Events

Frank Sasinowski will be a panelist on BioCentury TV This Week, Profiles in Innovation, The Orphan Drug Act  One Law, Hundreds of Treatments. Broadcast 8:30 to 9 am, WUSA Channel 9, or available at 9 am on

At the Food and Drug Law Institutes (“FDLIs”) 2014 Medical Device Conference – Key Legal and Regulatory Developments, which will take place in Washington, D.C. on February 27, 2014, top FDA officials will discuss their most significant recent activities and forecast upcoming medical device activities. …

Anne Walsh is a co-presenter for the “FDA Intensive Webinar Series: Life Sciences Enforcement Year in Review: Examining Hot Button Areas for FDA & Related Government Enforcement”. 1:00 to 2:00 pm EST

Renaissance Marriott Dupont Circle, Washington, DC Feb. 10-11, Introduction to Food Law and Regulation Ricardo Carvajal presenting – “Food Safety: Unintended Components- Contaminants” Feb. 10: Pulse of the Industry: What’s Trending in 2014 Feb. 11: Global Developments: What’s your GPS? Feb. 12: Food Advertising, Labeling, and Nutrition: A …

As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple federal agencies, the courts, industry participants, and public advocacy groups are accelerating their …

FDA, IP, and FTC Developments in the Run-up to the First U.S. Biosimilar Approval As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple …

Riette van Laack is a moderator for the session on “The Food Safety Modernization Act’s Impact on CDC/FDA Operations” at the FDLI conference – CDC & FDA: Collaboration & Challenges -FSMA, Food Outbreaks, Pharmacy Compounding & Emerging Health Issues. Emory University Atlanta, GA

Doug Farquhar is co-Presenting the session on “International Inspections: Preparing for Inspection of Overseas Manufacturing Facilities by FDA and Comparable Foreign Regulatory Authorities” at ACI’s Legal, Quality, Regulatory, and Compliance Forum on Current Good Manufacturing Practices. The Washington Plaza Hotel Washington DC

John Gilbert is speaking on “Setting the Stage: Overview of DEA and FDA Regulation of Pharmaceutical Controlled Substances” at ACI’s Legal, Regulatory & Compliance Forum on Controlled Substances. The Washington Plaza Hotel Washington DC

Ricardo Carvajal and Anne Walsh are Panelists for the Litigation Roundtable: “Understanding criminal prosecution of food and supplement companies (and their corporate officers) under the Food Drug and Cosmetic Act: Best practices to avoid becoming the next Jensen Farms” 12:00 pm to 1:00 pm Eastern

John Fleder is a panel moderator for the session on “Responding to FDA Enforcement Actions – Advanced Applications” at the FDLI Enforcement Litigation and Compliance Conference. The Westin Georgetown Washington, DC

Jeff Gibbs is moderating the FDLI Webinar: The Nuts-and-Bolts of the Drug Quality and Security Act. 12:00 to 1:30pm ET

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 is the third time we have made the list. The ABA Journal is asking readers …

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 Thursday, November 21, 2013 | 8:00 AM – 5:00 PM

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 Strategies for Navigating the Next Level of FDA Regulations for Life Sciences Products. The Monaco Washington D.C

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 Center Haikou, China

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

Jeff Shapiro is speaking on “Review of Recent Compliance” at the Advmed Advertising and Promotion of Medical Devices Workshop. Sheraton Crystal City Arlington, VA

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. Anaheim, CA

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 Hotel 1 Park Boulevard San Diego, California

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 conference. Four Seasons Hotel 2800 Pennsylvania Ave N.W. Washington D.C.

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 for Modernization” at ACI’s Legal, Regulatory and Compliance Forum on Over the Counter Drugs. The …

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 and Drug Law. Beijing, China

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 Alto, CA

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 According to FDA’s Draft Guidance on Expedited Programs for Serious Conditions: FDA Flexibility Again!” …

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 West Coast Conference. Anaheim, CA

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

Jeff Shapiro is conducting the MDR Guidance webinar, sponsored by FX Conferences. 2:00 to 3:00 pm

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 Mexico

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 Litigation. W Hotel Union Square New York, NY

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

Anne Walsh is speaking on “Adverse Event Monitoring, Pharmacovigilance and Risk Management” at the FDA Boot Camp. Omni Parker House Boston, MA

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 session on “Insights from the Office of Generic Drugs” on 7/18. The Carlton on Madison …

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 Washington, DC

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 1:45 PM

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 1:45 PM

Jeff Gibbs is a co-presenter for the session on “Frame your Upcoming Diagnostics Development within a Firm Understanding of FDA Expectations” at the DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Sciences. Boston Convention and Exhibition Center Boston, Massachusetts

Kurt Karst is a panel member for the session on “The Next Frontier of Biosimilar Challenges: Naming and Substitution at the Pharmacy Level” at American Conference Institute’s 4th Annual conference on Biosimilars. New York, NY

Kurt Karst is speaking on “Orphan Drug Approval in the US (and Some EU Comparisons): Regulatory Mechanisms for Rare Pulmonary Disorders” at the Respiratory Drug Delivery conference. Intercontinental Hotel Berlin, Germany

Earlier this week, the National Organization for Rare Disorders (“NORD”) held its annual gala here in Washington, D.C. recognizing achievements and advances in the area of rare (orphan) diseases. Of course, this year is extra special; it’s the 30th anniversary of the enactment of …

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 Disputes conference. Crowne Plaza Times Square Manhattan New York, NY

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 Law School’s annual conference: “The Food and Drug Administration in the 21st Century.” Wasserstein Hall, Milstein …

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 served as a pharmacologist in the Animal Biotechnology Interdisciplinary Group in FDA’s Center for …