Expertise in all things FDA
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
Jeff Gibbs, Marc Shapiro and Kirk Dobbins will be presenting at the North Carolina Medical Device Association Medical Tech Forum in Raleigh-Durham, NC. Recent Regulatory & Legislative Developements In FDA Device Regulation: What’s Changing?
Maximizing Pharmaceutical Patent Life Cycles The definitive Hatch-Waxman event for biopharmas, brand names and generics InterContinental Mark Hopkins Hotel San Francisco, CA Kirk Dobbins will be presenting: New Pre-Commercialization Concerns for Small Molecules and Biologics Kurt Karst will be presenting: Drugs and Biologics: The Nature of the Approval Process Present Controversies and …
Brian Donato presenting at CFTA Webinar on FDA Inspections of OTC Drug & Cosmetic Facilities: Your Rights & Obligations 12:30PM to 2:00PM EST Click here for more information.
Bob Dormer will be conducting FDLI/CDRH In-House Training on an Introduction to Food and Drug Law Regulation; Understanding How the Government Regulates the Drug Industry. Rockville, MD
JW Marriott San Francisco San Francisco, CA Jeff Gibbs presenting Regulation and Dissemination of Off-Label Information on May 16th. Overview of the FDA’s regulation of off-label promotion How can information on off-label or nonapproved uses of drugs and biologics be disseminated? peer review articles v. ghost-writing MSLs v. sales reps What are …
Brian Donato will be speaking on Global Approaches to Risk Management at Congress Risk Management Program. This program is sponsored by FDA, AdvaMed and Virginia Tech, Bethesda, Maryland.
Hyman, Phelps & McNamara, P.C. is very pleased to announce that Jeffrey K. Shapiro has joined the firm as a director and Carrie S. Martin has joined the firm as an associate. Prior to joining the firm, Mr. Shapiro was a partner at Hogan & …
On May 7, 2007, the United States Court of Appeals for the Fourth Circuit decided the case of Pharmacists Mutual Insurance Company v. G. David Scyster, No. 06-1334. The case relates to a lawsuit where the plaintiff asserted that it had no liability for injuries …
Josephine Torrente will be speaking at FDLI Workshop: Introduction to Biotechnology Law and Regulation Workshop Focusing on Human Biologicals and Drugs The Madison Hotel 1177 Fifteenth Street, NW Washington, D.C. 20005 (202) 862-1600
Hyman, Phelps & McNamara, P.C. is very pleased to announce that Jeffrey K. Shapiro has joined the firm as a director and Carrie S. Martin has joined the firm as an associate. Prior to joining the firm, Mr. Shapiro was a partner at Hogan & …
Christine Bump will be presenting at the Surface Mount Technology Association’s Medical Electronics Symposium Sheraton Hotel Minneapolis, MN
Washington Legal Foundation Vol. 32 No. 17 Additional information available here.
CTFA 2007 Legal & Regulatory Conference Mansion on Forsyth Park Savannah, Georgia Brian Donato presenting: Is There Such a Thing As a Functional Cosmetic?
Food Update 2007 – Food, Nutrition and Public Policy Amelia Island, GA April 21-24, 2007 Jeff Gibbs’ April 23rd presentation will be: How Viable is the Business Opportunity? Mr. Gibbs will also be participating in the panel discussions.
Jeff Gibbs will be speaking at the Association of Medical Diagnostic Manufactures 34th Annual Meeting. Marriott Bethesda North Hotel and Conference Center 5701 Marinelli Road North Bethesda, MD 20852
On April 10, 2007, CMS issued a draft of its revised Clinical Trial Policy, renamed Clinical Research Policy. The draft policy was issued after CMS’s consideration of public comments on the agency’s July 10, 2006 coverage tracking sheet announcing the reconsideration of the September 19, …
During the past several years, government enforcement authorities have focused an increasing amount of attention on the marketing activities of medical device companies. This increased scrutiny has taken the form of investigations through subpoenas and intervention in qui tam lawsuits (lawsuits initiated by a third …
On October 18, 2006, the Center for Medicare & Medicaid Services (CMS) issued a proposed rule expanding the collection and permitted uses of Part D data. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) permits, and in some cases requires, CMS …
A recent California case raised the question of whether, within the context of the attorney-client privilege, regulatory advice provided by food and drug attorneys qualifies as “legal” (protected) advice or “business” (generally not protected) advice. This California court ruling demonstrates that regulatory advice that food …
Jeff Gibbs with be speaking on “A Look At IVD Regulation” at the PharmaMedDevice conference in Philadelphia, PA.
Brian Donato and Robert Dormer will be speaking at the upcoming RAPS 2007 Horizons Conference & Exhibition. The Palace Hotel 2 New Montgomery Street San Francisco, CA
FDA Inspections – A Year in Review Presented by BuzzeoPDMA and Hyman, Phelps & McNamara, P.C. John Gilbert and Kirk Dobbins will be speaking at this conference. Crystal Gateway Marriot Arlington, VA
American Conference Institute InterContinental The Barclay New York, NY Jeff Gibbs presenting Regulation and Dissemination of Off-Label Information on May 16th. Overview of the FDA’s regulation of off-label promotion How can information on off-label or nonapproved uses of drugs and biologics be disseminated? peer review articles v. ghost-writing MSLs v. sales …
Hyman, Phelps & McNamara, P.C. (HPM) submitted a citizen petition to FDA in 1992 asserting that the agency did not have the authority to regulate assays developed by clinical reference laboratories strictly for in-house use (laboratory developed tests). FDA responded to the petition nearly six …
Two new draft guidances could affect how laboratory tests are developed in the future. Additional information available here.
On March 1, 2007, the D.C. Circuit Court of Appeals heard an oral argument in Abigail Alliance v. von Eschenbach. Previously, a divided court of appeals had ruled that where there are no other FDA-approved treatment options, a terminally ill patient’s access to investigational …
Brian Donato will be speaking at the USC Regulatory Science Program on Business Ethics in the Medical Products Industry.
Doug Farquhar will be presenting at the FDLI 5th Annual FDLI Enforcement and Litigation Conference. Compliance Officers, Manufacturers of Unapproved Drugs and Devices, or Marketers? Who will be the next FDA target? The Madison Hotel 1177 Fifteenth Street, NW Washington, DC 20005 (202) 862-1600
On July 12, 2006, Medicare finalized its Coverage with Evidence Development policy, which introduces two new concepts: Coverage with Appropriateness Determination and Coverage with Study Participation. Medicare’s Coverage with Study Participation will be of particular interest to clinical trial sponsors. Under Coverage with Study Participation, …
John Gilbert has authored a chapter on regulation of controlled substances in a new book published by Aspatore Books called Winning Legal Strategies for Food & Drug Companies: A Detailed Look at Regulations, Compliance, and Other Major Legal Issues. The book is an authoritative, …
Brian Donato is one of the faculty for the 26th Annual National Trial Advocacy College, held at University of Virginia’s School of Law in Charlottesville. He will be teaching and demonstrating “Trial Tactics and Techniques”.
In 2003 and 2005 the U.S. Department of Justice issued policy statements outlining how and when it will criminally prosecute business organizations such as corporations. These statements, which were called the “Thompson Memorandum” and the “McCallum Memorandum” (the names of the two high-ranking DOJ …
The Centers for Medicare & Medicaid Services (CMS) has issued final guidance on Medicare coverage determinations conditioned on Coverage with Evidence Development (CED) that improves on the draft guidance but may require further revision. The final guidance issued on July 12, 2006 responds to …
Yesterday, FDA announced that two proposed rules will be published in the Federal Register on December 14, 2006, that (if implemented) will “make experimental drugs more widely and easily available to seriously ill patients with no other treatment options and [will] clarify the circumstances and …
A. Wes Siegner, Jr. Speaking at FDA Functional Foods Public Hearing beginning at 9 a.m. in the Center for Food Safety and Applied Nutrition’s Harvey W. Wiley Auditorium in College Park, Maryland.
Anne Marie Murphy will be presenting at the FDLI & CDG e-conference How to do Post-Approval Registry Studies for Medical Devices 11:00 am to 1:00pm, Central Standard Time
Additional information available here.
Jeff Gibbs will be presenting at the AHLA Conference: Life Sciences – Fundamentals of Health Law Palmer House Hilton Chicago, IL
Dara Katcher will be presenting: Import & Export Requirements & International Issues at the FDLI: Introduction to Drug Law & Regulation Understanding How the Government Regulates the Drug Industry November 6-7, 2006 The Washington Court Hotel Washington, D.C.
IFT/University of Massachusetts Symposium The Path Forward for Functional Foods: Exploring Scientific and Legal Solutions for Defining Efficacy Diane McColl presenting: Demonstrating Current System for Health Claim Efficacy – Examples, Problems and Potential Solutions
The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) took effect January 2006, requiring any food that is labeled to include a declaration of the major food allergens present in the product. Although the law seems very straightforward identify the major allergens in …
Brian Donato will be lecturing at the University of Southern California, School of Pharmacy for their Regulatory Science Course: Medical Products and the Law. Mr. Donato has been a guest lecturer for USC in the past. He will be covering agency enforcement powers.
Marriott Bethesda North Hotel and Conference Center North Bethesda, Maryland Robert A. Dormer will be a speaker at the conference.
The Westin Kierland Scottsdale, Arizona
FDC Reports Audioconference Patentbusters – The Uncertain Future of Branded and Generic Drugs in the Wake of Plavix and Apotex October 12, 2006 Time: 2:00 p.m. EDT Bob Dormer is one of the featured speakers.
PLI: Pharmaceutical Law 2006 – Across The Product Life Cycle PLI New York Center New York, NY Josephine M. Torrente presenting: Overview of the Legal Issues During Research and Development
IFT: A Global Perspective on the Safety and Regulatory Approval of Food Ingredients Diane B. McColl presenting Routes to the U.S. Market Health-Related Claims in the U.S.
Developing a new drug or biological product is challenging and costly. Even minor missteps can significantly delay a product coming to market. Major missteps can add legal costs to the already mounting research and development costs that are required to prepare a new drug application …
Rep. Henry Waxman (D-CA), Sen. Charles Schumer (D-NY), and Sen. Hillary Rodham Clinton (D-NY) introduced the “Access to Life-Saving Medicines Act” last Friday. If enacted, the legislation would establish an abbreviated application approval pathway for biological products – so-called “generic biologics,” “follow-on …