued earlier this month.

  • Jeff Shapiro speaking at Clinical and Regulatory Strategies for Combination Products ConferenceJuly 11th, 2011

    Jeff Shapiro will be presenting “Introduction to the Combination Product Sector” at the Clinical and Regulatory Strategies for Combination Products Conference. Baltimore, MD

  • Kurt Karst speaking at FDLI ConferenceJune 24th, 2011

    Kurt Karst will be speaking on “180-Day Exclusivity Forfeiture” at the FDLI Conference: Brands, Generics, and Hatch-Waxman-New Challenges; Unabated Controversy. The Westin City Center Washington, DC

  • Jeff Shapiro presenting FX Conferences Audio ConferenceJune 21st, 2011

    Jef Shapiro is presenting an audio conference on the appeals processes available for medical device companies when FDA takes an adverse action during premarket review of a 510(k) or PMA. He will discuss practical tips and advice on how to resolve a dispute with …

  • Dave Clissold Named to ACTION Board of AdvisorsJune 15th, 2011

    Dave Clissold has been named to the Board of Advisors of Analgesic Clinical Trial Innovations, Opportunities, and Networks (“ACTION”). ACTION is a public-private partnership aligned with FDA’s recently launched Initiative for the Advancement of Regulatory Science. ACTION is designed to benefit the public …

  • Ricardo Carvajal speaking at Food Safety Regulatory Compliance SummitJune 15th, 2011

    Ricardo Carvajal will be speaking on “The Reportable Food Registry One Year Later: Best Practices for Reporting Events While Minimizing Exposure to Government Investigation or Private Litigation” at the ACI Food Safety Regulatory Compliance Summit. Chicago, IL

  • Ricardo Carvajal speaking at IFT Annual MeetingJune 11th, 2011

    Ricardo Carvajal will be presenting at the IFT Annual Meeting. His topics include: Nutrition Labeling Requirements for FDA Nutrition Labeling Requirements Nutrient Content, Structure/Function and Health Claims Other Claims: Production, Processing, and Marketing Create and Evaluate Your Own Food Label The Legal Aspects of Food Allergen Labeling and Control

  • Jeff Shapiro speaking at RAPS conferenceJune 7th, 2011

    Jeff Shapiro will be speaking on “Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)” and on “Advertising and Labeling” at the RAPS Medical Device Submission & Compliance Strategies for the US Market conference. RAPS Training Facility Rockville, MD

  • Josephine Torrente moderating session at FDLI conferenceMay 19th, 2011

    Josephine Torrente will be moderating a session titled “From Qualitative to Quantitative-Benefit Risk Models and Patient Perspectives” at the FDLI conference: Issues and Answers – Advancing Risk Evaluation and Mitigation Strategies and Benefit-Risk Management to the Next Level. The Westin City Center Washington, DC

  • Frank Sasinowski to present at NORD EventMay 17th, 2011

    Frank Sasinowski will be presenting at the NORD Partners in Progress celebration. Washington, DC

  • Kurt Karst speaking at ACI Paragraph IV Disputes ConferenceMay 4th, 2011

    Kurt Karst will be speaking on “Mastering Regulatory Maneuvers Essential to PIV Litigation” at the ACI Paragraph IV Disputes Conference. New York City, NY

  • Bob Dormer speaking at Florida Medical Device SymposiumMay 2nd, 2011

    Bob Dormer will be speaking on “Compliance Strategies for the Medical Device Industry” at the Florida Medical Device Symposium. He is also on the Panel Discussion entitled “Current FDA Issues”. Hilton St. Petersburg Carillon Park St. Petersburg, FL

  • Jeff Shapiro speaking at Association of Medical Diagnostics Manufacturers (AMDM) Annual MeetingApril 28th, 2011

    Jeff Shapiro speaking on “When a 510K or PMA Goes Off Track: What Are the Options for Appeal” at the Association of Medical Diagnostics Manufacturers (AMDM) Annual Meeting. Bethesda North Marriott Hotel and Conference Center Bethesda, MD

  • Former FDAer Linda S. Carter Joins Hyman, Phelps & McNamara, P.C.April 19th, 2011

    Hyman, Phelps & McNamara, P.C. is pleased to announce that Linda S. Carter has joined the Firm as a Regulatory Scientist. Linda, who will primarily assist HP&M’s drug development group, brings significant experience and expertise in shaping regulatory policies, particularly Comparative Effectiveness Research, Personalized Medicine, …

  • Kurt Karst speaking at World Orphan Drug ConferenceApril 13th, 2011

    Kurt Karst will be speaking on “Disease Subsetting” at the World Orphan Drug Conference. Hilton Embassy Row Washington, DC

  • Jeff Wasserstein speaking at FDLI conferenceApril 5th, 2011

    Jeff Wasserstein will be speaking on “Our Hearts are a-Twitter: Social Media and Therapeutic Products” at the 54th Annual FDLI Conference. Ronald Reagan Building International Trade Center 1300 Pennsylvania Avenue, NW Washington, DC

  • Jeff Shapiro speaking at Drug and Device Product Recalls SummitMarch 21st, 2011

    Jeff Shapiro will be speaking on “Communicating Effectively with the FDA and Collaborating with the Agency When Implementing a Recall” at ACI’s Drug and Device Product Recalls Summit. The Union League Philadelphia, PA

  • Kurt Karst conducting Orphan Drug Audio ConferenceMarch 15th, 2011

    Kurt Karst will be conducting the Thompson audio conference: Navigating the Orphan Drug Designation Process, & the Benefits of Obtaining Designation. 2:00pm to 3:30 pm

  • Jeff Wasserstein speaking at ACI conferenceMarch 14th, 2011

    Jeff Wasserstein will be speaking on “Fear Not Pharma: Revolutionizing Your Marketing Strategies to Adapt to Social Media Platforms” at the ACI 9th Expert Regulatory Guide to Advertising, eMarketing and Promotions for the Pharmaceutical Industry conference. The Union League Philadelphia, PA

  • Josephine Torrente to speak on Expediting Cancer TherapiesMarch 4th, 2011

    Josephine Torrente will be speaking on “Expediting Cancer Therapies” at the conference on Regulating the Drug Treatment of Cancer. Sponsored by the University of Washington Schools of Law, Medicine, Public Health & Pharmacy. Room 138 William H. Gates Hall University of Washington Law School Seattle, Washington

  • Jeff Gibbs moderating the CDRH Breakout SessionFebruary 23rd, 2011

    Jeff Gibbs moderating the CDRH Breakout Session of the DIA “Marketing Pharmaceuticals 2011: Workshop for Regulatory Professionals and Promotional Review Teams” Washington Marriott Wardman Park Washington, DC

  • Ricardo Carvajal to co-moderator ABA First Annual Workshop on Food and SupplementsFebruary 17th, 2011

    Ricardo Carvajal will be a co-moderator for a session on the impact of the Food Safety Modernization Act at the ABA’s First Annual Workshop on Food and Supplements, Section of Ligation, Food and Supplements Subcommittee of the Products Liability Committee. The Coca-Cola Company 1 Coca Cola Plaza Atlanta, …

  • Kurt Karst speaking at GPhA 2011 Annual MeetingFebruary 16th, 2011

    Kurt Karst will be speaking on “Generic Drug Preemption” at the Generic Pharmaceutical Association annual meeting. Hilton Orlando Bonnet Creek Orlando, Florida

  • Jeff Gibbs to be a panelist for American University Washington College of Law Founders EventFebruary 15th, 2011

    Jeff Gibbs will be a panelist for the American University Washington College of Law Founders’ event: Personalized Medicine: Ethics, Privacy, DNA and the Future of Medicine 10:00 AM to 3:00 PM American University Washington College of Law, Room 603 4801 Massachusetts Avenue, NW Washington, DC

  • Josephine Torrente to speak at FDLI conferenceFebruary 9th, 2011

    Josephine Torrente will be speaking on “The New Drug Approval Process: New Drug Research and Development” at the FDLI Introduction to Drug Law and Regulation conference. The Westin Washington, DC

  • Jeff Shapiro to speak at Physicians and Physician Organizations Law InstituteFebruary 9th, 2011

    Jeff Shapiro will be speaking on “Legal Issues in Physician-Owned Device Companies” at the Physicians and Physician Organizations Law Institute. The Cosmopolitan of Las Vegas Las Vegas, NV

  • Kurt Karst speaking at ACI Life Sciences ConferenceJanuary 26th, 2011

    Kurt Karst will be presenting “New Trends and Challenges in PTE Litigation: Key Cases to Watch” at ACI’s “The Life Sciences Lawyer’s Guide to Patent Term Adjustment and Patent Term Extensions” conference. Downtown Conference Center New York, NY

  • Ricardo Carvajal speaking at FDLI conferenceJanuary 24th, 2011

    Ricardo Carvajal speaking on “Unintended Components/Contaminants of Food” at the FDLI Food Week Conference. Washington, DC

  • Frank Sasinowski on BioCentury This Week TVJanuary 23rd, 2011

    BioCentury This Week TV will broadcast a program concerning the latest thinking about how to create a sustainable economic model for both orphan drug developers and payers. The program, titled “The Economics of Orphan Drugs  Why Successful Cures Bring Challenges for Patients and …

  • Jeff Gibbs on panel at Personalized Medicine World ConferenceJanuary 19th, 2011

    Jeff Gibbs will be part of the panel on “Aligning The Regulators and Industry To Accelerate Personalized Medicine Benefits” at the Personalized Medicine World Conference. Silicon Valley, CA

  • Anne Walsh Joins the Firm as Of CounselJanuary 3rd, 2011

    Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne K. Walsh has joined the firm as Of Counsel. Prior to joining the firm in January 2011, Ms. Walsh served as an Associate Chief Counsel with the U.S. Food and Drug Administrations Office …

  • Doug Farquhar and John Fleder to audio conference: Are Attorneys the FDA's New Enforcement Target?December 20th, 2010

    Doug Farquhar and John Fleder will be conducting the audio conference: Are Attorneys the FDA’s New Enforcement Target? 2:00 pm ET Duration: 60 minutes

  • Diane McColl elected Vice-President of the Council of the International Society for Regulatory Toxicology and Pharmacology (ISRTP)December 16th, 2010

    Diane McColl has been elected Vice-President of the Council of the International Society for Regulatory Toxicology and Pharmacology (“ISRTP”). ISRTP provides an open public forum for policy makers and scientists promoting sound toxicologic and pharmacologic science as a basis for regulation affecting human safety and …

  • Kurt Karst conducting Pharmalot WebinarDecember 9th, 2010

    Kurt Karst will be conducting a Pharmalot webinar on “Navigating The FDA Accelerated Approval Process”. 1:00 PM ET Duration: 1 Hour

  • Jeff Shapiro conducting RAPS WebinarDecember 2nd, 2010

    Jeff Shapiro will be leading the RAPS webinar and simulcast on “Updates on the FDA 510(k) Clearance Process”