Expertise in all things FDA
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 Global Market
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 Street New York, NY 10017
Kurt Karst is a panel member for the FDLI Webinar Doing Business with India: Latest Developments in Pharmaceutical Regulation. 12 to 2 pm
Anne Walsh and Jennifer Thomas co-authored Chapter 22, “, Significant Settlements”, of FDLI’s book “Top 20 Food and Drug Cases, 2013 & Cases to Watch, 2014” The chapter provides summary of the top settlements that have occurred in 2013 affecting drugs, biologics, devices, foods and dietary …
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 sought expert testimony about the proposals put forth in the 2012 “Report to the …
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
In vitro diagnostics (IVD) companies today are facing a number of challenges related to FDA regulation of their products and tests. And many of these challenges can be summed up with just one word: uncertainty. Many regulatory challenges for IVD companies relate to issues that …
Earlier this year, FDA issued the final guidance, “
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 K Street, NW Washington, DC
Six of the firm’s attorneys have been named “Super Lawyers” in the Washington, D.C. area in the 2014 Washington DC Super Lawyers Magazine. Super Lawyers is a rating service of outstanding lawyers from more than 70 practice areas who have attained a high-degree of …
Kurt Karst is speaking on “Assessing GDUFA Implementation and Additional Regulatory Developments at FDA Which Impact Paragraph IV Litigation” at ACI’s Paragraph IV Disputes conference. The Conrad New York, NY
David Clissold is speaking on 5 Years of the Tobacco Control Act: Progress and Challenges Ronald Reagan Building & International Trade Center 1300 Pennsylvania Ave, NW Washington, DC
Anne Walsh is the moderator for the Personalized Medicine Bootcamp, Part III: Regulatory Oversight of Genetic Products and Services Webinar.
FDA and LDTs – What’s Next? The Administration is claiming power over laboratory-developed tests. However, the lab industry disagrees. Jeffrey N. Gibbs Additional information available here.
James Shehan spoke About Biosimilars Regulation: US v. EU at the American Academy of Managed Care Pharmacy, 26th Annual Expo and Summit
Download full report here
Hilton Alexandria Mark Center 5000 Seminary Road Alexandria, VA 22311 (703) 845-1010
FDANEWS Webinar – Kurt Karst is speaking a on “Cut Drug Approval Time: Is A 505(b)(2) the Right Way to Go” March 25 – 1:30 to 3 pm EST
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.
Ricardo Carvajal is speaking Latin American Food Congress 2014; Mexico City, MEXICO; [RC 3/6 Panelist: Safety Modernization Act Proposed Regulations How Will They Impact the Way the Global Food Industry Operates in the Future? The Westin Santa Fe Mexico City, Mexico, D.F. 01219
Jeff Shapiro is panelist for the session on “FDA Guidances, CDRH’s Appeals Process Guidance and the MDR Guidance” at FDLI Medical Device conference BakerHostetler Washington Square, Suite 1100 1050 Connecticut Avenue, NW Washington, DC
Anne Marie Murphy is presenting on The focus is how Patients can work with the FDA and Industry on Expanded Access, Compassionate use & Emergency IND’s 8:00-10:30am
Kurt Karst is a co-presenter for the session on “Exclusivities: New Developments, Controversies and Concerns for Small and Large Molecules and Combination Products” at the ACI conference on Pharmaceutical and Biotechnology Patent Life Cycles. New York, NY
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
Hyman, Phelps & McNamara, P.C. has updated the firm’s outline on the Application of the Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices. The outline, which was last updated in 2009, has been expanded to cover devices as …
For the fourth year in a row, Hyman, Phelps & McNamara, P.C. has been ranked as a “Tier 1” law firm in the area of FDA Law (both nationally and in Washington DC) by the folks over at U.S. News & World Report, who teamed …
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
Jeff Gibbs was honored when The Food and Drug Law Institute (“FDLI”) awarded him with the 2013 Distinguished Service and Leadership Award. The award is given each year to as many as four individuals from various areas of the food and drug law community …
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
Hyman, Phelps & McNamara, P.C. is pleased to announce that James C. Shehan has joined the firm as Of Counsel. Previously, Mr. Shehan served for 19 years as Novo Nordisk Inc.’s General Counsel and Corporate Vice President of Legal, Government and Quality. His …
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