Pete Rutkowski

Marc Shapiro and Susan Matthees will be presenting the FDA audio briefing:    Will the FDA Approve Your Drug’s Proprietary Name? 2:00 PM – 2:45 PM ET

Ricardo Carvajal will be conducting the ABA Audioconference: Hot Topics in Food Law II 1:00 pm to 2:30 pm EST

Bob Dormer will be speaking the IPA Conference on Generic Drug Submissions and Approval Toronto, Canada

Josephine Torrente will be speaking at the FDLI Drug Law and Regulation conference. L’Enfant Plaza Hotel Washington, DC

Hyman, Phelps & McNamara P.C. has posted an updated version of its outline entitled “Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing”. This 89-page outline, authored by Alan Kirschenbaum and Jeff Wasserstein, provides a comprehensive overview of how the federal health care …

Jeff Gibbs with be speaking at the ALHA Legal Issues Affecting Academic Medical Centers and Other Teaching Institutions conference. Ritz-Carlton Hotel Washington, DC

Ricardo Carvajal will be speaking at the FDLI conference:     What you Need to Know Now about Emerging Dietary Supplements Issues & Trends L’Enfant Plaza Hotel Washington, DC

Dara Katcher Levy speaking at the Food, Drug and Cosmetic Law Section Meeting of the New York State Bar Association. Her topic will be    FDA Regulation of Rx Promotion on the Internet: A Tangled Web Marriott Marquis 1535 Broadway New York City

In light of recent public health scares over imported products, FDA is stepping up its enforcement actions through the creation of import alerts and increased scrutiny over individual shipments of FDA-regulated products. This article examines FDA’s recent activities and emerging issues.

This article, published in FDLI Update, provides an analysis of changes in the Federal Food, Drug, and Cosmetic Act (“FDCA”) brought about by the FDA Amendments Act of 2007 (“FDAAA”) that significantly affect the food industry. Title X of the FDAAA requires FDA and industry …

IVD companies face many challenges as they seek to commercialize new tests in the United States, such as issues relating to intellectual property, reimbursement, competition, manufacturing, and pricing. There is also another major hurdle: FDA. Sometimes manufacturers need to make multiple efforts to clear this …

Katie Bond speaking on “Recent Developments in Dietary Supplement Regulation Enforcement & Litigation” at the American Bar Association Section of Antitrust Law, Health Care and Pharmaceuticals Committee and Consumer Protection Committee.

Jeff Gibbs will be a speaker at both the “Implementing the Next-Generation of Antibodies: Capturing the Competitive Edge” and “Protein Diagnostic Development” meetings at the CHI 8th Annual PEP Talk. San Diego, CA

Kurt Karst will be conducting the ThompsonInteractive Audio Conference on New Drug Exclusivity Provisions: How They’ll Impact Your Product Lifecycle Management 1:00 PM – 2:30 PM ET

John Gilbert is on the planning committee for FDLI’s Regulation of Controlled Substances conference. L’Enfant Plaza Hotel Washington, DC

Brian Donato will be speaking at the ACI conference on Advertising and Promotions for the Pharmaceutical Industry. The Carlton Hotel New York, NY

Jeff Shapiro will be moderating the panel on TV, Radio, Print and “New Media”: Identifying Legal and Business Parameters for DTC Marketing of Medical Devices at the 8th National Forum on Reducing Legal Risks in the Sale and Marketing of Medical Devices The Allerton Hotel Chicago, IL

In vitro diagnostic (IVD) devices are comprehensively regulated by the FDA. The FDA, however, does not regulate just the physical materials and software comprising an IVD. From a regulatory perspective, a key component of the IVD is an intangible attribute -the product’s intended use. It …

New York Marriott East Side Hotel New York, NY

Dave Clissold will be presenting at the FDLI Introduction to Medical Device Law and Regulation conference. L’Enfant Plaza Hotel Washington, DC

Ricardo Carvajal speaking on Product Labeling and the Process for Assigning Ingredient Names at the INCI Nomenclature Workshop for the Personal Care Products Council Marriot Airport Hotel Newark, NJ

CBI’s Pharmaceutical Congress on Paragraph IV Disputes Navigating Regulations and Enforcement Trends to Increase Preparedness and Optimize Paragraph IV Strategies Philadelphia, PA

Section 912 of the FDA Amendments Act of 2007 added section 301(ll) to the Federal Food, Drug, and Cosmetic Act (FDC Act), which prohibits the addition to food of an approved drug, a licensed biological product, or a drug or biological product for which substantial …

Ricardo Carvajal will be presenting at the IFT Webinar: What is Natural? 12:00 – 1:30 p.m., CST

The question of when it is appropriate to use the term “natural” in food labeling and advertising is of intense interest to the food industry. This webcast for IFT members featured panelists from government and industry. The panelists explored FDA and USDA policies, …

Diane McColl will be conducting the IFT Webinar Section 912 – Potential Threat to Food Innovation. 12:00 – 1:30 p.m., CST

Bob Dormer will be speaking on cGMPs: Drugs and Biologics (current Good Manufacturing Practices) at the ACI FDA Boot Camp Sheraton Boston Hotel Boston, MA

Ricardo Carvajal will be speaking on Dietary Supplements GMPs: Are we ready? Legal Update at the Food, Drug, & Cosmetic Division of the American Society for Quality 19th West Coast Conference Anaheim, CA

“Personalized medicine” has been the subject of rhetorical extremes. On the one hand, there have been claims that personalized medicine is on the verge of revolutionizing healthcare, making it possible to tailor individual therapies to meet the specific needs of each patient. On the other …

Jeff Gibbs will be on Regulatory / Reimbursement Trends panel for the Goldman Sachs Inaugural Diagnostics Conference. Goldman Sachs Conference Center 32 Old Slip, 2nd Floor New York, NY

Jeff Gibbs and Susan Matthees recently published an article in MD&DI (Medical Device & Diagnostic Industry). The article provides an overview of the ruling against two AbTox executives in a case that could have significant implications for the medical device industry. Additional information available here.

Doug Farquhar will be speaking on “Complying with Corporate Integrity Agreements” at the 20th Annual FDLI Advertising & Promotion Conference for the Pharmaceutical, Medical Device, Biologics and Veterinary Medicine Industries Washington, DC

FDA has begun implementing its final rule on GMP’s for dietary supplements. Delivered at the American Society for Quality’s 19th West Coast Conference, this presentation explored the final rule’s principal requirements, and addressed compliance strategies with respect to handling of consumer complaints, FDA inspections, …

Labeling errors that involve a food allergen can lead to a Class I recall. Delivered at the American Society for Quality’s 19th West Coast Conference, this presentation explored allergen labeling requirements, the use of advisory labeling, and the interplay between dietary supplement GMP requirements …

Some companies and their executives believe that when the government asks for a certification, the executives should simply make the government happy and sign the document. A recent criminal prosecution demonstrates that a false certification can get both the company and the executive signing that …

Companies focusing on IVDs are regularly confronted with the need to make critical strategic decisions regarding how they commercialize their test. The novelty of the technology and its intended use are just some of the factors that govern what kind of application a firm can …

On June 10, 2008, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) announced the release of a newly revised version of the “Code on Interactions with Healthcare Professionals,” which is a voluntary code focusing on the industrys interactions with healthcare professionals as they relate to …

Errors in determining cosmetic ingredient nomenclature can bring unwanted scrutiny from regulators and from competitors. In a reprise of a webinar delivered to members of the Personal Care Products Council in July, this presentation delivered at the Council’s Science Week delved into ingredient labeling …

Product Labeling & Process for Assigning Ingredient Names 12:30p.m. to 2:00p.m. EDT

Bob Dormer will be speaking at the FDA and Generic Drugs Pharma Conference July 1, 2008 Hyatt Regency Bethesda Bethesda, MD

Historically, pharmaceutical and diagnostic companies in the U.S. have inhabited parallel regulatory universes. Although both sets of firms are overseen by the FDA and are subject to some identical provisions, they have been regulated independently. For the pharma industry, regulatory requirements that apply to in …

FDA’s nutrition labeling requirements are extensive and detailed, yet they afford some flexibility. Delivered at the IFT 2008 Short Course on Food Labeling and Implications for Foods Marketed in the U.S., this presentation gave an overview of those requirements, with examples of the many …

FDA’s nutrition labeling requirements are extensive and detailed, yet they afford some flexibility. Delivered at the IFT 2008 Short Course on Food Labeling and Implications for Foods Marketed in the U.S., this presentation gave an overview of those requirements, with examples of the many …

Diane McColl will be speaking June 30th on “Section 912: Potential Threat to Food Innovation”. IFT Annual Meeting: The Best of Food Thinking 2008 New Orleans Morial Convention Center New Orleans, LA

This question has been the subject of much litigation since the early 1990s. The U.S. Supreme Court has issued a string of decisions in this area, with one case pending. But the preemption waters are likely to remain roiled for some time to …

Ricardo Carvajal will be co-teaching the Food Labeling Short Course on June 27-28, and is the organizer for the symposium and roundtable “What is Natural?” on June 29 for the IFT Annual Meeting and Expo. New Orleans Morial Convention Center New Orleans, LA

Jeff Gibbs will be speaking at Food and Drug Law Institute conference on Personalized Medicine – Promises & Challenges. AAAS Auditorium 1200 New York Avenue NW, 2nd Floor Washington, D.C. 20005

Dave Clissold will be the moderator for the FDLI Webinar: Title VIII – Clinical Trial Databases: A Status Report on Implementation Webinar 1:00 – 2:30 p.m. ET

The Food and Drug Administration (FDA) has been given far-reaching responsibilities by Congress. FDA regulates a vast array of products, including foods, drugs, devices, animal drugs, biologicals, and radiationemitting products. The value of FDA-regulated products is estimated at around $1.5 trillion annually. The sheer scope …

Jeff Gibbs will be speaking on June 2nd at the IACP’s Annual Meeting & Compounders on Capitol Hill JW Marriott Pennsylvania Avenue Washington, D.C.