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Jeff Shapiro is speaking at the RAPS Webcast: Advertising, Promotion and Labeling – Marketing in a Regulated Environment. 11:00 am5:30 pm EST…
Jeff Gibbs will be speaking on “The Basics: Understanding and Working with the FDA – Jurisdiction, Functions, Organization, and Operations” at the ACI’s FDA Boot Camp Device Edition conference. Sutton…
Bob Dormer is a keynote speaker at the FMMC 2nd Annual Medical Devices Symposium in Tampa. His topic is “Recent Trends in FDA Medical Device Enforcement”…
John A. Gilbert will be the lead speaker for the Heathcare Distribution Management Association (HDMA) Webinar entitled Pseudoephedrine and Dextromethorphan Regulatory Review. This webinar will provide a regulatory review of…
Hyman, Phelps & McNamara is sponsoring and Wes Siegner will give a presentation at the Second Annual Nutritional Law Symposium in Salt Lake City, Utah….
Medical Device Regulation: Getting to the Market and Navigating the Regulatory Pitfalls, A symposium sponsored by Hyman, Phelps & McNamara, P.C. May 11, 2006 Hyatt Regency Irvine Irvine, CA…
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…
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,…
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 &…
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…
Frank Sasinowski will be presenting at the NORD Partners in Progress celebration. Washington, DC…
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”….
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…
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,…
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 will be conducting the FDA News webinar “Marketed Unapproved Drugs”. 1:30 to 3 pm EST…
Anne Marie Murphy speaking on “FDA Draft Guidance on Risk-Based Monitoring of Clinical Trials” at the Clinical Trial Oversight Summit. Omni Parker House Boston 60 School Street Boston, MA…
Paul Hyman will be presenting “Regulatory, Legal and Political Processes in the Development of Food Labeling” at the National Kidney Foundation – The Public Health Impact of Phosphorus Homeostasis in…
Jeff Shapiro is participating in the :”Interactive Session: How to Respond to 483s and Warning Letters” at the AdvaMed Medical Device Workshop on FDA Inspections, Warning Letters & CAPA. Sheraton…
Kurt Karst is speaking on “To 505(b)(2) or Not To 505(b)(2) Jumping the Legal Hurdles for Inhaled Drug Products” at the Respiratory Drug Delivery conference. JW Marriott Desert Ridge…
Bob Dormer will be moderating the session on “Best Practices in Dealing with FDA Inspections: Before, During & After” at the Florida Medical Device Symposium. Hilton St. Petersburg Carillon Park…
Jeff Shapiro is speaking as part of the FDA Center Director’s Roundtable panel at the FDLI’s 55th Annual Conference. The Ronald Reagan Building and International Trade Center 1300 Pennsylvania Avenue,…
Dave Clissold is moderating the session on “Building a Comprehensive Nicotine Regulatory Policy” at FDLI’s 55th Annual Conference. The Ronald Reagan Building and International Trade Center 1300 Pennsylvania Avenue, Washington,…
Jeff Gibbs will be speaking on “Advertising and Promoting In Vitro Diagnostics” at the Association of Medical Diagnostics Manufacturers Annual Meeting. Bethesda North Marriott Hotel & Conference Center 5701 Marinelli…
Anne Marie Murphy is speaking on “FDA Draft Guidance on the Movement toward a Risk-Based Approach” at CBI’s Risk-Based Approaches to Clinical Investigations. Philadelphia, Pennsylvania…
Kurt Karst will be conducting the Thompson Interactive Webinar on “PDUFA V: Preparations for the New Fees and Performance Goals” 2:00 pm ET/1:00 pm CT/12:00 pm MT/11:00 am PT Duration:…
12:30 to 2:00 p.m. ET Pharmaceutical and medical device applicants faced with an adverse decision from FDA (e.g., regarding data requirements, study design, or regulatory pathway) may dispute that decision…
Kurt Karst is speaking on “Hatch-Waxman and BPCIA Overview” at ACI’s FDA Boot Camp. Doubletree Suites Times Square New York, NY…
Jennifer Newberger will be speaking on “Clinical Investigations” at FDLI’s Introduction to Medical Device Law and Regulation conference. Park Hyatt Washington Washington, DC…
Jeff Shapiro will be speaking on “Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)s” and on “Advertising & Labeling” at the RAPS Medical Device Submission &…
Kurt Karst will be speaking on “Legal Considerations to Establish Biosimilarity and Therapeutic Interchangeability” at the University of Texas College of Pharmacy International Conference on Drug Development. He will also…
John Gilbert will moderate the session on “The Scheduling Process: What You Need to Know” at the FDLI Controlled Substance Regulation conference. Hogan Lovells Washington, DC…
Josephine Torrente will be speaking on “Reading the Drug Safety Tea Leaves – Top Legal and Compliance Challenges that Lie Ahead” at the Fourth Annual Risk Management and Drug Safety…
Ricardo Carvajal is a moderator for the Labeling and Advertising session at FDLI’s Food Week conference. Park Hyatt Washington 24th & M Streets Washington, DC…
Bob Dormer will be speaking on “Critical Issues Related to Regulation of Follow-on Biologics” at the University of Maryland, School of Pharmacy, Center on Drugs and Public Policy Invitational Conference….
Jeff Gibbs will be participating in the “Hands on Interactive Session: How to Respond to 483s and Warning Letter” at the AdvaMed conference on Avoiding A Warning Letter. Marriott Metro…
Jeff Shaprio is speaking on “The Evolution of Expectations Over Time” at the AdvaMed conference: Avoiding A Warning Letter. Marriott Metro Center Washington, DC…
John Fleder will be a panel member for the “Hot Topics in Criminal Litigation and Investigative Enforcement: 2011 Review, 2012 Preview” discussion at the FDLI Enforcement, Litigation and Compliance Conference….
Ricardo Carvajal is speaking on “Navigating Today’s Labeling Requirements&And What’s Coming Up” at the IFT Food Policy Impact conference. Sheraton Crystal City Washington D.C….
Jeff Gibbs is speaking on “Understanding the Potential Impact of Changes to the FDA 510(k) System” at R&D Portfolio Management for Medical Devices conference. San Diego, CA…
Ricardo Carvajal is the co-instructor for IFT food labeling short course: Labeling Requirements and Implications for Foods Marketed in the U.S. Sheraton Crystal City Washington D.C….
Josephine Torrente is speaking at the Regulatory Issues For IP Professionals conference in the sessions: – Orphan Exclusivity – Regulatory Strategy and Appropriate Interaction with Authorities – The Regulatory Frameworks…
Diane McColl will be presenting “Routes to U.S. Market for Functional Ingredients in Foods, Medical Foods, and Dietary Supplements” at the Conference of the American College of Nutrition. Malcolm Forbes…
Jeff Gibbs is speaking on “Prepare your Clinical Trials for Compliance with New FDA Regulations on LDTs and IVDs” at Biomarker Applications For Improved Clinical Trial Outcomes. Hilton Boston Back…
Kurt Karst is conducting the Thompson Webinar “Navigating the Orphan Drug Designation Process: Benefits of Obtaining Designation”. 2:00 pm ET/1:00 pm CT/12:00 pm MT/11:00 am PT Duration: 90 minutes…
Jeff Shapiro is speaking on “Recent Update of Compliance Issues” at the AdvaMed Advertising and Promotion of Medical Devices in an Age of DTC and Social Media Marketing conference. Four…
IFT/University of Massachusetts Symposium The Path Forward for Functional Foods: Exploring Scientific and Legal Solutions for Defining Efficacy Diane McColl presenting: Demonstrating Current System for Health Claim Efficacy – Examples,…