FDLI Association News
Sponsorship, exhibiting and advertising
FDLI SmartBrief | Nov 20, 2009
FDLI provides opportunities to market your organization and services to professionals in the FDA-regulated industries. By signing on as a sponsor, exhibitor or advertiser, you will reach a diverse group of food and drug decision-makers. FDLI offers a variety of packages and vehicles to help you expand your current and prospective business relationships. Learn more.
CD library and downloadable products
FDLI SmartBrief | Nov 20, 2009
FDLI records many of its programs, including the recently held Tobacco Legislation and Regulation conference. FDLI's audio CDs, in MP-3 format, are perfect for anyone who missed a meeting or wants to share the sessions with colleagues. Included in this library is the downloadable PDF of Viewpoints on FDA: Enforcement containing the transcript of Commissioner Hamburg's enforcement speech, interviews with senior FDA officials and articles on recent enforcement actions.
Food and Drug Law and Regulation, Dec. 16
FDLI SmartBrief | Nov 19, 2009
FDLI's distance-learning lecture series will discuss the chapters of the best-selling treatise, Food and Drug Law and Regulation. The Dec. 16 presentation is on "Drugs: General Requirements: Jurisdiction, Definitions, Adulteration and Misbranding, Imports and Exports." This series is developed for attorneys, consultants and academics who want to learn about food and drug law in general or clarify understanding of a particular area. Register.
Perplexed by off-label communication compliance? Then consider "Off-Label Communications: A Guide to Sales & Marketing Compliance, 2nd Edition"
FDLI SmartBrief | Nov 19, 2009
The second edition features brand-new practical guidance from industry insiders on these watershed events: FDA Final Guidance on Good Reprint Practices; Cephalon ($413 million), Eli Lilly ($1.4 billion); Fraud Enforcement and Recovery Act; Supreme Court's ruling in Wyeth v. Levine. Learn more. Order your copy.
Monograph Series
FDLI SmartBrief | Nov 18, 2009
FDLI's Monograph Series is a groundbreaking set of six special reports specifically designed for attorneys, regulatory affairs and compliance specialists, manufacturers and consultants in the ever-changing food and drug field. The monographs are designed to provide you with inside information and proprietary analysis to enable you to advise your clients or help your company comply with vexing issues, regulations or guidance. View the titles. Purchase the series.
Call for sessions: FDLI's 53rd Annual Conference, April 22 to 23
FDLI SmartBrief | Nov 18, 2009
FDLI needs your input. You are invited to submit a proposal for a 1.5 hour, concurrent breakout session scheduled during FDLI's Annual Conference in Washington, D.C. Your proposal should include a session title, two- to three-sentence description and proposed participants. Submit your proposal to smg@fdli.org no later than Dec. 18 using the subject line: Call for Sessions. Proposal submission does not guarantee selection.
Food and Drug Law Journal -- The ultimate food and drug law resource
FDLI SmartBrief | Nov 17, 2009
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, click here. Fax subscriptions, click here. Learn more about becoming a Journal author.
Attention law firm associates, regulatory affairs managers and Capitol Hill staffers new to food law and regulation: Attend Introduction to Food Law and Regulation, Jan. 25 and 26
FDLI SmartBrief | Nov 17, 2009
During this interactive program, you will learn the essential elements of food law and regulation while acquiring an orientation to how FDA, USDA and FTC promulgate and enforce regulations. Topics include food safety and misbranding, dietary supplements, advertising, inspections and enforcement. Register.
How does the federal government regulate health-related software? Purchase your copy of Biomedical Software Regulation
FDLI SmartBrief | Nov 16, 2009
As health information technology becomes a centerpiece in the administration's reform initiatives, there is much to learn. This guide summarizes regulations promulgated by FDA and CMS, and provides reference materials and documents for use by regulatory and compliance specialists. It covers regulation of software: validation; medical imaging; electronic record-keeping; clinical trials; and laboratory information management systems. Purchase today.
Looking for an expert? Check FDLI's Professional Services Directory
FDLI SmartBrief | Nov 16, 2009
The Professional Services Directory is an online search engine that contains exclusive listings of FDLI members who are consultants and lawyers active in our regulatory field, including areas of specialty. It is the perfect gateway for potential clients to find your organization and learn more about your services. Listings for FDLI member lawyers and consultants in this online publication are FREE.
Call for sessions: FDLI's 53rd Annual Conference, April 22 and 23
FDLI SmartBrief | Nov 13, 2009
You are invited to submit a proposal for a 1.5-hour, concurrent, breakout session scheduled during FDLI's Annual Conference in Washington, D.C. Your proposal is to include a session title, two- to three-sentence description and proposed participants. Submit your proposal to smg@fdli.org no later than Dec. 18 using the subject line: Call for Sessions. Proposal submission does not guarantee selection.
Global Pharmacovigilance Laws & Regulations: The Essential Reference
FDLI SmartBrief | Nov 12, 2009
Despite the need for greater harmonization of pharmacovigilance requirements worldwide, regulatory requirements continue to diverge. This book details the pharmacovigilance systems of more than a dozen countries. This landmark resource is designed for attorneys, pharmacovigilance specialists and others in postmarketing surveillance. Learn more. Purchase your copy.
Introduction to Food Law and Regulation, Jan. 25 and 26, a primer for legal and regulatory professionals
FDLI SmartBrief | Nov 12, 2009
The food industry has seen much change this past year, with headlines about food safety appearing regularly and pending new legislation anticipated. During this interactive program, you will learn the essential elements of food law and regulation while acquiring an orientation to how FDA, USDA and FTC promulgate and enforce regulations. Register.
Next week! 510(k)s, PMAs and marketing -- some of the topics presented during Introduction to Medical Device Law and Regulation, Nov. 17 and 18
FDLI SmartBrief | Nov 11, 2009
By attending Introduction to Medical Device Law and Regulation, you will obtain a clearer understanding of the essential elements of medical device regulation. Nov. 17 focuses on the legal framework and premarket requirements; Nov. 18 sessions include the QSR, adverse events, marketing and inspections. Register. Earn CLE's.
Pharmaceutical Risk Management: Practical Applications
FDLI SmartBrief | Nov 11, 2009
In today's REMS environment, drug companies need guidance to help them succeed in pre- and post-marketing drug development and approval. Pharmaceutical Risk Management provides you with day-to-day guidance needed to understand, plan and implement successful risk management programs. Chapters include risk management's environmental and historical context, examples and case studies, strategic considerations about crisis management, and legal implications. Purchase. A REMS conference is planned for February 2010.
A human resource recruitment tool
FDLI SmartBrief | Nov 10, 2009
FDLI's Job Board, in partnership with SmartBrief, offers members and nonmembers access to quality food and drug professionals. 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.
Winckler named FDLI president and CEO
FDLI SmartBrief | Nov 09, 2009
Susan C. Winckler has been selected as the new president and CEO of the Food and Drug Law Institute, effective Nov. 6. Winckler replaced James J. Kelly, who announced his departure from FDLI in late summer. From January 2007 until June 2009, Winckler, a pharmacist and attorney, served as chief of staff at the Food and Drug Administration. Prior to joining FDA, Winckler served in various positions with the American Pharmacists Association (APhA), including vice president for Policy and Communications and staff counsel. For more information, visit www.fdli.org.
Tomorrow! Tobacco Product Regulation conference, Nov. 10
FDLI SmartBrief | Nov 09, 2009
This conference brings together speakers with diverse vantage points discussing the topics:
- Origins of the Family Smoking Prevention and Tobacco Control Act of 2009
- The statute's key provisions and challenges facing FDA
- The scientific basis for tobacco regulation
- Legal issues raised by the legislation and in pending litigation
- The regulatory challenges facing FDA, industry and the states
Register today! Earn CLEs!
Speakers are confirmed for the Nov. 10 Tobacco Product Regulation conference!
FDLI SmartBrief | Nov 06, 2009
Attend this conference if you are involved in FDA regulation of tobacco products. Topics include legislation origins, the statute's key provisions, challenges facing FDA, scientific basis for tobacco regulation, legal issues raised by the legislation and, in pending litigation, regulatory challenges. Register online. Register by fax. Earn CLEs.
The all-inclusive desk reference guide, Food and Drug Law and Regulation
FDLI SmartBrief | Nov 06, 2009
Written and edited by the most experienced food and drug attorneys in the U.S., Food and Drug Law and Regulation is the definitive resource on food and drug law. Chapters include penetrating analysis and current legal citations that will expedite your legal research. Purchase online. Purchase by fax.
Mark your 2010 calendar with FDLI program dates!
FDLI SmartBrief | Nov 05, 2009
Introduction to Food Law and Regulation, Jan. 25 to 26
Introduction to Drug Law and Regulation, Feb. 17 to 18
Introduction to Medical Device Law and Regulation, March 8 to 9
53rd Annual Conference, April 22 to 23
Attend Introduction to Medical Device Law and Regulation to learn, refresh or update yourself on FDA regulations, including product approvals, labeling, promotion and general regulatory compliance issues, Nov. 17 and 18
FDLI SmartBrief | Nov 04, 2009
By attending Introduction to Medical Device Law and Regulation, you will obtain a clearer understanding of the essential elements of medical device regulation. Nov. 17 focuses on the legal framework and premarket requirements; Nov. 18 addresses the QSR, adverse events and inspections. Register.
Perplexed by off-label compliance? Answer ... "Off-Label Communications: A Guide to Sales & Marketing Compliance, 2nd Edition"
FDLI SmartBrief | Nov 04, 2009
The second edition features brand-new practical guidance from industry insiders on these watershed events: FDA Final Guidance on Good Reprint Practices; Cephalon ($413 million), Eli Lilly ($1.4 billion); Fraud Enforcement and Recovery Act; Supreme Court's ruling in Wyeth v. Levine. Learn more. Order your copy.
Downloadable products and CD library
FDLI SmartBrief | Nov 03, 2009
Viewpoints on FDA: Enforcement is a downloadable PDF containing the transcript of Commissioner Hamburg's Aug. 6 speech, interviews with senior FDA officials, and articles on close-out letters and recent enforcement actions. If you missed the Oct. 13 and 14 Enforcement conference, download the Oct. 13 Compliance Central session audio. FDLI offers recordings of other programs on CD. View the list of programs that have a CD.
This Thursday and Friday -- Introduction to Drug Law and Regulation, Nov. 5 and 6 -- Earn CLEs
FDLI SmartBrief | Nov 03, 2009
Introduction to Drug Law and Regulation covers the essential elements of the laws and regulations that affect the drug industry. The course provides an overview of FDA and details of new drug applications, ANDAs, OTC, manufacturing, marketing, imports/exports and other drug regulation topics. Breakout sessions provide practical application of topics. Register today.
How does the federal government regulate software? Purchase your copy of "Biomedical Software Regulation"
FDLI SmartBrief | Nov 02, 2009
As health information technology becomes a centerpiece in the administration's reform initiatives, there is much to learn. This guide summarizes regulations promulgated by FDA and CMS, and provides reference materials and documents for use by regulatory and compliance specialists. It covers regulation of software: validation; medical imaging; electronic recordkeeping; clinical trials; and laboratory information management systems. Purchase today.
Next week! Tobacco Product Regulation conference, Nov. 10
FDLI SmartBrief | Nov 02, 2009
This conference brings together various perspectives on the topics:
Looking for an expert? Check FDLI's Professional Services Directory
FDLI SmartBrief | Oct 29, 2009
The Professional Services Directory is an online search engine that contains exclusive listings of FDLI members who are consultants and lawyers active in our regulatory field, including their areas of specialty. It is the perfect gateway for potential clients to find your organization and learn more about your services. FDLI member lawyers and consultants can list in this online publication for FREE.
510(k)s, PMAs and Marketing -- some of the topics presented during Introduction to Medical Device Law and Regulation, Nov. 17 and 18
FDLI SmartBrief | Oct 28, 2009
By attending Introduction to Medical Device Law and Regulation, you will obtain a clearer understanding of the essential elements of medical device regulation. Nov. 17 focuses on the legal framework and premarket requirements; Nov. 18 sessions include the QSR, adverse events, marketing and inspections. Register online. Register by fax. Earn CLE's.
"Global Pharmacovigilance Laws & Regulations: The Essential Reference"
FDLI SmartBrief | Oct 27, 2009
Despite the need for greater harmonization of pharmacovigilance requirements worldwide, regulatory requirements continue to diverge. This book details the pharmacovigilance systems of more than a dozen countries. This landmark resource is designed for attorneys, pharmacovigilance specialists and others in postmarketing surveillance. Learn more. Purchase your copy.
Need an overview or refresher of the issues involved in FDA's regulation of drugs? Attend Introduction to Drug Law and Regulation, Nov. 5 and 6
FDLI SmartBrief | Oct 26, 2009
Introduction to Drug Law and Regulation covers the essential elements of the laws and regulations that affect the drug industry. The course provides an overview of FDA and details of new drug applications, ANDAs, manufacturing, imports/exports and other drug regulation topics. Register today. Earn CLE's.
Tobacco Product Regulation conference, Nov. 10
FDLI SmartBrief | Oct 23, 2009
Attend this conference if you are a food and drug lawyer, consultant, public interest group representative or non-food and drug lawyer involved in FDA regulation of tobacco products. Topics include legislation origins, scientific and regulatory aspects, including legal issues such as the First Amendment, FSPTC themes and first issues FDA must address. Register online. Register by fax.
Enforcement: Viewpoints on FDA, downloadable audio, CD
FDLI SmartBrief | Oct 22, 2009
Viewpoints on FDA: Enforcement is a downloadable PDF containing the transcript of Commissioner Hamburg's Aug. 6 speech, exclusive interviews with senior FDA officials, insightful articles on using close-out letters, reference materials and recent enforcement actions. Did not attend the Enforcement and Litigation conference? Download the Oct. 13 Compliance Central session audio. Purchase the conference CD containing the audio of the entire conference and the handouts.
Perplexed by Off-Label Compliance? Answer ... "Off-Label Communications: A Guide to Sales & Marketing Compliance, 2nd Edition"
FDLI SmartBrief | Oct 22, 2009
The second edition features brand-new practical guidance from industry insiders on these watershed events: FDA Final Guidance on Good Reprint Practices; Cephalon ($413 million), Eli Lilly ($1.4 billion); Fraud Enforcement and Recovery Act; Supreme Court's ruling in Wyeth v. Levine. Learn more. Order your copy.
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