Expertise in all things FDA
A recent article in Food and Drug Law Institute’s “Update” magazine provides an overview of ways to obtain advance information from FDA on regulatory issues concerning medical device clearance. The article provides a helpful overview of the options available for approaching FDA as well …
A recent article in Food and Drug Law Institute’s “Update” magazine discusses recent FDA actions against companies marketing unapproved drugs. According to the article, the FDA began an enforcement initiative with respect to such drug products in June 2006 to “ensure that all drugs marketed …
Licensing Executives Society 2008 Annual Conference Sheraton Chicago Hotel and Towers Chicago, IL
Paul Hyman will be presenting at the Personal Care Products Council Legal and Regulatory Conference. The Ritz-Carlton-A Four Seasons Hotel 160 Pearson Street Chicago, Illinois
Paul Hyman will be speaking at the Nutrition and Health Forum presented by the Drug, Chemical and Associated Technologies Association. Palm Springs, CA
This article explains FDA’s approach to the use of labeling claims that address the use of recombinant bovine somatotropin (rbST) in dairy cattle (e.g., “rbST-free”), and explores the controversy over attempts to regulate such claims under state law.
In September 2006, FDA issued a draft document, “Guidance for Industry and FDA Staff-Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.” Even though FDA issued the final guidance document one year later, its release has not ended the controversy over how ASRs should be …
This FDLI Insighter article examines the potential of § 912 not only to reduce the historic flexibility by which an article may be deemed a food or a drug, but more importantly to deter innovation in the research and development of new food ingredients. Additional information …
Ricardo Carvajal will be speaking at the NanoBioNexus conference in San Diego, CA. Clearing the US and EU Regulatory Path to Product Approval – “What Similarities and Differences Exist and How Can Companies Manage the Hurdles?” Morrison & Foerster 12531 High Bluff Drive, Suite 100 San Diego, …
Delivered at the NanoBioNexus Conference in San Diego, California, this presentation explored the similarities and differences between FDA’s regulatory approach to biotechnology and its approach to nanotechnology. It also discussed the adequacy of FDA’s existing statutory authorities and the emerging interest in regulation of nanotechnology …
Doug Farquhar will be speaking at the 2008 RAPS Horizons Conference & Exhibition The Fairmont San Francisco, CA
Bob Domer will be presenting at the 51st Annual FDLI & FDA Conference Washington, D.C.
Jeff Gibbs will be speaking on “A Look At IVD Regulation” at the Pharma MedDevice Conference Pennsylvania Convention Center Philadelphia, PA
Josephine M. Torrente will be presenting: The New Drug Approval Process: New Drug Research and Development at the FDLI conference on Introduction to Food Law and Regulation L’Enfant Plaza Hotel 480 L’Enfant Plaza, SW Washington, D.C.
Doug Farquhar will be moderating the break-out session on Unapproved Drugs; Drug Importation; Human Growth Hormone Cases at the 6th Annual FDLI Conference on Enforcement and Litigation L’Enfant Plaza Hotel 480 L’Enfant Plaza, SW Washington, D.C.
On Nov. 2, 2007, the Food and Drug Administration (FDA) published an Advance Notice of Proposed Rulemaking (ANPR) to revise nutrition labeling requirements for foods and dietary supplements. FDA requested public comments on which nutrients should be listed in Nutrition Facts and Supplement Facts labels, what …
John Fleder and John Gilbert to testify before the United States Sentencing Commission on proposed changes to the Sentencing Guidelines for FDC Act and PDMA offenses.
This morning seminar will highlight the key current regulatory issues that can help device companies achieve success. The conference will integrate the new developments that directly affect device companies: the new FDA Amendment Act, approvals of devices, post-market controls and safety reports, FDA …
FDA’s Nanotechnology Taskforce Report, issued in July 2007, identified numerous data gaps that the agency needs to fill, and recommended the issuance of guidance to clarify FDA’s regulatory approach to products derived through nanotechnology. This panel of senior FDA officials provided an update on …
Bob Dormer will be speaking at the New York State Bar Association Annual Meeting Marriott Marquis 1535 Broadway New York City, NY
The use of banked specimens by diagnostic and pharmaceutical companies is increasing. As described in a recent article by Anne Marie Murphy and Jeffrey Gibbs describing recent federal litigation, the ability of companies to use these materials can hinge on the informed consent. Additional information …
Brian Donato is one of the faculty for the National Trial Advocacy College, held at University of Virginia’s School of Law in Charlottesville.
The willingness to participate in a clinical investigation may not be affected by learning of the investigator’s financial stake, concludes a new study conducted by Gregory A. Guagnano, Ph.D., Associate Professor of Sociology and Anthropology at George Mason University and Jeffrey N. Gibbs of Hyman, …
Kurt Karst and Dara Katcher Levy will be conducting a teleconference on: FDA Amendments Act- New DTC User Fees and Potential Penalties 1:00 PM – 2:30 PM ET
Bob Dormer will be speaking at the FDLI Fundamentals of Food and Drug Law and Regulation Workshop. The Embassy Suites Washington, D.C. Convention Center Hotel Washington, D.C.
This presentation provided a detailed overview of FDA’s regulation of foods (including dietary supplements) and cosmetics as part of FDLI’s Fundamentals of Food and Drug Law and Regulation Workshop: Understanding How and Why FDA Regulates the Industries. The topics covered included food safety and …
Brian Donato will be speaking on “Agency Enforcement Powers” for the USC regulatory science course on medical products and the law.
Dave Clissold will be a speaker at the FDLI conference: FDA Implementation of the New Law The Food and Drug Administration Amendments Act of 2007 L’Enfant Plaza Hotel 480 L’Enfant Plaza, SW Washington, DC
ACI: Structuring, Negotiating and Managing Win-Win Pharma and Biotech Collaborative Agreements conference. The Westin New York at Times Square New York, NY Bob Dormer presenting: Making an Early Assessment of the Impact of Generics and Regulatory Matters on the Collaboration Protecting against authorized generics earlier in the agreement Anticipating what …
Dave Clissold speaking at FDLI conference
Kurt Karst will be a featured speaker for the Thompson Interactive audio conference on FDA “Revitalization” Legislation- Essential Changes You Must Know. 1:00 PM – 2:30 PM ET
Hyman, Phelps & McNamara, P.C. issued a detailed summary and analysis of the FDA Amendments Act (“FDAAA”), which President Bush signed into law on September 27, 2007. FDAAA amends both the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. In addition …
ASQ: 18th FDC West Coast Conference New Dietary Supplement CGMP Final Rule Disney Paradise Pier Hotel Anaheim, CA Wes Siegner will be presenting.
CTFA Webinar: California Alert – Safe Cosmetics Act Potential Ingredient List Reviewed 12:30PM to 2:00PM EST Brian J. Donato will be conducting the Webinar. Click
Josephine Torrente presenting: Understanding the FDA Process for Expediting Drug Development at the 5th Annual Symposium of the Association of Research Professionals – Baltimore/Washington Chapter
Jeff Gibbs will be the session leader for the IVD / ASR session at the RAPS 2007 Annual Conference & Exhibition. Hynes Convention Center 900 Boylston Street Boston, MA 02115
The sellers of OxyContin recently agreed to settle government allegations of improper marketing, by entering into one of the largest monetary settlements ever entered into against a pharmaceutical company and its executives. Although the case dealt with controlled substances, it has broad implications for any …
Stoel Rives LLP and the Association of Corporate Counsel Mountain West Chapter third annual Nutritional Law Symposium Thanksgiving Point Golf Club Lehi, Utah Wes Siegner will be moderating the panel discussion: “AER Implementation: What Do I Do Now?”
Jeff Gibbs will be participating in the R&D Roundtable for the Genetic Alliance: Eyes on the Prize – Truth Telling about Genetic Testing Renaissance M Street Washington, DC
Jeff Gibbs will be facilitating the CDRH/Medical Device Breakout Session for the FDLI’s Conference on Advertising and Promotion for the Pharmaceutical, Veterinary Medicine, Biologics, and Medical Device Industries. Bethesda North Marriott Hotel & Conference Center 5701 Marinelli Road North Bethesda, MD 20852
On July 17, 2007, the Centers for Medicare & Medicaid Services (“CMS”) published a final rule with comment period to implement the Medicaid Drug Rebate Program. With certain notable exceptions, which are discussed in the referenced memorandum, the final rule is largely consistent with the …
Diane McColl will be speaking on “Health-Related Claims in the U.S.” at the IFT Annual Meeting and Food Expo McCormick Place Chicago, IL
Crisis Management Program
The Department of Health and Human Services (“DHHS”) is convening a four day stakeholders workshop in Washington, D.C. beginning on July 31, 2007 to enable representatives from government, industry, and academia to discuss the government’s evolving plans to develop and procure medical countermeasures to respond …
FDA has released a new draft guidance for In Vitro Diagnostic Multivariate Index Assays (“IVDMIAs”). The first version, which was released on September 7, 2006, attracted many critical comments. The new draft seeks to address some (but not all) of those concerns. Creating …
Bob Dormer presenting Making an Early Assessment of the Impact of Generics and Regulatory Matters on the Collaboration at the ACI Conference Structuring, Negotiating and Managing Win-Win Pharma and Biotech Collaborative Agreements Allocating Risk, Responsibilities & Rewards in In-Licensing, Co-Development & Co-Promotion Deals InterContinental Mark Hopkins San Francisco, CA
Brian Donato will be speaking on Adhering to Domestic and International Guidelines, Improving Product Safety and Controlling Liability by Instituting Risk Management Strategies at the CBI Medical Device and Diagnostics Risk Management Summit. Washington, DC
12 to 1:30 pm
John Gilbert will be speaking at the 69th Annual Meeting of The College on Problems of Drug Dependence Quebec City, Canada
Josephine Torrente will be presenting The New Drug Approval Process: NDA Submission and Review at the FDLI Introduction to Drug Law & Regulation conference. The Washington Court Hotel 525 New Jersey Avenue, NW Washington, D.C. 20001