Expertise in all things FDA
HP&M Attorneys to Present CLE Telephone Seminar on FSMA. The seminar is scheduled at at noon on October 16. In conjunction with Virginia CLE, Hyman, Phelps & McNamara, P.C. Director Ricardo Carvajal and Senior Counsel Brian Donato are presenting a 2-hour CLE telephone seminar that …
The Toll House Hotel 140 S. Santa Cruz Avenue Los Gatos, CA 95030 Thursday 8:30 a.m. to 4:30 p.m. PCT / Friday 8:30 a.m. to 12:30 p.m. PCT
ASEA Conference Center 1575 I Street, NW Washington, DC 20005 McPherson Square Metro A “Generally Recognized as Safe” (GRAS) Determination is a science-based process that employs the most comprehensive toxicological and exposure data, as analyzed critically and independently by experts qualified in their respective sub-disciplines to evaluate the safety …
Norton Rose Fulbright 98 San Jacinto Blvd #1100 Austin, Texas 78701 We hope that you can join us for the 2014 Current Issues in Pharmaceutical and Medical Device Litigation on Thursday, October 9, 2014, at Norton Rose Fulbright in Austin, Texas.
Kurt Karst will be speaking about “New Exclusivity Challenges for Brand Names and Generics: Exploring Their Implications for Paragraph IV Challenges” Inter Continental Hotel 505 North Michigan Avenue Chicago IL 60611
James Valentine is speaking at Global Engage’s: Orphan Drugs, Collaborations & Market Access Congress. His presentation will be about “Opportunities for Rare Disease Patients in Regulatory Decision-Making” Town and Country Hotel 500 Hotel Circle North SAN DIEGO, CA 92108
At the Beaver Hollow Conference Center 1083 Pit Road Java Center, New York 14082
Kurt Karst is speaking on “Hatch-Waxman and BPCIA Overview” at ACI’s FDA Boot Camp. Omni Parker House Boston Boston, MA
David Clissold will be Presenting at GTC’s 4th Annual CNS Diseases World Summit. Sheraton Fisherman’s Wharf Hotel 2500 Mason Street San Francisco, CA 94133 (415) 362-5500
HPM’s Jay W. Cormier will be a panel member at Livestock the Biotech Summit. He will be on the Biomedical Regulatory Pathway Panel. The panel will be discussing Applications of animal biotechnology to solve biomedical questions. This panel will discuss the regulatory paradigm for where …
Senate Help Committee Briefing organized by NORD on Expanded Access to Investigational Drugs
James Shehan spoke about FDA Regulation of the Promotional Products Industry at the Promotional Products Association International Product Safety Summit.
10:30AM – 3:30 PM Hyman, Phelps & McNamara, P.C 700 13th Street, NW Suite 1200 Washington, DC 20005 Ricardo Carjaval at the conference. In light of recent developments and increasing scrutiny of the GRAS process, our newest Dialogue Is the GRAS Process Broken? is both extremely …
Jeffrey K. Shapiro is presenting :RAPS Webinar – Updates on Medical Device Post-Market Reporting Regulations Tuesday July 22, 2014 1:00PM EST to 2:30PM EST Medical device reporting is one of the most common post-market surveillance activities required of all medical device manufacturers in accordance with the …
Jeffrey K. Shapiro will be speaking about Medical device reporting. Medical device reporting is one of the most common post-market surveillance activities required of all medical device manufacturers in accordance with the Medical Device Reporting (MDR) regulation (21CFR 803). The FDA requires device companies to account …
Douglas B. Farquhar From Hyman, Phelps & McNamara, P.C. will be a moderator at this conference. This conference, specifically tailored for lawyers but appropriate for all drugs and biologics stakeholders, will drill down into how FDA evaluates company compliance with good manufacturing practices, specifically detailing what …
James C. Shehan is speaking at the 2014 BIO International Convention San Diego Convention Center
Alan Kirchenbaum presented speaking at the ACI – Prescription Drug Pricing conference. To get an E-Doc of the conference you can order it through the link below.
Jeff Shapiro is participating in a workshop on “Regulatory Landscape: Look Forward” at the American Association for the Advancement of Science conference: “Exploring Legal Challenges to Fulfilling the Potential of Health in a Safe and Responsible Environment” 1200 New York Avenue, NW, Suite 550 Washington, DC
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
James Valentine is speaking at the DIA Annual Meeting on Patient Fellowship Workshop; Breakout Session Title: Developing strategies for advocating and engaging the FDA and other regulatory agencies Patient Voice in Decision Making: How are Regulators Making This Work?; Presentation Title: Patients Voice in Decision Making: …
Kurt Karst is speaking at the ACI – Hatch-Waxman Boot Camp in Chicago, IL InterContinental Chicago Magnificent Mile 505 North Michigan Avenue Chicago, IL 60611 Reservations: 800-628-2112
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 of speakers on the important topics affecting the food industry including the following: Emerging Issues: …
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
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
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
Anne Walsh is the moderator for the Personalized Medicine Bootcamp, Part III: Regulatory Oversight of Genetic Products and Services Webinar.
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
James Shehan spoke About Biosimilars Regulation: US v. EU at the American Academy of Managed Care Pharmacy, 26th Annual Expo and Summit
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
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
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
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