FDLI Association News
Need an overview of drug law and regulation? Register for Introduction to Drug Law and Regulation: A Program on Understanding How the Drug Industry is Regulated, Nov. 20 and 21
FDLI SmartBrief | Jul 23, 2008
Through a blend of presentations and active learning opportunities, this program provides the essential elements of the laws and regulations that affect the drug industry. The course is organized to give an overview of FDA, as well as present an outline of the history of and details specific to drug regulation: new drug approval, marketing, imports/exports and others. From the definition of "drug" to the different regulatory schemes for over-the-counter and prescription drugs, this meeting walks through the major statutory provisions and regulations, including how the FDA Amendments Act of 2007 is impacting the drug industry. View the agenda. Register online. Register by fax.
What do we have in common? A lot more than you think!
FDLI SmartBrief | Jul 23, 2008
With more than 10,000 members and affiliates, with unrivaled expertise in our varied disciplines, FDLI is at the forefront of virtually every new initiative that makes our industries more compliant, more secure and careers more rewarding. So take a moment and become an FDLI member today!
Food and Drug Law Journal -- The ultimate food and drug law resource
FDLI SmartBrief | Jul 22, 2008
FDLI's award-winning Food and Drug Law Journal offers readers scholarly, in-depth, analytical articles in the specialized area of food and drug law. This quarterly publication provides insight into government actions, courts' interpretations and industry's reactions. Internet subscriptions here. Fax subscriptions here. Learn more about becoming a Journal author.
Special offer! Advertise in Update magazine
FDLI SmartBrief | Jul 22, 2008
Take advantage of this special offer for new advertisers: Reserve advertisement space, at any size, in the September/October 2008 issue of Update magazine, with the feature topic of Personalized Medicine, and your company can place the same-size advertisement in the November/December 2008 issue of Update magazine, featuring Dietary Supplements & Functional Foods, for free! Contact Cathy Scolieri, Meetings & Advertising Manager at (202) 222-0906 or cms@fdli.org. Hurry! Time is limited to reserve your space.
Best-selling publication -- "Pharmaceutical Risk Management: Practical Applications"
FDLI SmartBrief | Jul 21, 2008
In today's Risk Evaluation and Mitigation Strategy environment, drug companies need guidance to help them succeed in pre- and post-marketing drug development and approval. The authors of "Pharmaceutical Risk Management: Practical Applications" provide you with the day-to-day guidance needed to understand, plan and implement successful risk management programs. Included are chapters on risk management's environmental and historical context; examples and case studies; strategic considerations about crisis management; and legal implications of risk management. This publication, with a foreword by Dr. Janet Woodcock, offers insight into FDA's evolving thinking on the REMS process and application. Purchase online. Purchase by fax.
Tomorrow! FDA audio forum: Science at FDA, featuring Dr. Frank Torti, Principal Deputy Commissioner and Chief Scientist, FDA, July 22
FDLI SmartBrief | Jul 21, 2008
This audio conference, scheduled from 12:30 p.m. to 2:00 p.m. EDT, will focus on the critical role of science at FDA. The program features Frank Torti, M.D., MPH, FDA's Principal Deputy Commissioner and Chief Scientist, who will outline his agenda for science at FDA, including the categories of FDA science and its underlying principles. Dr. Torti will also discuss the FDA Commissioner's Fellowship Program and the role of the newly expanded FDA Science Board. Hurry! Register today to listen to Dr. Torti and the panelists discuss the role of science at FDA. Learn more. Register online. Register by fax.
Looking for a way to gain valuable exposure to people seeking your professional services?
FDLI SmartBrief | Jul 18, 2008
The Professional Services Directory is an online search engine that contains listings of consultants, lawyers and firms. It is the perfect gateway for potential clients to find your company and learn more about your services. FDLI member law firms and consultants can list in this online publication for free. Learn about more FDLI member benefits.
Next week! FDA Audio Forum: Science at FDA, featuring Dr. Frank Torti, Principal Deputy Commissioner and Chief Scientist, FDA, July 22
FDLI SmartBrief | Jul 18, 2008
This audio conference, scheduled from 12:30 p.m. to 2:00 p.m. ET, will focus on the critical role of science at FDA. The program features Frank Torti, M.D., M.P.H., FDA's Principal Deputy Commissioner and Chief Scientist, who will outline his agenda for science at FDA, including the categories of FDA science and its underlying principles. Dr. Torti will also discuss the FDA Commissioner's Fellowship Program and the role of the newly expanded FDA Science Board. Register today to listen to Dr. Torti and the panelists discuss the role of science at FDA. Learn more. Register online. Register by fax.
Order copies of two newly revised publications -- Practical Guide and FDA Statutory Supplement
FDLI SmartBrief | Jul 17, 2008
Now available for purchase are two revised editions of FDLI's best-selling publications, "A Practical Guide to Food and Drug Law and Regulation," 3rd Edition, and "FDA Statutory Supplement," including FDA Amendments Act of 2007 and Related Sections of Additional Statutes. Expected ship date for both publications is Aug. 1, 2008. Order your copies today! Learn more.
New program! FDA Audio Forum: Science at FDA, featuring Dr. Frank Torti, Principal Deputy Commissioner and Chief Scientist, FDA, July 22
FDLI SmartBrief | Jul 16, 2008
This audio conference will focus on the critical role of science at FDA. The program features Frank Torti, M.D., M.P.H., FDA's Principal Deputy Commissioner and Chief Scientist, who will outline his agenda for science at FDA, including the categories of FDA science and its underlying principles. Dr. Torti will also discuss the FDA Commissioner's Fellowship Program and the role of the newly expanded FDA Science Board. Register today to listen to Dr. Torti and the panelists discuss the role of science at FDA. Learn more. Register online. Register by fax.
Register for the 20th Annual Advertising and Promotion conference, Sept. 8 and 9
FDLI SmartBrief | Jul 16, 2008
This conference, held in cooperation with FDA, brings together the regulated industries and the regulators who are concerned about the advertising and promotion of medical products. Included are updates from CBER, CDER, CDRH and CVM. Other sessions scheduled are FDA's Draft Guidance on Dissemination of Reprints, Controversy over Conflict of Interest in CME -- Will Industry Funding Disappear?, breakout sessions, Complying with Corporate Integrity Agreements, and more. The conference has been developed for experienced regulatory, legal, consulting, marketing and business development professionals. Read more. Register online. Register by fax. Early bird rates apply! Sponsorship and exhibiting opportunities are available.
Considering advertising in Update magazine?
FDLI SmartBrief | Jul 15, 2008
Here is a special offer for new advertisers: Reserve advertisement space, at any size, in the September/October 2008 issue of Update magazine, with the feature topic of Personalized Medicine, and your company can place the same-sized advertisement in the November/December 2008 issue of Update magazine, featuring Dietary Supplements & Functional Foods, for FREE! Contact Cathy Scolieri, Meetings & Advertising Manager at 202-222-0906 or cms@fdli.org.
Register today for Introduction to Medical Device Law and Regulation, Nov. 6 and 7
FDLI SmartBrief | Jul 15, 2008
Through a blend of presentations and active learning opportunities, you will learn the essential elements of medical device regulations in a systematic and comprehensive way. The first day will focus on the legal framework, FDA's organization and pre-market requirements; the second day will focus on postmarket requirements, the Quality System Regulation, adverse events, and promotion and advertising. The meeting will walk you through key regulations and policies while it helps you develop a better understanding of how they work. Get more information and view the list of speakers. Early-bird rates apply! Register online. Register by fax.
New program! FDA Audio Forum: Science at FDA, featuring Dr. Frank Torti, principal deputy commissioner and chief scientist, FDA, July 22
FDLI SmartBrief | Jul 14, 2008
This audio conference, scheduled from 12:30 p.m. to 2:00 p.m. ET, will focus on the critical role of science at FDA. The program features Frank Torti, M.D., M.P.H., FDA's principal deputy commissioner and chief scientist, who will outline his agenda for science at FDA, including the categories of FDA science and its underlying principles. Dr. Torti will also discuss the FDA Commissioner's Fellowship Program and the role of the newly expanded FDA Science Board. Register today to listen to Dr. Torti and the panelists discuss the role of science at FDA. Learn more. Register online. Register by fax.
Register for the 20th Annual Advertising and Promotion conference, Sept. 8 and 9 at early-bird rates
FDLI SmartBrief | Jul 14, 2008
This conference, held in cooperation with FDA, has been developed for experienced regulatory, legal, consulting, marketing and business development professionals. The meeting brings together the regulated industries and the regulators who are concerned about the advertising and promotion of medical products. Included are updates from CBER, CDER, CDRH and CVM and insights into some of the practical issues. Other sessions include DTC Advertising, FDA's Initiatives in Communicating Risk Information, Controversy over Conflict of Interest in CME, How to Conduct an Advertising Review, breakout sessions and more. Read more. Register online. Register by fax. Learn about sponsorship and exhibiting opportunities.
Registration is now open for Introduction to Medical Device Law and Regulation, Nov. 6 and 7
FDLI SmartBrief | Jul 09, 2008
Through a blend of presentations and active learning opportunities, you will learn the essential elements of medical device regulations in a systematic and comprehensive way. The first day will focus on the legal framework, FDA's organization and pre-market requirements; the second day will focus on postmarket requirements, the Quality System Regulation, adverse events, and promotion and advertising. The meeting will walk you through key regulations and policies while it helps you develop a better understanding of how they work. Get more information. Early-bird rates apply! Register online. Register by fax.
Purchase your copy of "Pharmaceutical Risk Management: Practical Applications"
FDLI SmartBrief | Jul 09, 2008
In today's Risk Evaluation and Mitigation Strategy environment, drug companies need guidance to help them succeed in pre- and post-marketing drug development and approval. The authors of "Pharmaceutical Risk Management: Practical Applications" provide you with the day-to-day guidance needed to understand, plan and implement successful risk management programs. Included are chapters on risk management's environmental and historical context; examples and case studies; strategic considerations about crisis management; and legal implications of risk management. This publication, with a foreword by Dr. Janet Woodcock, offers insight into FDA's evolving thinking on the REMS process and application. Purchase online. Purchase by fax.
Enhance your CD library
FDLI SmartBrief | Jul 08, 2008
FDLI offers recordings of its programs and audioconferences on CD, including the most recent programs: Introduction to Biotechnology Law and Regulation; FDA's Proposed Reclassification of Medical Device Data Systems; Issues and Implementation of the FDAAA of 2007: Clinical Trials Databases; Off-Label Use of Prescription Products Described in Medical Journal Reprints; and Personalized Medicine. FDLI's audio CDs, in MP-3 format, are perfect for anyone who missed a meeting or wants to share the sessions with colleagues. View the list of programs that have a CD. Purchase online. Purchase by fax.
Meet the advertising and promotion experts, Sept. 8 and 9
FDLI SmartBrief | Jul 08, 2008
Register for FDLI's 20th Annual Advertising and Promotion Conference. The program focuses on the latest issues that affect the regulation of marketing and advertising for FDA-regulated, therapeutic products. Sessions include an Update on Direct-to-Consumer Advertising, The Potential Impact of the Presidential Election on Advertising Regulation, Controversy over Conflict of Interest in CME -- Will Industry Funding Disappear? It is designed for experienced regulatory, legal, marketing, public relations and management professionals, plus advertising, legal and marketing communications consultants. Continuing Legal Education credits are pending approval. Register online. Register by fax. Early-bird rates apply! Sign on as a sponsor or exhibitor.
Pre-order copies of two newly revised publications -- Practical Guide and FDA Statutory Supplement
FDLI SmartBrief | Jul 03, 2008
Now available for purchase are two revised editions of FDLI's best-selling publications, A Practical Guide to Food and Drug Law and Regulation, 3rd Edition, and, FDA Statutory Supplement, including FDA Amendments Act of 2007 and Related Sections of Additional Statutes. Expected ship date for both publications is Aug. 1. Pre-order your copies today! Learn more.
Advertise with FDLI!
FDLI SmartBrief | Jul 02, 2008
FDLI provides you several ways to advertise: 1. Update, FDLI's bimonthly magazine, offers you the opportunity to reach nearly 9,500 of the industry's most influential decision makers in the U.S. and throughout the world. By placing an ad in Update, you will get your marketing message to professionals in the food, drug, medical device, dietary supplement, cosmetics, biologics and animal health product industries. View Update's media kit. 2. Prospectus, the weekly e-newsletter, keeps 13,000 customers in the know on all the happenings in and around FDLI. Get more information about advertising and about the special offer here.
Purchase your copy of Pharmaceutical Risk Management: Practical Applications
FDLI SmartBrief | Jul 02, 2008
In today's Risk Evaluation and Mitigation Strategy (REMS) environment, drug companies need guidance to help them succeed in pre- and post-marketing drug development and approval. The authors of Pharmaceutical Risk Management: Practical Applications provide you with the day-to-day guidance needed to understand, plan and implement successful risk management programs. Included are chapters on risk management's environmental and historical context; examples and case studies; strategic considerations about crisis management and legal implications of risk management. This publication, with a Foreword by Dr. Janet Woodcock, offers insight into FDA's evolving thinking on the REMS process and application. Purchase online. Purchase by fax.
Hurry! Last day to save up to 30% off of selected FDLI publications
FDLI SmartBrief | Jun 30, 2008
Today is the last day to receive a discount on five titles: "Legislative History of Drug Pricing"; "Bringing Your Medical Device to Market, 2nd edition"; "Promotion of Biomedical Products"; "How To Work with the FDA"; and "The Expert's Guide to Healthcare Product Due Diligence." This special offer is valid for new purchases only. Read more about these selected titles and the discounted prices. Don't delay!
A Human Resource Recruitment Tool
FDLI SmartBrief | Jun 30, 2008
FDLI's Job Board, in partnership with SmartBrief, offers members and nonmembers access to quality professionals in the food and drug industries. This service includes the opportunity to post job openings, view jobs posted, submit a resume, as well as view resumes posted. The Job Board is updated regularly as new submissions are received. While posting resumes is complimentary, only FDLI Members can submit job postings for FREE.
Register today for the 20th Annual Advertising and Promotion conference, Sept. 8 and 9
FDLI SmartBrief | Jun 25, 2008
This conference, held in cooperation with FDA, brings together the regulators and the regulated industries that are concerned about the advertising and promotion of medical products. Included are updates from CBER, CDER, CDRH and CVM. Other sessions include FDA's Draft Guidance on Dissemination of Reprints, How to Conduct an Advertising Review, Off-Label Settlements -- What is the Department of Justice Concerned About?, breakout sessions, and more. The conference has been developed for experienced regulatory, legal, consulting, marketing and business development professionals. Read more. Register online. Register by fax. Early-bird rates apply! Learn about sponsorship and exhibiting opportunities here.
New publication available for purchase! "Pharmaceutical Risk Management: Practical Applications"
FDLI SmartBrief | Jun 24, 2008
In today's Risk Evaluation and Mitigation Strategy environment, drug companies need guidance to help them succeed in pre- and post-marketing drug development and approval. The authors of "Pharmaceutical Risk Management: Practical Applications" provide you with the day-to-day guidance needed to understand, plan and implement successful risk management programs. Included are chapters on risk management's environmental and historical context; examples and case studies; strategic considerations about crisis management, and legal implications of risk management. This publication, with a Foreword by Dr. Janet Woodcock, offers insight into FDA's evolving thinking on the REMS process and application. Purchase online. Purchase by fax.
Last day to register! Introduction to Drug Law and Regulation, June 26 and 27
FDLI SmartBrief | Jun 24, 2008
By attending this program, you will learn the essential elements of the laws and regulations that affect the drug industry. With the enactment and implementation of the Food and Drug Administration Amendments Act of 2007, you will also gain a clearer understanding on how the drug industry is being impacted by this legislation. This program can help your organization stay in compliance with FDA regulations and help minimize regulatory issues and delays which can have a severe impact on your company or clients. Continuing Legal Education credits are approved. View the agenda. Register online. Register by fax.
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