FDLI Association News
Introduction to Medical Device Law in Palo Alto, Calif., next week
FDLI SmartBrief | May 29, 2012
FDLI provides advanced and introductory continuing education, helping build your professional career. Join us June 5-6 in Palo Alto, Calif., for our introductory medical device law course. For the past 15 years, FDLI's industry standard device law course has helped thousands think like an experienced professional. Whether you are a new professional in the medical device industry or seasoned regulatory affairs or legal professional needing a refresher on current FDA medical device regulatory developments, you will benefit from attending this in-depth, interactive two-day course. Attendees will hear from experts who will review the essential elements of medical device regulation. Register today.
Hot Topic: "Should surgeons be encouraged to take an active role in the implantable medical device supply chain through physician-owned entities?"
FDLI SmartBrief | May 29, 2012
In FDLI's latest Policy Forum, Joseph Truhe, senior vice president and general counsel to PDP Holdings, LLC, asks "Should surgeons be encouraged to take an active role in the implantable medical device supply chain through physician-owned entities?" Truhe discusses how the HHS OIG should provide guidance in the structuring of physician-owned device entities, and Congress and CMS should mandate transparency in the pricing of surgical implants. FDLI members: Download now. Nonmembers: Purchase for $24.95.
FDLI conferences you won’t want to miss -- members save 20% on registration
FDLI SmartBrief | May 25, 2012
FDLI provides a wide range of educational opportunities through webinars and in-person conferences. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programs include:
- Introduction to Medical Device Law and Regulation | June 5-6 | Palo Alto, Calif.
- Medical Device Regulation and Litigation Conference | June 18 | Washington, D.C.
- Regenerative Medicine Conference | June 27 | Washington, D.C., & San Francisco
- IP Throughout the Drug Development Lifecycle | July 17 | Washington, D.C.
- 2012 Brazil Conference | Sept. 10-11 | São Paulo, Brazil
- 2012 Advertising and Promotion Conference | Oct. 1-2 | Washington, D.C.
FDLI's Advertising and Promotion Conference -- call for sessions
FDLI SmartBrief | May 24, 2012
For more than 20 years, FDLI's annual event has brought together medical product industries and the agencies with regulatory authority: FDA, OIG and DOJ. Experts will explore a broad array of issues in the advertising and promotion of prescription drugs, medical devices, biologic products, and veterinary medicine. Have an idea for a session or topic? E-mail us. Save the date: Oct. 1-2, 2012.
Discover the value of FDLI membership -- join today
FDLI SmartBrief | May 23, 2012
- Stay informed on the latest legal and regulatory news with access to our bimonthly Update magazine, the twice-monthly Food and Drug Policy Forum, the quarterly Food and Drug Law Journal and more.
- Network and connect with professionals in the food and drug law community at FDLI programs and events.
- Members-only discounts on FDLI conferences and publications.
Regenerative Medicine Conference -- June 27
FDLI SmartBrief | May 23, 2012
According to former FDA Commissioner Andrew von Eschenbach, regenerative medicine has the potential to "eliminate the need for expensive supportive treatments like dialysis and organ transplants." The opportunity for innovation and development in both human and veterinary regenerative medicine is currently at an all-time high. Learn about the regulatory process for regenerative medicine at FDLI's June 27 conference, Regenerative Medicine: Key Developments in Regulation and Commercialization. Attendees will have the option to participate in the conference in either Washington, D.C., or San Francisco.
Get in-depth analysis with comprehensive books published by FDLI
FDLI SmartBrief | May 22, 2012
- Tobacco Regulation and Compliance: An Essential Resource
- Dietary Supplement Regulation: A Comprehensive Guide
- The Food Safety Modernization Act: A Comprehensive Practical Guide to the Landmark Legislation
Advanced one-day Medical Device Regulation & Litigation Conference -- June 18
FDLI SmartBrief | May 22, 2012
Hear featured luncheon speaker Clay Alspach, Counsel, House Energy and Commerce Committee, discuss the status of user fee legislation. FDA and industry stakeholders have been in intense negotiations for several months over the reauthorization for fiscal years 2013-2017 (MDUFA III). The pace of Congressional activity on the MDUFA package is picking up. Learn what factors remain in play. Learn more and register.
Introduction to Medical Device Law in Palo Alto, Calif., in June
FDLI SmartBrief | May 21, 2012
Whether you are a new professional in the medical device industry or seasoned regulatory affairs or legal professional needing a refresher on current FDA medical device regulatory developments, you will benefit from attending this in-depth, interactive two-day course. Attendees will hear from experts who will review the essential elements of medical device regulation. Details: June 5-6 in Palo Alto, Calif. Both FDLI and BayBio members receive a discounted registration rate. Register today.
Want to learn more about doing business in Brazil? Join FDLI and our sponsors.
FDLI SmartBrief | May 21, 2012
On Sept. 10 and 11, FDLI will travel to São Paulo, Brazil, to host a conference on the current legal, regulatory and economic environment for the development of pharmaceuticals, medical devices and food in both Brazil and the U.S. Don't miss this unique opportunity to network with government officials, attorneys, regulatory and compliance experts, representatives from multinational companies, consultants and academics with similar business and professional interests. View our sponsors and register to attend.
FDLI and RegLink News Sign Brazil/China Media Agreement
FDLI SmartBrief | May 18, 2012
The Food and Drug Law Institute and RegLink News announce the signing of an agreement to enhance the information provided by FDLI to its membership concerning regulatory developments in China and Brazil. Under the terms of the agreement, RegLink News will assist FDLI in populating the Institute's recently revamped website that includes a new International section. The coverage provided by RegLink News will include new laws, regulations, guidance, and other key developments in both countries. FDLI's partnership with RegLink will bolster the organization's international profile as it prepares to venture into Brazil later this year to hold its first ever conference in South America. RegLink News, a subsidiary of RegLink Associates LLC, is a relative newcomer to the established life sciences news arena, but is rapidly becoming the "go-to" source for international regulatory, commercial, reimbursement and health technology news with its comprehensive, succinct, linked-to-source coverage.
theLINK: A Comprehensive FDA Directory -- save $250 on your online subscription
FDLI SmartBrief | May 17, 2012
- Updated: Accurate and updated organizational charts -- print and share with clients and colleagues.
- Organized: 10,000 contacts at your finger tips -- theLINK will help you prepare for meetings and prepare your clients -- giving you an edge over competitors.
- Accessible: The online version is continuously updated, and available anywhere.
- Detailed: theLINK includes expanded background information on many employees, including prior experience as well as speaking engagements.
Hot topic: Interconnected Worlds of Drug, Device, Biologics, and Health Law
FDLI SmartBrief | May 16, 2012
Do you need to know more about the Sunshine Act -- and the essential role of defining "fair market value"? Need to discuss qui tam issues, the compliance traps posed by personalized medicine, or coordinating research strategies to navigate FDA and CMS product development requirements? These are just a few of the topics to be covered at this month's joint American Health Lawyers Association/Food and Drug Law Institute conference. This smaller, more boutique-style meeting, gives you the chance to expand your knowledge, and your network. Details: May 21-22 in Washington, D.C. Register now and view the agenda.
Regenerative Medicine: Key Developments in Regulation & Commercialization
FDLI SmartBrief | May 15, 2012
FDLI's one-day conference on June 27 will focus on FDA's current and evolving regulation of human regenerative products; the agency's new product approval pathway; and successful corporate strategies for the commercialization of products in this burgeoning area. Attendees will learn about factors to consider when bringing a regenerative medicine product to market and develop a better understanding of FDA's labeling, promotional and advertising requirements applicable to the market and sale of regenerative products. Attendees will also learn about the essential patent rules and pertinent regulatory issues related to commercializing products, including product qualification for appropriate government incentives and strategies to secure research and development funding. This course will be offered simultaneously in Washington, D.C., and San Francisco. Learn more online.
Medical Device Regulation and Litigation Conference -- June 18, Washington, D.C.
FDLI SmartBrief | May 15, 2012
At this advanced one-day program, attendees will hear top officials from FDA's Center for Devices and Radiological Health discuss in-depth the most significant recent medical device compliance, regulatory and enforcement actions. Medical device stakeholders will react to the center presentations and attendees will have a unique opportunity to ask questions of these center officials. The conference will also focus on hot topics in medical device regulation and policy. Learn more and register.
Experts to discuss comparative effectiveness, future of health care reform, fraud and abuse, and more
FDLI SmartBrief | May 14, 2012
Experts will discuss food and drug law and health law issues at FDLI and AHLA's joint program, The Intersecting Worlds of Drug, Device, Biologics & Health Law. Listen to former FDA Deputy Commissioner Dr. Scott Gottlieb discuss the realities of comparative effectiveness. Michael Carvin, counsel for the National Federation of Independent Business in HHS v. Florida, and constitutional scholar Marty Redish will discuss the expected impact of the Supreme Court on the future of the Affordable Care Act. Details: May 21-22 in Washington, D.C. Register now and view the agenda.
theLINK: A Comprehensive FDA Directory -- Save $250 on your online subscription
FDLI SmartBrief | May 11, 2012
FDLI's FDA directory, theLINK, is a comprehensive directory of FDA employees and select employees of other agencies including USDA, FTC, CMS, CDC and AHRQ. Its unique functionality makes it a must-have, go-to resource for companies, law firms, libraries and every food and drug law professional. theLINK is continuously updated, well organized, accessible in print and online, and has detailed information on the roles and duties of employees and offices. Learn more and save up to $250 on your new subscription.
Hot topic: Interconnected Worlds of Drug, Device, Biologics and Health Law
FDLI SmartBrief | May 11, 2012
Do you need to know more about the Sunshine Act -- and the essential role of defining "fair market value"? Need to discuss qui tam issues, the compliance traps posed by personalized medicine, or coordinating research strategies to navigate FDA and CMS product development requirements? These are just a few of the topics to be covered at this month's joint American Health Lawyers Association/Food and Drug Law Institute conference on May 21-22. This smaller, more boutique-style meeting gives you the chance to expand your knowledge, and your network. Details: May 21-22 in Washington, D.C. Register now and view the agenda.
Introduction to Medical Device Law in Palo Alto, Calif., this June
FDLI SmartBrief | May 09, 2012
Whether you are a new professional in the medical device industry or seasoned regulatory affairs or legal professional needing a refresher on current FDA medical device regulatory developments, you will benefit from attending this in-depth, interactive two-day course. Attendees will hear from experts who will review the essential elements of medical device regulation. Register today to save $100. Early-bird discount expires May 7.
Hot topic: Intersecting Worlds of Drug, Device, Biologics, and Health Law
FDLI SmartBrief | May 08, 2012
Do you need to know more about the Sunshine Act -- and the essential role of defining "fair market value"? Need to discuss qui tam issues, the compliance traps posed by personalized medicine, or coordinating research strategies to navigate FDA and CMS product development requirements? These are just a few of the topics to be covered at this month's joint American Health Lawyers Association/FDLI conference. This smaller, more boutique-style meeting, gives you the chance to expand your knowledge, and your network. Details: May 21-22 in Washington, D.C. Register now and view the agenda.
Want to learn more about doing business in Brazil? Join FDLI and our sponsors
FDLI SmartBrief | May 07, 2012
On Sept. 10-11, FDLI will travel to São Paulo, Brazil, to host a conference on the current legal, regulatory and economic environment for the development of pharmaceuticals, medical devices and food in both Brazil and the U.S. Don't miss this unique opportunity to network with government officials, attorneys, regulatory and compliance experts, representatives from multinational companies, consultants and academics with similar business and professional interests. View our sponsors and register to attend.
Get an in-depth analysis of food safety oversight
FDLI SmartBrief | May 07, 2012
As the U.S. food supply continues to globalize, and Congress expanded FDA's food safety regulation authority, a comprehensive, up-to-date resource on this game-changing law will be critical for professionals both in the U.S. and abroad. Order The Food Safety Modernization Act: A Comprehensive Practical Guide to the Landmark Legislation.
Top 20 Food and Drug Cases, 2011, & Cases to Watch, 2012 -- order now
FDLI SmartBrief | May 04, 2012
This year's Top 20 Cases features analysis and discussion of the most important food and drug cases of 2011, written by more than two dozen recognized experts in the field. The book explores the practical impact of these significant cases, as well as important settlements, administrative actions, and cases to watch in 2012 -- a must-have resource for everyone working in food and drug law. Order online.
Save $100 Introduction to Medical Device Law in Palo Alto, Calif., this June
FDLI SmartBrief | May 03, 2012
Whether you are a new professional in the medical device industry or seasoned regulatory affairs or legal professional needing a refresher on current FDA medical device regulatory developments, you will benefit from attending this in-depth, interactive two-day course. Attendees will hear from experts who will review the essential elements of medical device regulation. Register today to save $100. Early-bird discount expires May 7.
Hot off the press: 4th Edition of A Practical Guide to FDA regulation
FDLI SmartBrief | May 03, 2012
The 4th edition of FDLI's best-selling A Practical Guide to FDA's Food and Drug Law and Regulation updates and expands the widely-used 3rd edition, including coverage of new laws on biosimilars, tobacco and food safety. A Practical Guide remains the single best resource for both practitioners and academics needing a basic, easy-to-use overview of the many laws and regulations administered and enforced by FDA. This book explains the law and regulations that govern the development, marketing, and sale of food, medical products, tobacco and cosmetics in simple, nontechnical terms. Order online.
Should Congress Expand FDA Authority Over Cosmetics and, if so, How?
FDLI SmartBrief | May 02, 2012
In the latest Food and Drug Policy Forum, Thomas Cluderay, assistant general counsel at the Environmental Working Group, and Jason Rano, director of government affairs at EWG, assert that Congress should grant FDA premarket approval authority for all cosmetics ingredients. The authors posit that, with members of Congress, consumer advocates, FDA and even the cosmetics industry itself calling for expansions in the agency's regulatory authority, significant changes in the way FDA regulates cosmetics could definitely be on the horizon.
Save $100 on Introduction to Medical Device Law in Palo Alto, Calif., in June
FDLI SmartBrief | May 01, 2012
Whether you are a new professional in the medical device industry or seasoned regulatory affairs or legal professional needing a refresher on current FDA medical device regulatory developments, you will benefit from attending this in-depth, interactive two-day course. Attendees will hear from experts who will review the essential elements of medical device regulation. Register today to save $100. Early-bird discount
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