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Jeff Gibbs is a panelist for the “Legal Jeopardy from the Conduct of Clinical Trials” session at the DIA Annual Conference. Philadelphia, PA…
12:30 – 2:00 p.m. ET This webinar will feature HPM attorneys Doug Farquhar, John Fleder, and Anne Walsh, who bring the full perspective of experience in government enforcement, including a…
Dara Katcher Levy is a panel member for the session on “Importing FDA Regulated Goods: Satisfying New Safety Requirements and Agency Compliance Expectations” at the ACI Import Compliance & Enforcement…
Dave Clissold is speaking at the “EU and US Regulatory Issues for IP Professionals” on “Orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products”. The Rembrandt Hotel London, England…
Josephine Torrente speaking on “Innovators, Generics, and REMS: Current and Emerging Issues” at the Risk Management and Drug Safety Summit. The National Press Club 529 14th Street, NW Washington, DC…
Jeff Gibbs is a panel member for the session on “Hot Topics in Medical Device Regulation: 510(k) Process; Risk Management; Social Media” at the FDLI Medical Device Regulation and Litigation…
Bob Dormer is presenting the webinar “Best Practices in dealing with FDA Inspections” for MedMarc. 2:00 PM EDT…
Jeff Shapiro and Kurt Karst are conducting the FxTrans Promotion Webinar 11:15 am to 12:30 pm…
Kurt Karst is a moderator for the panel discussion “New Exclusivity Challenges: Brand Names Take Notice – It’s Not Just a Concern for Generics Anymore” at the ACI Paragraph IV…
Bob Dormer speaking at Florida Medical Manufacturers Consortium (MMC) Medical Device Symposium. St. Petersburg, FL…
Jeff Shapiro is speaking on “Why the 510(k) Pathway is the Right Approach for Most Medical Devices” at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard…
Hyman, Phelps & McNamara, P.C. is pleased to announce that Joseph (“Jay”) W. Cormier, J.D., Ph.D. has joined the firm as an Associate. Prior to joining the firm, Dr. Cormier…
Ricardo Carvajal is moderating and presenting in a session titled “Impact of the US Food Safety Modernization Act on International Regulatory Policies and Trade” at the Food Safety Summit Expo…
Ricardo Carvajal is moderating a breakout session titled “Dietary Supplements/Cosmetics/Food: Nanotechnology at a Crossroads” at the FDLI Annual Conference. Washington, DC…
Kurt Karst is a moderator for the “Drug Exclusivity Session” at the Food and Drug Law Institute Annual Conference. The Ronald Reagan Building and International Trade Center Washington, DC…
Jeff Gibbs is speaking on “Ten Tips for IVD Manufacturers” at the AMDM’s 40th Annual Meeting & OIVD Submissions Workshop. Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road…
Kurt Karst will be presenting “FDA Updates” at the Specialty Pharma Association 2013 Annual Conference. Orlando, FL…
Jennifer Newberger is speaking on “Registration and Listing” at the FDLI Introduction to Medical Device Law & Regulations conference. The St. Regis Hotel 932 16th Street, NW Washington, DC…
John Gilbert is speaking on “DEA and FDA Regulation of Controlled Substances: What to Expect in 2013” at the FDLI Controlled Substance conference. Georgetown Westin Washington, DC…
Kurt Karst is speaking on “Drugs and Biologics” at ACI’s FDA Boot Camp. Doubletree Suites Times Square New York, NY…
Ricardo Carvajal is speaking on “Food Import and FSMA Preventive Controls” at Food Chemical News’ The Impact of FSMA on Food Importing Conference. Washington, DC…
Anne Walsh is a panel member on the American Law Journal Television Program: “Off Label Drug Marketing and Free Speech”. CNN Philadelphia- WFMZ-TV 7:00 to 7:30 pm…
Kurt Karst is speaking on “Top Game Changing Regulatory Decisions” at the CHPA Annual Executive conference. Ritz-Carlton Golf Resort Naples, Florida…
Jeff Shapiro is speaking on: Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)s (Thursday, March 7 from 1:00 to 2:30 pm) Advertising & Labeling (Friday, March…
Alan Kirschenbaum is speaking on “Analyzing CMs/FDA Interplay in Government Payor Pricing and Reimbursement: Interpreting the Intent Behind the Inclusion of FDA Regulatory terminology in the AMP Draft Rule and…
Doug Farquhar is a co-panelist for the session on “Regulation of Pharmacy Compounding: Historical Analysis” at FDLI Pharmacy Compounding Webinar. 8:30 a.m. to 1:30 p.m EST Hyman, Phelps & McNamara…
Dave Clissold speaking on: Orphan Exclusivity . . . continued Regulatory Strategy and Appropriate Interaction with Authorities The Regulatory Frameworks for Advanced Therapy Medicinal Products at the EU and US…
12:00 – 2:00 p.m. ET Register This webinar is not just another summary of the long-awaited decision by the Second Circuit in United States v. Caronia, available here. Nor is…
Anne Walsh is speaking on “Freedom to make Truthful Promotional Speech: Rediscovering First Amendment Protection Strategies for your Marketing Defense” at the ACI conference on Advertising, Promotions and Digital Marketing…
Jeff Gibbs presenting a “Medical Device Legal Update” at the New York State Bar Association Annual Meeting of the Food, Drug and Cosmetic Law Section. Hilton 1335 Avenue of the…
Kurt Karst will be speaking on “Patent and Non-Patent Exclusivities for Drug and Biological Products in the USA – An Overview and Current Developments” at the Global IP Convention. INDIA…
Jeff Shapiro conducting audioconference on “When a 510(k) or PMA Goes Off Track – FDA’s Appeals Process”. 11:30 am to 12:30 pm EST…
Diane B. McColl has been elected to serve as the new President of the International Society of Regulatory Toxicology and Pharmacology (“ISRTP”)….
John Fleder is moderating the session “Hot Topics in Enforcement: 2012 Review, 2013 Preview” at the FDLI Enforcement, Litigation and Compliance Conference FDLI Conference. The Westin Georgetown Washington, DC…
Jeff Shapiro is conducting a webinar on “Discovering the Impact of the FDA’s Eagerly Awaited Final Risk-Benefit Guidance” 1:00 to 2:30 pm…
Ricardo Carvajal is participating in a panel on “The Impact of the Food Safety Modernization Act on the Food Industry” at the ABA Section of Litigation Food & Supplements Second…
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…
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….
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….
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 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…
Kurt Karst will be speaking at the Informa Inhalation Drug Development Conference London, UK…
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…
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…
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…
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…
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 &…
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….