Expertise in all things FDA
Ever wonder what happens to the thousands of medical device reports that are filed every month with FDA? Are they being put to good use? In October 2009, the HHS Office of Inspector General(OIG) issued a report titled, “Adverse Event Reporting for Medical Devices. This report …
Food and Drug Law Institute Monograph, Vol. 2., No. 3 Additional information available here.
It is obviously unlawful to discriminate because of race, religion and numerous other criteria. However, one factor generally thought not to be in the “prohibited factors” category is the location of a place of business. Should one business be held to a high degree of scrutiny …
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 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 will be conducting a Pharmalot webinar on “Navigating The FDA Accelerated Approval Process”. 1:00 PM ET Duration: 1 Hour
For over 50 years, U.S. food manufacturers and consumers have benefited from a provision of law that enables manufacturers to market a food ingredient without prior government approval – provided that the use of the ingredient is “generally recognized as safe” (GRAS). The right of …
Jeff Shapiro will be leading the RAPS webinar and simulcast on “Updates on the FDA 510(k) Clearance Process”
Ricardo Carvajal will be one of the speakers for the Personal Care Products Council Webinar: Product Labeling, Assignment Processes and Global Harmonization of INCI Names. 12:30PM to 2:00PM ET
Hyman, Phelps & McNamara, P.C. is very pleased to announce that Ricardo Carvajal has been named Director of the firm, and that Dara Katcher Levy has been named Of Counsel. Mr. Carvajal’s practice focuses on providing FDA and FTC regulatory counseling and litigation support …
Susan Matthees will be speaking on “Registration and Listing for Medical Devices” at the FDLI Introduction to Medical Device Law and Regulation conference. Westin South Coast Plaza Hotel Costa Mesa, CA
John Gilbert will speaking on “State and Federal Legal Update on Controlled Substances” at the 8th Annual Controlled Substances Industry, Pharmacy and Listed Chemicals Conference. Crystal Gateway Marriott Arlington, VA
Dara Katcher Levy will be speaking on “Analyzing the Current Pharma Communication Landscape” at the Pharmaceutical Compliance: Off-Label Drug Promotion Conference. Philadelphia, PA
Although FDA appears reluctant to take an aggressive stance with respect to substantiation of health-related claims for foods, FTC has forged ahead with a number of investigations of allegedly false or misleading advertising that have resulted in restrictive settlements – and the plaintiffs’ bar has …
Dave Clissold will be presenting “Clinical Data Falsification” at the Fifth Annual FDA Inspections Summit. Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road Bethesda, MD 20852
United Therapeutics Corporation (“UTC”), a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions, unveiled a plaque honoring Frank Sasinowski for his contributions to UTC’s development of its REMODULIN (trepostinil) …
Wes Siegner will be speaking on Foods and Dietary Supplements Structure Function Claims and Scientific Substantiation and Enforcement and Compliance: Regulatory Compliance for Food, Dietary Supplement and Medical Food Companies at the RAPS 2010 Conference San Jose McEnery Convention Center San Jose, CA
Jeff Gibbs will speaking on Gene Patents & Diagnostic Tests at the AIPLA Joint Biotechnology Committee/Special Committee on FDA Law Program for the Annual Fall AIPLA Meeting. Marriott Wardman Park Hotel 2660 Woodley Road, NW Washington, DC
Anne Marie Murphy is presenting “Understanding and Navigating Through the Legal Landscape of Early Access Programs” at CBI’s 3rd Annual Congress on Early Access Programs (EAPs). Philadelphia, PA
Kurt Karst will be presenting “FDA Forfeiture Provisions and Review of Strategic Developments” at the CBI Life Sciences Congress on Paragraph IV Disputes. Philadelphia , PA
Doug Farquhar is on the planning committee for FDLI’s Enforcement and Litigation Conference. The Westin Washington, DC
Ricardo Carvajal a breakout session on Food and Dietary Supplements at the FDLI Enforcement and Litigation Conference. The Westin Washington, DC
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, …
In criminal prosecutions of corporate executives, ignorance of the law and the facts is often no defense. FDA’s application of the Park Doctrine has taken different forms in the decades since its inception. In the 1960’s through 1980’s, FDA frequently prosecuted company officials without any …
Dave Clissold will be presenting a Webinar on “Opioid Class REMS: What’s Next?” for the Drug Information Association. 11 am to 12:30 pm
Recent developments in the European Union’s regulation on health claims used in food labeling could have the effect of suppressing publication of scientific research on the health benefits of food substances. Given that scientific research and collaboration is an international phenomenon, the negative effect …
In a January 2010 report on off-label promotion and Medicare fraud, television reporter Dan Rather asked Lewis Morris, the Chief Counsel of the Department of Health and Human Service’s Office of Inspector General (OIG): “The executives of these big pharmaceutical companies are never putting on …
Kurt Karst will be presenting “Nature of the Approval Process” at ACI’s FDA Boot Camp. Seaport Hotel Boston, MA
Paul Hyman will be presenting “Claim Substantiation” the Food, Drug, & Cosmetic Division of the American Society for Quality 21st West Coast Conference. Anaheim, CA
Jeff Gibbs will be presenting at the European Pharmaceutical Regulatory Law conference. London, England
Hyman, Phelps & McNamara, P.C. 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 …
Kurt Karst will be speaking on “FDA Update” at the Specialty Pharma Association fall conference. San Diego Marriott Hotel & Marina San Diego, CA
Kurt Karst will be participating in the panel discussion “As the Drug Patent Landscape Evolves, Strategic Challenges and Opportunities Develop” at the Rodman & Renshaw Global Investment Conference – 12th Annual Healthcare Conference. New York Palace Hotel New York, NY
The U.S. diagnostic market has long been divided into two major regulatory branches. In vitro diagnostic (IVD) kits that are sold by manufacturers to laboratories are regulated by the FDA. Tests developed by a laboratory and offered as a diagnostic service by that laboratory are …
Jeff Gibbs will be speaking on “FDA Regulation of Protein-Based Diagnostic Tests” at the Cambridge Healthtech Institute’s Accelerating Development & Advanceing Personalized Therapy Conference. Hyatt Regency Crystal City Arlington, VA
Jeff Wasserstein has written a chapter in this book. The Regulation of Social Media: Whither FDA? This chapter provides a foundational understanding of FDA’s regulation of social media and Web 2.0 and offers a practical approach to marketing in this environment. The first section briefly introduces …
In the fifteen years since the founding of IVD Technology, the IVD industry-and its regulation by FDAhave both changed. The diagnostic capabilities of IVDs have improved dramatically during that period. Some of the advances, such as high-speed, lower-cost genomic sequencing, seemed like the stuff of …
Kurt Karst will be presenting “New Trends and Challenges in PTE Litigation: Key Cases to Watch” at the ACI Life Sciences Lawyer’s Guide to Patent Term Adjustment and Patent Term Extensions conference. Downtown Conference Center New York, NY
Companies involved in advertising and promotion of foods, dietary supplements, cosmetics, over-the-counter (OTC) drugs, and devices understand that the United States Food and Drug Administration (FDA) is active these days in enforcing the Federal Food, Drug, and Cosmetic Act (FDCA). However, companies must also be …
Jeff Gibbs will be moderating the FDLI Webinar on FDA’s (Emerging) Oversight of Laboratory – Developed Tests. 12:30 to 2:00 p.m. ET
IVD manufacturers are accustomed to risk. Taking risks is part of their business. Companies develop plans to identify and mitigate risks, from product development to finished product manufacturing. While risks cannot be eliminated, generally they can be recognized and managed. One category of risks-regulatory risks – …
Diane McColl will be presenting “Overview of regulation of food ingredients and dietary supplement ingredients in the United States” at the IFT 2010 Annual Meeting and Food Expo. Chicago, Illinois
Ricardo Carvajal will be presenting “Labeling Requirements and Implications for Foods Marketed in the U.S.” and “Food regulation: Evolutionary changes in revolutionary times” at the IFT 2010 Annual Meeting and Food Expo. Chicago, Illinois
Diane McColl has been elected to the U.S. Pharmacopeial Convention’s (“USP’s”) Expert Committee for the Food Chemicals Codex (Monographs – Food Ingredients) for the 2010-2015 cycle. The committee develops new monographs and revises existing monographs and their associated reference materials for food ingredients, as …
Frank Sasinowski has been elected by the the U.S. Pharmacopeial Convention (“USP”) as an At-Large Trustee of the USP Board of Trustees for the 2010-2015 cycle. The Board of Trustees will guide the activities of the USP for the next five years and makes …
Kurt Karst will be presenting “Update on Regulatory Protections Available to Extend Patent Lifecycles: Comparing and Contrasting Europe and US” at the C5 UK conference on Maximising Pharmaceutical Patent Life Cycles. London, UK
Bob Dormer will be speaking on “Overcoming Challenges to Marketing, Branding and Promotion of Biosimilars” at the ACI Follow-On Biologics conference. The Helmsley Park Lane Hotel New York, NY
Bob Dormer will be speaking at FDA-OCRA Educational Conference. Irvine Marriott Irvine, CA
Brian Donato will be speaking at FDA-OCRA Educational Conference. Irvine Marriott Irvine, CA
Wes Siegner will be a guest speaker at the University of Maryland School of Law’s Federal Regulation of Probiotics Meeting. Baltimore, MD