Pete Rutkowski

Jeff Gibbs will be presenting at DIA 46th Annual Meeting. Washington, DC

Dara Katcher Levy and Carrie S. Martin will be presenting a webinar on FDA proposed rule on DTC broadcast ads. Sponsored by FDA News.

Michelle Butler will be presenting “Federal Government Contracts and Pricing: FSS, VA, DOD and More” ACI: RX Drug Pricing Boot Camp May 25 – 26, 2010 Sheraton Fisherman’s Wharf San Francisco, CA

Jeff Shapiro will be presenting “Effectively Responding to Warning Letters and Protecting Your Company’s Interests”. ACI: FDA Enforcement Summit – Fortifying Regulatory and Compliance Practices in the New Era of Aggressive Enforcement The Union League Philadelphia, PA

Jeff Gibbs has authored a chapter in FDLI’s In Vitro Diagnostics: The Complete Regulatory Guide book. His chapter focuses on IVDs that are developed and submitted to FDA for commercialization and addresses some of the key aspects of marketing IVDs, including the regulatory review processes, …

Brian Donato will be speaking at the MAGI 2010 Clinical Research Conference. Sheraton Boston Hotel Boston, MA

Bob Dormer will be speaking at the Washington Legal Foundation media briefing on “An Approval Pathway for ‘Biosimilars’: What’s Next for FDA on Health Care Law Implementation?”

Dave Clissold and Nisha Shah will be conducting a webinar on Falsified Data in Clinical Trials – How to Determine What to Report to the FDA. Sponsored by FDA News. 1:30 p.m. to 3:00 p.m. EDT

Jeff Wasserstein will be speaking on social media at the CHPA Regulatory and Scientific Conference. Hyatt Regency Bethesda One Bethesda Metro Center 7400 Wisconsin Ave. Bethesda, Maryland 20814

Paul Hyman will be presenting “Emerging Technologies and Crossover Jurisdiction (Combination Products)” at the Personal Care Products Council Legal and Regulatory Conference. LaPlaya Beach & Golf Resort Naples, Florida

Kurt Karst will be speaking at the AIPLA Spring Meeting New York Marriott Marquis New York, NY

Kurt Karst will be presenting “Legal Perspective on Approval and Legal Challenge Process for Topically Active Generic Inhalers” at the Respiratory Drug Delivery Meeting Omni Orlando Resort Orlando, Florida

Jeff Wasserstein will be speaking at the breakout session on social media. FDLI Annual Conference Hilton Washington Hotel Washington, DC

Risk Evaluation and Mitigation Strategies (REMS) Managing product risks and complying with FDAAA safety regulations The Carlton Hotel on Madison Avenue New York, NY

Jeff Wasserstein will be presenting “Using Social Media, Internet Search Ads, and Emerging Channels to Communicate with Consumers: Avoiding Mistakes and Triggers for Government Scrutiny” at the American Conference Institute conference on Advertising, eMarketing & Promotions for the Pharmaceutical Industry. Philadelphia, PA

Bob Dormer will be speaking at the Florida Medical Device Symposium Sheraton Inn & Suites Westshore Tampa Airport Tampa, Florida

Jeff Shapiro will be speaking at the RAPS DC/Baltimore Chapter Current Developments on the 510(k) Process RAPS Training Center Rockville, MD 5:30 to 8 pm

Jeff Gibbs will presenting New Product Approval Requirements at the FDA. Diagnostic Marketing Association’s Annual Conference Philadelphia, PA

Ricardo Carvajal speaking on “The FDA’s Direction and Management’s Responsibility in Food Safety” at 114th International Association of Operative Millers Conference & Expo.

Jeff Gibbs will be presenting “Regulation and Dessemination of Off-Label Information” at ACI’s FDA Boot Camp. Millennium Broadway Hotel New York, New York

Kurt Karst will be conducting an audio conference on “Navigating the Orphan Drug Designation Process, and the Benefits of Obtaining Designation” For Thompson Interactive 1:00 pm ET Duration: 90 minutes

Josephine Torrente will be speaking at Howard L. Reed Conference Massachusetts College of Pharmacy and Health Sciences Gillette Stadium One Patriot Place Foxborough, MA 02035

Kurt Karst presenting at the CBI West Coast Forum on Early Access Programs (EAP). His topic is “Understand and Navigate the Legal Landscape for Early Access Programs” San Francisco, CA

Dave Clissold will be speaking at the FDLI Introduction to Medical Device Law and Regulation conference. The Madison Hotel Washington, DC

Dave Clissold presenting GLG Webinar on “New Faces, New Outcomes? Inside the FDA Drug Approval Process.”

Ricardo Carvajal speaking on “FDA Under the Obama Administration” at the North American Millers’ Association 2010 Division Meeting.

The FDA actively regulates medical devices intended for diagnostic use. Diagnostic kits intended for diagnostic use face the full panoply of FDA regulation. In sharp contrast, research use only (RUO) products are essentially unregulated. In fact, although RUO products are often discussed as though they …

The Washington Legal Foundation has published a Legal Opinion Letter authored by Jeffrey N. Wasserstein and Nisha P. Shah. Additional information available here.

Kurt Karst will be speaking at the Biotech & Pharmaceutical Patenting conference. Hilton Munich Park Munich, Germany

Park Hyatt Washington Hotel Washington, DC

Josephine Torrente will be presenting a “Review of REMS Draft Guidance” at the FDLI Emerging Realities in REMS Planning and Execution conference. Park Hyatt Washington Hotel Washington, DC

Dave Clissold will be presenting a webinar on “Opioid Class REMS: What’s It All About?”

Ricardo Carvajal speaking on “Food Safety: Unintended Components/Contaminants of Food” at the FDLI Introduction to Food Law and Regulation Annual Conference.

Many new diagnostic tests, including protein-based ones, enter the market as a laboratory developed test. This article briefly describes regulation of these laboratory developed tests. Additional information available here.

Hyman, Phelps & McNamara, P.C. is very pleased to announce that J.P. Ellison and Kurt R. Karst have been named Directors of the firm. Mr. Ellison works primarily on civil and criminal litigation matters, including pre litigation enforcement matters likely to lead to litigation. …

The article in a recent issue of the Food and Drug Law Institute Update magazine focuses on the Tobacco Act’s impact on retailers.

As FDA becomes more comfortable with the authority provided to it by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), the frequency of Risk Evaluation and Mitigation Strategies (“REMS”) being applied to an entire class of drugs is increasing. The most notable example …

This FDLI article summarizes the new Family Smoking Prevention and Tobacco Control Act’s major provisions and highlights some of the legal issues that implementation of the law is likely to raise. Early indications suggest that FDA will move expeditiously to implement the FSPTCA. FDA has …

San Francisco Airport Marriott Burlingame, CA

Josephine Torrente will be presenting FDAAA Title IX: Effectively Dealing with Post-Marketing Safety Requirements and other Pharmacovigilance Concerns at the ACI conference: Managing Legal Risks and Avoiding Conflicts of Interest in Medical Affairs The Union League Philadelphia, PA

Paul Hyman will be speaking at the International Regulatory Affairs Meeting. Maceio, Brazil

Ricardo Carvajal conducting webinar on Product Labeling and Process for the Personal Care Products Council. 12:30 – 2 pm EST

Kurt Karst will be presenting on “Understanding the Role of EMEA and FDA During Patient Compassionate Use and Expanded Access” at the CBI Inaugural Forum on Pre-Approval Expanded Access Programmes for the Bio/Pharmaceutical Industry. London, United Kingdom

Jeff Gibbs will be speaking at the FDLI Introduction to Medical Device Law and Regulation conference. L’Enfant Plaza Hotel Washington, DC

Bob Dormer will be participating in a panel at the University of Maryland School of Law Emerging Issues in Food and Drug Law: A National Conference for Lawyers, Policy-Makers, and Corporate Leaders

John Gilbert will be speaking at the BuzzeoPDMA’s 7th Annual Controlled Substances Conference Crystal Gateway Marriott Arlington, Virginia

Diane McColl chairing the session on “Main aspects of the substantive EU and US Food laws” at the US Food Law Conference. She is also presenting “Comments and overview of major differences in US law” at the conference. European Food Law Association US Food Law Conference Brussels, BELGIUM

Ricardo Carvajal speaking on “FDA’s Regulation of Nanotechnology: Current Controversies and Potential Impacts on Nanomedicine” at American Society for Nanomedicine Inaugural Conference Bolger Center Potomac, Maryland

Kurt Karst will be presenting “Differences of Opinion on NCEs – What are the Scope and Limits?” at CBI’s 2nd Annual Pharmaceutical Congress on Paragraph IV Disputes Philadelphia, PA

Josephine Torrente will be presenting on Opioid REMS at the National Association of State Controlled Substances Authorities Annual Conference. Doubletree Hotel 1646 Front Street San Diego, California