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Doubletree Suites by Hilton Times Square 1568 Broadway New York, NY 10036 Now in its 24th iteration, FDA Boot Camp is the premier event that will provide you with the…
FEBRUARY 3-4, 2015 | SONESTA HOTEL | PHILADELPHIA, PA CBI’s Expanded Access Programs is a tailored, two-day meeting for those considering or currently working on the design and execution of…
Objective and Area of Discussion: The 24th Adler Symposium will focus on three major themes: The microbiome; glucose, insulin, and brain metabolism; and neuroinflammation. Recent data indicate that the microbiome…
The Carlton Hotel, New York, NY The FDA is currently working on a draft guidance for a new regulatory framework for the cosmetics industry. However, much to the dismay of…
Renaissance Downtown Hotel 999 9th St NW Washington, DC 20001 Program Description Whether you are a regulator, litigator, compliance specialist or consultant, it is critical to stay current on the…
Fairmont Scottsdale Princess 7575 East Princess Drive Scottsdale, Arizona 85255 (480) 585-4848 The Specialty Pharma Cost Management & Medication Adherence conference will feature tools health plans can implement to successfully…
Renaissance Dupont Circle Hotel 1143 New Hampshire Avenue, NW Washington, DC 20037 • John Fleder will be presenting “FTC and the Regulation of Medical Devices, 11:15 am – Noon on…
RDD Asia 2014 was a two day meeting that seeked to link Asian regulators, industrial and academic scientists, clinicians and business professionals with their international counterparts with the goal of…
Genzyme Center Corporate Headquarters 500 Kendall Street Cambridge, MA 02142 Join us for the 1st ever MassBio Patient Advocacy Summit. We’ll bring industry leaders together with patient advocates and other…
Josephine Torrente speaking on “Formal Dispute Resolution at CDER: When, Why and How – Strategy for Discussing Formal Dispute Resolution” at the DIA Annual Meeting. San Diego, CA…
ABA – 2014 Section of Litigation Food & Supplements Workshop. This years one-day program will be held at Cargill, Incorporated in Wayzata, MN. They have lined up a great group…
Ricardo Carvajal is speaking on “Regulation of US Health Claims” at the FDLI Webinar – EU vs. US Health Claim Regulation. 10:00am to 12:00pm ET…
Anne Walsh is a co-presentor for the session on “Examining Hot Button Areas For FDA & Related Government Enforcement” at the FDA Intensive conference on Advanced Regulatory, Legal and Compliance…
Jeff Shapiro is speaking on “Review of Recent Compliance” at the Advmed Advertising and Promotion of Medical Devices Workshop. Sheraton Crystal City Arlington, VA…
John Fleder is speaking on “The Federal Trade Commission and the Regulation of Medical Devices” at the Advertising and Promotion fo Medical Devices Workshop. Sheraton Crystal City Arlington, VA…
Kurt Karst speaking on “Legal & Regulatory Challenges to Biosimilar Approval and Substitution in the United States” at the World Congress of Biosimilars and Biobetters. Hainan International Convention and Exhibition…
Anne Walsh and Allyson Mullen are conducting a webinar on “Device Off-Label Promotion Squarely On FDA’s Radar Screen” 1:30 p.m. – 3:00 p.m. EDT…
Ricardo Carvajal is panelist for the session “Update on Dietary Supplements & FSMA” at The Food, Drug, & Cosmetic Division of the American Society for Quality 24th West Coast Conference….
Jeff Gibbs is speaking on “Comprehensive Status Update on IVD Regulations Navigating the FDA IVD Approvals Process” at IVD Technology’s IVD Business Strategy Conference. The Hilton San Diego Bayfront…
Dave Clissold is a panelist for the session on “FDA Regulation of Tobacco: A Review of 2013, What to Expect in 2014” at the FDLI FDA Regulation of Tobacco Products…
Paul Hyman is part of the panel discussion on “Exploring Continuing Legal and Regulatory Conundrums Associated with the Monograph System and the OTC Drug Review Process: A call and Case…
Brian Donato is a panelist for the session on “Enforcement Developments in China and U.S.: Critical Updates and Key Issues” at the FDLI International Conference – China-US Updates in Food…
Allyson Mullen speaking on “Post Market Issues” at FDLI’s conference on Introduction to Medical Device Law and Regulation: The Legal Framework for Medical Device Regulation. Crowne Plaza Cabana Hotel Palo…
Frank Sasinowski is speaking on “The Rising Power of the Patient’s Voice in Drug Development and FDA Actions on New Therapies” and on An Analysis of FDA’s Subpart H Approvals…
American Bar Association (“ABA”) named our FDA Law blog to the 2013 (and 7th Annual) ABA Journal Blawg 100 – the top 100 best blogs for a legal audience. This…
Ricardo Carvajal is speaking on “Preventive Controls and Foreign Supplier Verification: Focus on Dietary Ingredients and Supplements” at the Food, Drug, & Cosmetic Division of American Society for Quality 23rd…
Jeff Shapiro is conducting the MDR Guidance webinar, sponsored by FX Conferences. 2:00 to 3:00 pm…
Kurt Karst will be a co-speaker on “New Exclusivity Challenges for Brand Names and Generics” at the ACI Paragraph IV Disputes Master Symposium. Millennium Knickerbocker Hotel Chicago, IL…
Ricardo Carvajal presenting as part of a symposium titled “Food Safety in the Global Supply Chain: Facts vs. Myths” at the AACC International Annual Meeting. Albuquerque Convention Center Albuquerque New…
Jeff Shapiro is speaking on “Advertising, Promotion and Labeling” at the RAPS The Regulatory Convergence conference. John B. Hynes Veterans Memorial Convention Center 900 Boylston Street Boston, MA…
Jeff Gibbs has received the FDA Medical Device Attorney of the Year award from award from LMG Life Sciences.
Kurt Karst is speaking on “180-Day Exclusivity and Forfeiture: A Dissection of Key Filing Benchmarks and Timing Considerations for Counsel on Both Sides” at the International Congress on Paragraph IV…
Anne Walsh is speaking on “Adverse Event Monitoring, Pharmacovigilance and Risk Management” at the FDA Boot Camp. Omni Parker House Boston, MA…
Ricardo Carvajal is speaking on “FSMA and Foreign Supplier Verification: Impact on Industry” at the Institute for Food Safety and Health Annual Meeting. Burr Ridge Conference Center Burr Ridge, IL…
Kurt Karst is the conference Co-Chair for the ACI Legal and Regulatory Summit on Generic Drugs. He will be providing Opening Remarks on 7/17 and is the moderator for the…
Doug Farquhar is moderating the “cGMP Compliance: How Will FDA Evaluate Your Company?” session at the Understanding cGMPs – What Attorneys Need to Know FDLI conference. Alston + Bird LLP…
Roger Thies is speaking on “Clinical Trial Disclosure: Keeping Ahead of the Wave”, a webinar presented by Hyman, Phelps & McNamara, P.C. in conjunction with Dechert, LLP. 12:45 PM to…
Dave Clissold is speaking on “Clinical Trial Disclosure: Keeping Ahead of the Wave”, a webinar presented by Hyman, Phelps & McNamara, P.C. in conjunction with Dechert, LLP. 12:45 PM to…
Ricardo Carvajal participating in a panel discussion entitled Global Regulation of Nanomedicines: Can We Harmonize the Guidelines? The New York Academy of Sciences Nanomedicines: Addressing the Scientific and Regulatory Gap…
Jeff Gibbs is moderating the FDLI Webinar: The Nuts-and-Bolts of the Drug Quality and Security Act. 12:00 to 1:30pm ET…
Kurt Karst will be moderating a panel on Industry Round Table: Weighing in on the Emerging State Controversy on Biosimilars Substitution and Naming InterContinental New York Barclay 111 East 48th…
Jeff Shapiro speaking on “Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(k)s” and on “Advertising and Labeling” at the RAPS Medical Device Submission and Compliance conference….
Wes Siegner will be speaking at: FDA Los Angeles District Office and Orange County Regulatory Affairs Discussion Group Present The 17th Annual FDA-OCRA Educational Conference Integrated Regulatory Pathways in a…
Kurt Karst is a panel member for the FDLI Webinar Doing Business with India: Latest Developments in Pharmaceutical Regulation. 12 to 2 pm…
Frank Sasinowski appeared on a panel before the House Energy and Commerces Subcommittee on Health to present testimony at the first hearing on the 21st Century Cures Initiative. The Subcommittee…
Bob Dormer is a co-presenter for the session on “International Regulatory Updates: Asia & Japan” at the Florida Medical Manufacturers Consortium (FMMC) Annual Florida Medical Device Symposium. St. Petersburg, FL…
Jamie Wolszon is speaking on “Premarket Approval Application (PMA)” at the FDLI Introduction to Medical Device Law and Regulation: The Legal Framework for Medical Device Regulation Conference. K&L Gates 1601…