Pete Rutkowski

Ricardo Carvajal will be speaking at NanoBiotech 2009 Troy, NY

Douglas Farquhar and James Ellison will be speaking at the FDLI Conference on Enforcement and Litigation. The Madison Hotel Washington, DC

Jeff Gibbs speaking at the Clinical Proteomic Technologies for Cancer (CPTC) 2009 Annual Meeting. Hyatt Regency Bethesda, MD

Kurt Karst will be presenting “Operating Compliantly and Legally during Pending Approval” at CBI’s 2nd Annual Forum on Early Access Programs Philadelphia, PA

Dietary supplement cGMP regulations apply to all companies that manufacture, pack, label, hold, or distribute dietary supplements but not to suppliers of dietary ingredients, non-dietary ingredients, or other components. The regulations also apply to suppliers of bulk dietary ingredients that only need to be …

John Gilbert has authored an article titled “Efforts to Combat Prescription Drug Abuse Should Not Limit Access to Compounded Pain Medicine” in the September/October 2009 issue of the International Journal of Pharmaceutical Compounding. Additional information available here.

Bob Dormer will be presenting 505(b)(2) & Related Applications: EU, US and Canada at the RAPS Annual Conference & Exhibition Pennsylvania Convention Center Philadelphia, PA

Jeff Gibbs will be presenting a Webinar for Genetic Alliance on Genetic Testing In A Changing Regulatory Landscape. 11:00am – 12:00pm ET

Ricardo Carvajal will be presenting “Spotlight on Nanotechology” at the ACI FDA Boot Camp. Omni Parker Hotel Boston, MA

Bob Dormer will be speaking at the American Conference Institute FDA Boot Camp. Omni Parker Hotel Boston, MA

Ricardo Carvajal will be conducting a webinar on Reportable Food Registry. This is part of FDLI’s webinar series on Issues and Implementation of the Food and Drug Administration Amendments Act of 2007 1:00 – 2:30 p.m. ET

Brian Donato will be presenting on “Legal Issues” at the OCRA Design Controls for Devices and Drugs meeting. Irvine Marriott 18000 Von Karman Avenue Irvine, CA

Congress carefully defined the term “custom devices” in 1976, but questions about the meaning of that term have persisted ever since. A recent court case provided an opportunity to clarify the scope of the custom device exemption, for a device that qualifies as a custom …

Dave Clissold and Ricardo Carvajal will be conducting a webinar on Family Smoking Prevention and Tobacco Control Act for Thompson Interactive. 1:00 – 2:30 pm

Brian Donato and Jeff Shapiro will be conducting the Virginia CLE webcast on Enforcement Powers and Practices of the U.S. Food and Drug Administration. 12:00 noon – 1:30 p.m.

Kurt Karst will be conducting the audio conference FDA Unapproved Drug Initiative – Determine, Prove and Ensure Compliance for Thompson Interactive 2:00 pm ET 90 minutes

John R. Fleder has written an article in the July/August 2009 edition of Update Magazine, which is published by the Food and Drug Law Institute. The article discusses a recent ruling by a federal appeals court in Chicago. That decision vacated and reversed a felony …

Josephine Torrente will be speaking at FDLI Monoclonal Antibodies (MAbs) Conference. Sheppard, Mulllin, Richter & Hampton LLP Washington, DC

Jeff Shapiro moderating the FDLI audio conference on Human Tissue Regulation. 12:30 – 2:00 p.m. ET

Jim Phelps will be presenting Overview of WHO Review Process Related to Domestic and International Scheduling: The Need for Increased Transparency at the DIA 45th Annual Meeting on June 23rd. San Diego, CA

IRB Closures: Avoiding and Managing the Unexpected in Clinical Trials 12:30 – 2:00 p.m. ET

Paul Hyman will be a participant in the “Regulatory Roundtable: Overview of Federal Agencies and Implications for the Personal Care Products Industry Under the New Administration” on June 19th. Personal Care Products Council: 2009 Legal & Regulatory Conference The Fairmont Waterfront Vancouver, British Columbia

Many marketing applications for in vitro diagnostics (IVDs) need to be supported by clinical data. This is especially likely for new analytes or new intended uses. In some instances, the only means to gather the requisite data is by conducting a prospective study. Sometimes, only …

Bob Dormer will be presenting the “Generic Drug Regulatory Update” at the FDA/OCRA 12th Annual Educational Conference Irvine Marriott 18000 Von Karman Avenue Irvine, CA

Diane McColl will be participating in the panel discussion on the Expert Report at the Institute of Food Technologists Annual Meeting & Food Expo. Anaheim, CA

Ricardo Carvajal will be participating in the IFT Annual Meeting + Food Expo Anaheim, CA He will be an instructor on food labeling on June 5-6. He will also be presenting legal perspectives on GRAS determinations and the use of “natural” claims on June 8-9.

Introduction to Biotechnology Law and Regulation: A Program Focusing on Human Biologicals and Drugs The Embassy Suites Washington, D.C. Convention Center Hotel 900 Tenth Street, NW Washington, DC 20001

Ricardo Carvajal will be speaking at the FDA Fellows conference: Introduction to Food Law and Regulation: A Program on Understanding How the Government Regulates the Food Industry FDA 10903 New Hampshire Avenue Silver Spring, MD

Published in Business Law Today (a publication of the American Bar Association’s Section of Business Law), this article provides an overview of federal regulation of “green” labeling claims such as “organic”, “natural”, and “sustainable”. The use of these valuable marketing claims is governed by …

Ricardo Carvajal will be presenting at the ACI Webinar on Nanotechnology Law, The Essential Guide to the Legal & Regulatory Aspects of Nanotechnology.

Dermatologists have at their disposal a wide range of products to recommend or prescribe to their patients, all of which are regulated in some way by the Food and Drug Administration (FDA). However, the degree to which FDA has confirmed the safety and efficacy of …

Josephine Torrente will be speaking at the Society for Clinical Trials 30th Annual Meeting Omni Hotel, CNN Center Atlanta, GA

Josephine Torrente will be speaking at the RADARS System Annual Scientific Meeting Bethesda, Maryland

Jeff Gibbs will be chairing the “Meet the CDRH Director” session at the 2009 FDLI Annual Conference. L’Enfant Plaza Hotel 480 L’Enfant Plaza, SW Washington, DC 20024

Ricardo Carvajal will be a speaker for the FDLI webinar: What is Natural? 12:30 – 2:00 p.m. ET

Bob Dormer and Brian Donato will be speaking at Florida Medical Device Symposium, an annual event presented by Florida Medical Manufacturers’ Consortium, Inc. Tampa Marriott Waterside Hotel & Marina

John Gilbert will be presenting the “Legal Update” at the State and PDMA Regulatory Conference on “The Increasing Impact of Federal and State Requirements on Sampling and Prescription Drugs”. Arlington, VA

Ricardo Carvajal will be speaking on FDAAA – Prohibition on adding “drugs” to food, and advent of the Reportable Food Registry at the IFT FLDR mid-year meeting. Kirkpatrick & Lockhart Preston Gates Ellis LLP 1601 K Street, NW, Washington, DC 20006-1600

Ricardo Carvajal will be conducting the Nanotechnology Workshop at the FDA Boot Camp presented by ACI. Millennium Broadway Hotel New York, NY

New York, NY

Diane McColl will be presenting Is Your Food Ingredient a Drug? Regulatory Update on FDA’s Implementation of Section 331(ll) of the FDC Act at the IFT Wellness 09 conference Chicago, IL

John Fleder and Kurt Karst will be conducting a webinar for FDA News. The Real Impact of Wyeth v. Levine: How to Survive in a Post-Preemption World 1:30 p.m. – 3:00 p.m. EDT

Hosted by the Clinical Device Group 12:00 p.m. – 1:30 p.m. Eastern

In Wyeth, the Court ruled that, based on the facts of that case, the Federal Food, Drug, and Cosmetic Act does not preempt state law. Although the immediate effect was to let stand the state law tort judgment against Wyeth, the effects of the …

In order to sell diagnostic devices in the U.S., in vitro diagnostic (IVD) manufacturers need to get marketing authorization from FDA. That raises an obvious question: How does a company know what data to submit and which regulatory pathway to use? One way is to ask …

Dave Clissold will be speaking at the FDLI Introduction to Medical Device Law and Regulation Conference. The Embassy Suites DC Convention Center Hotel Washington, DC

Diane McColl will be speaking at the Update for the EAS Consulting Food Labeling Compliance Review Seminar and Update EAS Consulting Group – Training Facility 1940 Duke Street, Suite 200 Alexandria, VA

Anne Marie Murphy will be presenting at the ICPHSO 16th Annual Meeting and Training Symposium Orlando, Florida

Kurt Karst will be speaking at IPA/AAPS/FIP Conference – To and thru the Skin Mumbai, India

Carrie Martin will be conducting the audioconference    REMS A Year Later – Five Case Studies for FDA News