Expertise in all things FDA
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 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 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 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 will be speaking on “FDA Regulation of Generic Drugs” at the Informa Global Generic Strategy Summit. Kempinski Hotel Bristol Berlin, Germany
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
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 is speaking at the RAPS Webcast: Advertising, Promotion and Labeling – Marketing in a Regulated Environment. 11:00 am5:30 pm EST
At first glance, the draft guidance that the US Food and Drug Administration has issued on when to submit a new 510(k) pre-market notification for a change to an existing device does not appear to be too different from its 1997 predecessor. Both the …
For decades, products labeled for research use only (RUO) have been widely sold and used in the United States, playing a pivotal role in the development of new diagnostic tests. During this period, neither the definition of this class of products nor the marketing restrictions …
This FDLI Update article discusses the recent and highly publicized directed verdict for Lauren Stevens, the former in-house lawyer at GlaxoSmithKline, who was on trial for charges that she, basically, lied to the federal government in response to a subpoena demanding documents. United States District …
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 will be presenting “Introduction to the Combination Product Sector” at the Clinical and Regulatory Strategies for Combination Products Conference. Baltimore, MD
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
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 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 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 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 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 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 will be presenting at the NORD Partners in Progress celebration. Washington, DC
Molecular diagnostics are playing an increasingly important part in the practice of medicine. However, molecular diagnostics have not yet made the clinical impact that many had predicted. Multiple factors affect the uptake and utilization of molecular diagnostics, including government regulation. Current regulatory …
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 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
This FDLI Update article examines the increasing legislative efforts by states to require prescriptions for products containing methamphetamine precursors (such as pseudoephedrine and ephedrine), and to list them as Controlled Substances. It suggests that such laws would tend to encroach upon the practice of …
After more than 15 years of related cases in the larger matter of The First Amendment v. Dietary Supplement Health Claims, FDA mostly won one. And its winning card? Knowing that the courts will not, and cannot, independently assess whether the scientific evidence provided to …
Personalized medicine has provided both great hope and great hype. Even partial realization of the potential of personalized medicine could significantly change medicine by enabling the right patients to get the right medicine at the right time in the right dose. Yet while new diagnostic …
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
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 will be speaking on “Disease Subsetting” at the World Orphan Drug Conference. Hilton Embassy Row Washington, DC
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
Research use only (RUO) products are ubiquitous in the life science industry. They are widely sold, prominently displayed at major conferences and routinely used by laboratories. Yet, as common as RUOs are, their regulatory status is not well understood or defined. That is not surprising because …
HPM and Virginia Tech are pleased to announce the availability of the first two DVDs of the VERSUS series that is being sponsored by the University. They provide an overview of the processes a prescription drug must follow to be approved by the United States …
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 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 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
On January 18, 2011, the President issued a significant Order entitled a “Memorandum for the Heads of Executive Departments and Agencies.” The Memorandum directs “agencies with broad regulatory compliance and administrative enforcement responsibilities” to, within 120 days, “develop plans to make public information concerning …
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 Session of the DIA “Marketing Pharmaceuticals 2011: Workshop for Regulatory Professionals and Promotional Review Teams” Washington Marriott Wardman Park Washington, DC
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 will be speaking on “Generic Drug Preemption” at the Generic Pharmaceutical Association annual meeting. Hilton Orlando Bonnet Creek Orlando, Florida
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 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 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
It is an oft-cited feature of the food and drug enforcement landscape that the Federal Food, Drug and Cosmetic Act (FDCA) does not authorize a private cause of action. Increasingly, however, we see suits brought by private citizens under the Federal False Claims Act(FCA) to …
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 on “Unintended Components/Contaminants of Food” at the FDLI Food Week Conference. Washington, DC
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 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
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 …