Expertise in all things FDA
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 …
Ricardo Carvajal is moderating and presenting in a session titled “Impact of the US Food Safety Modernization Act on International Regulatory Policies and Trade” at the Food Safety Summit Expo and Conference. Baltimore Convention Center One West Pratt Street Baltimore, Maryland
Ricardo Carvajal is moderating a breakout session titled “Dietary Supplements/Cosmetics/Food: Nanotechnology at a Crossroads” at the FDLI Annual Conference. Washington, DC
Kurt Karst is a moderator for the “Drug Exclusivity Session” at the Food and Drug Law Institute Annual Conference. The Ronald Reagan Building and International Trade Center Washington, DC
Jeff Gibbs is speaking on “Ten Tips for IVD Manufacturers” at the AMDM’s 40th Annual Meeting & OIVD Submissions Workshop. Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road North Bethesda, MD
Kurt Karst will be presenting “FDA Updates” at the Specialty Pharma Association 2013 Annual Conference. Orlando, FL
Jennifer Newberger is speaking on “Registration and Listing” at the FDLI Introduction to Medical Device Law & Regulations conference. The St. Regis Hotel 932 16th Street, NW Washington, DC
John Gilbert is speaking on “DEA and FDA Regulation of Controlled Substances: What to Expect in 2013” at the FDLI Controlled Substance conference. Georgetown Westin Washington, DC
Bob Dormer is presenting the webinar “Best Practices in dealing with FDA Inspections” for MedMarc. 2:00 PM EDT
Kurt Karst is speaking on “Drugs and Biologics” at ACI’s FDA Boot Camp. Doubletree Suites Times Square New York, NY
Kurt Karst is speaking on “Top Game Changing Regulatory Decisions” at the CHPA Annual Executive conference. Ritz-Carlton Golf Resort Naples, Florida
Anne Walsh is a panel member on the American Law Journal Television Program: “Off Label Drug Marketing and Free Speech”. CNN Philadelphia- WFMZ-TV 7:00 to 7:30 pm
Jeff Shapiro is speaking on: Premarket Notification Background, Substantial Equivalence and Techniques for Identifying Predicates for 510(ks)s (Thursday, March 7 from 1:00 to 2:30 pm) Advertising & Labeling (Friday, March 8 from 10:30 am to 12:00 pm) at the Medical Device Submission & Compliance Strategies for the …
Alan Kirschenbaum is speaking on “Analyzing CMs/FDA Interplay in Government Payor Pricing and Reimbursement: Interpreting the Intent Behind the Inclusion of FDA Regulatory terminology in the AMP Draft Rule and understanding Its Repercussions” at the ACI Prescription Drug Pricing conference. Doubletree Suites Times Square New York, …
Doug Farquhar is a co-panelist for the session on “Regulation of Pharmacy Compounding: Historical Analysis” at FDLI Pharmacy Compounding Webinar. 8:30 a.m. to 1:30 p.m EST Hyman, Phelps & McNamara Office 700 13th Street, NW Suite 1200 Washington, DC
Dave Clissold speaking on: Orphan Exclusivity . . . continued Regulatory Strategy and Appropriate Interaction with Authorities The Regulatory Frameworks for Advanced Therapy Medicinal Products at the EU and US Regulatory Issues for IP Professionals conference. Geneva
12:00 – 2:00 p.m. ET Register This webinar is not just another summary of the long-awaited decision by the Second Circuit in United States v. Caronia, available here. Nor is it merely high-level positing about the future of off-label promotion prosecutions, such as here and here. …
Jeff Gibbs presenting a “Medical Device Legal Update” at the New York State Bar Association Annual Meeting of the Food, Drug and Cosmetic Law Section. Hilton 1335 Avenue of the Americas New York, NY
Anne Walsh is speaking on “Freedom to make Truthful Promotional Speech: Rediscovering First Amendment Protection Strategies for your Marketing Defense” at the ACI conference on Advertising, Promotions and Digital Marketing for the Life Sciences Industry. Union League Philadelphia, PA
Kurt Karst will be speaking on “Patent and Non-Patent Exclusivities for Drug and Biological Products in the USA – An Overview and Current Developments” at the Global IP Convention. INDIA
Jeff Shapiro conducting audioconference on “When a 510(k) or PMA Goes Off Track – FDA’s Appeals Process”. 11:30 am to 12:30 pm EST
Diane B. McColl has been elected to serve as the new President of the International Society of Regulatory Toxicology and Pharmacology (“ISRTP”).
John Fleder is moderating the session “Hot Topics in Enforcement: 2012 Review, 2013 Preview” at the FDLI Enforcement, Litigation and Compliance Conference FDLI Conference. The Westin Georgetown Washington, DC
Ricardo Carvajal is speaking on “Food Import and FSMA Preventive Controls” at Food Chemical News’ The Impact of FSMA on Food Importing Conference. Washington, DC
Kurt Karst is speaking at the Workshop: “Hatch-Waxman and BPCIA 101 – A Primer on IP Basics and Regulatory Fundamentals” at ACI’s Paragraph IV Disputes conference. San Francisco, CA
Josephine Torrente speaking on “Innovators, Generics, and REMS: Current and Emerging Issues” at the Risk Management and Drug Safety Summit. The National Press Club 529 14th Street, NW Washington, DC
Dave Clissold is speaking at the “EU and US Regulatory Issues for IP Professionals” on “Orphan drug exclusivity, FDA regulatory strategies, and advanced therapy products”. The Rembrandt Hotel London, England
Bob Dormer is a panelist for the session on “Pre-Conference Intensive Deep-Dive into the Orphan Drug Act: Demystifying the Designation Process and Discovering the Accompanying Incentives” at the ACI Orphan Drugs and Rare Diseases Conference Hyatt Regency Boston, MA
Frank Sasinowski will take part in Catholic Medical Mission Board (CMMB) meetings at the Vatican, including with the Pope, addressing the medical and pharmaceutical needs of people around the world. During the past 10 years, CMMB has delivered over $2 billion of medicines in …
Katie Bond is presenting “Doing Business in High-Risk Categories” at the Council for Responsible Nutrition/VIRGO Health & Nutrition.
Bob Dormer is speaking on “Hatch-Waxman Basics: Abbreviated Applications, Patents and Exclusivities” at the FDLI Introduction to Drug Law and Regulation conference. Hilton East Brunswick Hotel New Brunswick, NJ
Frank Sasinowki is lecturing at Cornell University’s Sloan Program in Health Administration on “Drug Development and Health Care”. Ithaca, NY
Jeff Shapiro is speaking on “Review of Recent Compliance Issues” at the AdvaMed/MTLI Advertising and Promotion Workshop. Washington Marriott Metro Center Hotel Washington, DC
Frank Sasinowki, board member of the National Organization for Rare Disorders (“NORD”), is giving the keynote address for the Campaign Urging Research for Eosinophilic Disease’s (“CURED’s”) first research symposium on eosinophilic gastrointestinal disorders (“EGID”).
Jeff Gibbs is a Tutorial Instructor for “Personalized Medicine” session Panelist for “Regulatory, Ethical and Social Policy Issues in Personalized Medicine: Discovery to Clinic” session Panelist for “Regulatory Pitfalls in Getting IVDs and Companion Diagnostics FDA Approved Communications with the FDA” session at DIAs 7th Annual Conference Discovery through …
Jeff Shapiro will be speaking on “Fundamentals of FDA Regulatory Device Law” and on “Overview of Device Regulation” at ACI’s FDA Boot Camp Devices Edition. Chicago, IL
Jeff Shapiro is speaking at the Orthopedic Surgical Manufacturer’s Association Fall Meeting on “Advertising and Promotion”. Arlington, VA
Kurt Karst will be speaking on “Making the Case for An Rx to OTC Switch: Legal and Regulatory Considerations” at ACI’s Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs. The Carlton Hotel New York, NY
Kurt Karst is a co-speaker at ACI’s Maximizing Pharmaceutical Patent Lifecycles conference for the session: “Exclusivities and Forfeitures: New Developments, Controversies, and Related Concerns”
James Ellison is speaking on “Bolstering Trial Strategy in Litigation over AMP Calculations to Mitigate Exposure” at the ACI’s National Forum on Pharmaceutical Pricing Litigation. Carlton Hotel New York, NY
Anne Walsh is a moderator for the session on “Trends and Priorities in Enforcement: Updates from HHS OIG and DOJ Officials” at the FDLI Advertising and Promotion Conference. Capitol Hilton Hotel Washington, DC
Kurt Karst is a co-presenter for the session on “Demystifying the Scope and Potential Impact of Proposed Legislation on Biosimilars to Enable You to Make Strategic Decisions Now” at the C5 EU Pharma Regulatory Law conference. Le Meridien Hotel, Brussels
Diane McColl is speaking on “Oversight/Governance: Over an Increasingly Complex Food-scape” at the USP Science and Standards Symposium: Functional Foods and Dietary Supplements-Global Opportunities and Challenges. Boston Renaissance Waterfront Boston, MA
Ricardo Carvajal is a panel member for “Compliance Challenges” and “Enforcement Hot Topics ” at the The Food, Drug & Cosmetic Division of the American Society for Quality 23rd West Coast Conference Dietary Supplement Global Strategies. Disneyland Hotel at Disneyland Resort Anaheim, California
Katie Bond presenting “Truth Stranger Than Fiction: Recent Developments in Dietary Supplement Litigation, Regulation and Truth in Advertising” at the Eighth Annual Nutrition Law Symposium.