Expertise in all things FDA
This book published by Thomson Reuters, delves into how health care products, including drugs, medical devices, biologics, and dietary supplements, are regulated across 21 major jurisdictions throughout the world. Jeff Gibbs is one of the general editors. Jeff Gibbs, Jennifer D. Newberger, and Alexander J. …
This RAPS article discusses the recent trends and developments in personalized medicine, including FDA’s current thinking and new challenges facing industry. Despite the promising potential of personalized medicine, the field is still in its infancy and there is much uncertainty. The article surveys key issues …
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Drug Development and FDA Actions on New Therapies” and on An Analysis of FDA’s Subpart H Approvals According to FDA’s Draft Guidance on Expedited Programs for Serious Conditions: FDA Flexibility Again!”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
Hyman, Phelps & McNamara, P.C. is pleased to announce that Kermit L. Jones, J.D., M.D. has joined the firm as an Associate. Prior to joining the firm, Dr. Jones served as a 2012-2013 White House Fellow assigned to the Secretary of Health and Human Services, …
Over the years, FDA’s regulation of in vitro diagnostics (lVDs) has raised many policy issues. Some are short-lived and quickly resolved, such as the creation of the Analyte Specific Reagent (ASR) regulation, and the subsequent guidance which curtailed the distribution of ASRs. Other policy issues …
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
Over the past year, the US Food and Drug Administration (FDA) has steadily acted against medical device manufacturers for off-label promotion. FDA’s enforcement against medical device manufacturers has typically taken the form of Warning Letters. Between 1 May 2012, and 30 April 2013, …
On February 22, 2013, FDA issued a draft guidance intended to help medical device manufacturers distinguish product enhancements from recalls. Unfortunately, the draft guidance created more questions than it answered. This article discusses, among other things, a new interpretation of the Part 806 …
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 …
Over the years, FDA’s regulation of IVDs has raised many policy issues. Some are short-lived and quickly resolved, such as the creation of the analyte-specific reagent (ASR) regulation, and the subsequent guidance that curtailed the distribution of ASRs. Other policy issues remain open for decades. …
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 …
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
On May 4, 2013, Hyman, Phelps & McNamara, P.C. Director Jeffrey K. Shapiro presented a draft paper and slides on the 510(k) medical device substantial equivalence program during a conference on FDA in the 21st Century. The conference was held at the Harvard Law School’s …
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
On December 27, 2011, the Center for Devices and Radiological Health (CDRH) issued a draft guidance document on its appeals processes. On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) became law, and put in place processes for medical …
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 …
In a new Contemporary Legal Note published by the Washington Legal Foundation (“WLF”), Douglas Farquhar explores issues surrounding privileged material and so-called “taint teams” when government investigators seize company materials that may be used to build a criminal case. Additional information available here.