FDLI Association News
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
Monograph Series
FDLI SmartBrief | Nov 05, 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.
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.
Food and Drug Law Journal -- The ultimate food and drug law resource
FDLI SmartBrief | Oct 26, 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.
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.
A human resource recruitment tool
FDLI SmartBrief | Oct 21, 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 to all, only FDLI members can submit job postings for FREE.
Attention law firm associates and regulatory affairs managers new to drug law and regulation: Attend Introduction to Drug Law and Regulation, Nov. 5 and 6
FDLI SmartBrief | Oct 21, 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 CLEs.
Hamburg and Collins to speak at Personalized Medicine Colloquium, Oct. 26 and 27, free registration!
FDLI SmartBrief | Oct 20, 2009
Convened by FDLI and AAAS, Colloquium II focuses on personalized medicine in an era of health care reform. NIH Director Collins will address the challenges of implementing personalized medicine and their implications for American health care. FDA Commissioner Hamburg will discuss how personalized medicine is aligned with FDA's public health mission. View the agenda. Register.
Attend Introduction to Medical Device Law and Regulation to learn, refresh or update yourself on all the basics of FDA regulations, including product approvals, labeling, promotion and general regulatory compliance issues
FDLI SmartBrief | Oct 19, 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. Earn CLEs!
Enhance your CD library
FDLI SmartBrief | Oct 16, 2009
FDLI offers recordings of its programs, Webinars and audioconferences on CD. 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.
"FDA's Creative Application of the Law: Not Merely a Collection of Words"
FDLI SmartBrief | Oct 16, 2009
This book examines FDA's use of the Federal Food, Drug, and Cosmetic Act as a regulatory tool for bringing about public health policy change. Citing landmark initiatives, it documents FDA's ability and willingness to accommodate the law to meet advancing science and technology needs. Also discussed are FDA's efforts to implement DSHEA and the rise of "textualism."
Personalized Medicine in an Era of Health Care Reform, Oct. 26-27
FDLI SmartBrief | Oct 15, 2009
Convened by FDLI and AAAS, Part 2 of a three-part colloquia series focuses on personalized medicine in an era of health care reform. NIH Director Dr. Francis Collins will speak about the challenges of implementing personalized medicine and their implications for American health care. Other topics include comparative effectiveness, health IT, biomarkers and avoiding adverse events. View the agenda.
Now available for download: Viewpoints on FDA
FDLI SmartBrief | Oct 15, 2009
Viewpoints on FDA: Enforcement is an invaluable resource for anyone monitoring FDA in the wake of Commissioner Hamburg's landmark speech to an FDLI audience. This downloadable PDF contains the transcript of Hamburg's speech; exclusive interviews with senior FDA officials; insightful articles on using close-out letters; reference materials; and recent enforcement actions by FTC in the dietary supplement arena. Learn more. Special pricing until Nov. 1.
New to medical devices or need a refresher? Register for Introduction to Medical Device Law and Regulation, Nov. 17 and 18
FDLI SmartBrief | Oct 14, 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 and inspections. Register online. Register by fax. Early bird rates expire! Earn CLEs!
Interested in FDA regulation of tobacco products? Register for Tobacco Product Regulation, Nov. 10
FDLI SmartBrief | Oct 13, 2009
- A high-level view of the FSPTCA, the potential effects on FDA and "year one" issues;
- Antecedents such as the 1996 Rule, previous FDA actions on nicotine-containing products and public health developments influencing FSPTCA enactment;
- Regulatory science issues including the continuum of risk and preventing youth access; and
- Ongoing litigation: Smoking Everywhere, Commonwealth Brands, Kretek.
Perplexed by Off-Label Compliance? Answer... "Off-Label Communications: A Guide to Sales & Marketing Compliance, 2nd Edition"
FDLI SmartBrief | Oct 13, 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.
Learn about FDA's first draft guidance on REMS and all the basics. Register today for Introduction to Drug Law and Regulation, Nov. 5 and 6
FDLI SmartBrief | Oct 12, 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, manufacturing, post-approval and other drug regulation topics. Read the REMS article that appeared in SmartBrief. Register.
The ultimate companion to FDA's "Orange Book"
FDLI SmartBrief | Oct 12, 2009
The "Orange Book Companion" contains extensive patent and market exclusivity information for FDA-approved drugs and is the most comprehensive, easy-to-follow companion to FDA's "Orange Book" on the market. Updated monthly, FDLI's "Orange Book Companion" is offered as a Web subscription or as a CD-ROM. Purchase your subscription online. Purchase your subscription by fax.
Appear on the attendee list -- Register today for the Enforcement and Litigation Conference, Oct. 13 and 14
FDLI SmartBrief | Oct 09, 2009
Attend this conference if you manage government and civil litigation or regulatory and health care compliance matters. Sessions include Compliance Central, Whistleblowers and Qui tam Suits; Government's Prosecution of Lawyers and Compliance Officers; Other Enforcers; Global Enforcement; Disclosures; and Economy's Impact on Enforcement. FDA, DOJ and FTC speakers are confirmed. Earn CLEs! Register.
NIH Director Francis Collins to speak on personalized medicine, Oct. 26 and 27 colloquium
FDLI SmartBrief | Oct 09, 2009
Convened by FDLI and AAAS, Part 2 of a three-part colloquia series focuses on personalized medicine in an era of health care reform. Dr. Collins will speak about the challenges of implementing personalized medicine and their implications for American health care. Other topics include comparative effectiveness, health IT, biomarkers and avoiding adverse events. View the agenda.
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