FDLI Association News
Registration is open for "Pharmaceutical Risk Management" conference
FDLI SmartBrief | Nov 21, 2008
The enactment of REMS -- Risk Evaluation and Mitigation Strategy -- has changed the world of drug development and product marketing. Pharmaceutical and biotechnology companies who don't thoroughly understand the strategies and tactics of REMS do so at their own peril. At this conference, Jan. 13, 2009, experts in the field will provide theoretical and practical enlightenment while engaging the audience to become part of the discussion. Learn more. Register online. Register by fax.
Preview now FDLI's "A Practical Guide to Food and Drug Law and Regulation, 3rd Edition"
FDLI SmartBrief | Nov 21, 2008
This significantly updated third edition, including incorporation of the Food and Drug Administration Amendments Act and other new laws passed since 2002, provides readers a practical explanation of food and drug law and regulations in simple, nontechnical terms. This FDLI best seller includes three new chapters: Combination Products, Pharmacovigilance and Regulation of Medical Research. "A Practical Guide" remains the single best resource for anyone needing a basic, uncomplicated understanding of the myriad requirements enforced by FDA. Preview now! Purchase through FDLI's Web site. Purchase by using FDLI's fax order form.
Attention law school professors, students and academics: FDLI announces the 2008-2009 H. Thomas Austern Memorial Writing Competitions
FDLI SmartBrief | Nov 20, 2008
As part of its academic mission, FDLI sponsors the H. Thomas Austern Memorial Writing Competitions to encourage law students interested in the areas of law that affect foods, drugs, devices, cosmetics and biologics. Additionally, winning papers will be considered for publication in the Food and Drug Law Journal. Entrants must be currently enrolled in a JD program at any of the nation's law schools.
New program! "New Administration Forecast -- Focusing on Food Safety Legislation, Funding, FDA Initiatives and Pending Nutrition Issues," Dec. 15, 1 p.m. to 2:30 p.m. EST
FDLI SmartBrief | Nov 20, 2008
What can the food industry expect from FDA during the new administration? An elite panel of experts, moderated by Joseph Levitt of Hogan & Hartson and former FDA CFSAN director, will look into their crystal balls and forecast what to expect in terms of new food safety legislation, new funding for FDA and new activities in the nutrition area. We will also hear from inside FDA on how the agency is preparing for the transition. Read more. Register online.
Register by fax.
Understanding roles, responsibilities and risks affecting drug abuse: Register today for "Regulation of Controlled Substances and Diversion Control conference;" receive CLEs
FDLI SmartBrief | Nov 19, 2008
Prescription drug abuse is a growing problem in the U.S. as diversion and abuse of drug products continue to escalate. How can patients, who have legitimate medical conditions, obtain drug therapies that contain controlled substances without being hindered by controls intended to minimize diversion? How is REMS impacting controlled substances? This conference, Dec. 4 and 5, will explore how DEA and FDA seek to balance the need to ensure the availability of medicines while reducing the risk of diversion and abuse. Learn more. Register online. Register by fax. Pending state approval, CLEs will be awarded.
Newly scheduled meeting! "Introduction to Food Law and Regulation"
FDLI SmartBrief | Nov 19, 2008
During this interactive program, Jan. 27 and 28, 2009, you will learn the essential elements of food law and regulation while acquiring an orientation to administrative agencies and furthering your understanding of how FDA, USDA and FTC promulgate and enforce regulations. This meeting will provide you with a context for keeping current with emerging issues of concern to food manufacturers, regulators and consumers, such as claims, safety, imports, allergens, advertising and bioterrorism measures. Pending state approval, Continuing Legal Education credits are will be awarded. Read more. Register online. Register by fax.
Looking to expand your career into food and drug law and regulation and need a good overview? Register today for this once-a-year offering of "Fundamentals of Food and Drug Law"
FDLI SmartBrief | Nov 18, 2008
By attending this program, Dec. 2 and 3, you will learn the fundamentals of the laws and regulations that affect all FDA-regulated products: foods, drugs, biologics, medical devices and radiological health, veterinary products, dietary supplements and cosmetics. International issues, the jurisdiction of other government agencies and details specific to developing, processing, labeling, distributing and competitively marketing various FDA-regulated products will also be addressed. This course is designed to provide you with an overall landscape of food and drug law and how the FDA Amendments Act of 2007 is impacting the industries. CLE credits available pending state approvals. Learn more. Register online. Register by fax.
Call for sessions: FDLI's 52nd Annual Conference
FDLI SmartBrief | Nov 18, 2008
You are invited to submit a proposal for a 1.5 hour, concurrent session scheduled during FDLI's Annual Conference, April 22 to 23, 2009, in Washington, D.C. The theme for this Annual Conference is, "A New Era for America's Health: Opportunities and Challenges Facing FDA and New Administration." Your submission is to include a title, two- to three-sentence description and proposed participants. Submit your proposal to smg@fdli.org no later than Dec. 19, using the subject line: Call for Sessions. Proposal submission does not guarantee selection. FDLI will review submissions and consider how proposed sessions complement the Annual Conference. You will be notified if your session has been selected.
This week! Register now for Introduction to Drug Law and Regulation; receive CLEs!
FDLI SmartBrief | Nov 17, 2008
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 clinical trial reporting. This program, Nov. 20 and 21, can help you and your organization stay in compliance with FDA regulations and help minimize regulatory problems. It provides an overview of FDA and outlines the history of and details specific to drug regulation. CLE credits are approved. View the agenda and list of speakers. Register online. Register by fax. Read the article featured in SmartBrief.
New -- the essential and comprehensive treatise: FDLI's "Food and Drug Law and Regulation"
FDLI SmartBrief | Nov 17, 2008
This soon-to-be released publication is the ultimate and definitive resource on food and drug law. Each chapter includes penetrating analysis and current legal citations, which will expedite your legal research. Written and edited by the most experienced food and drug attorneys in the U.S., "Food and Drug Law and Regulation" is the most complete single volume ever published in this complex field of law. A preview is available online. Purchase your copy today at a special pre-publication rate as quantities are limited! Expected ship date is December 2008. Purchase through FDLI's Web site. Purchase by using FDL's fax order form.
FDA rejected clinical data on a experimental drug, as featured Nov. 5 in SmartBrief. Learn about the NDA process and "comparability" and the entire area of Drug Law by attending "Introduction to Drug Law and Regulation"
FDLI SmartBrief | Nov 14, 2008
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 clinical trial reporting. This program can help you and your organization stay in compliance with FDA regulations and help minimize regulatory problems. It provides an overview of FDA and outlines the history of and details specific to drug regulation. CLE credits are approved. View the agenda and list of speakers. Register online. Register by fax. Read the article featured in SmartBrief.
New meeting! Registration now open for "Introduction to Food Law and Regulation"
FDLI SmartBrief | Nov 14, 2008
During this interactive program, Jan. 27 and 28, 2009, you will learn the essential elements of food law and regulation while acquiring an orientation to administrative agencies and furthering your understanding of how FDA, USDA and FTC promulgate and enforce regulations. This meeting will provide you with a context for keeping current with emerging issues of concern to food manufacturers, regulators and consumers, such as claims, safety, imports, allergens, advertising and bioterrorism measures. Pending state approval, Continuing Legal Education credits will be available. Read more. Register online. Register by fax.
Just scheduled! Pharmaceutical Risk Management conference
FDLI SmartBrief | Nov 13, 2008
The enactment of REMS -- Risk Evaluation and Mitigation Strategy -- has changed the world of drug development and product marketing. Pharmaceutical and biotechnology companies that don't thoroughly understand the strategies and tactics of REMS do so at their own peril. At this conference, Jan. 13, 1009, experts in the field will provide theoretical and practical enlightenment while engaging the audience to become part of the discussion. Learn more. Register online. Register by fax.
A must-have publication: FDLI's "Food and Drug Law and Regulation"
FDLI SmartBrief | Nov 13, 2008
This manual is the ultimate and definitive resource tool on food and drug law, presenting penetrating analysis, explanation and discussion of virtually all aspects of food and drug law and regulation. Each chapter includes legal citations, which will expedite your legal analysis and research. Written and edited by the most experienced food and drug attorneys in the U.S., "Food and Drug Law and Regulation" is the most comprehensive treatise ever published covering this complex field of law. A preview is available online. Purchase your copy at a special pre-publication rate as quantity is limited! Expected ship date is January 2009. Purchase through FDLI's Web site. Purchase using FDLI's fax order form.
Next week! Tom Scully, former CMS administrator, to speak at "Better Understanding CMS and Its Relationship to FDA" conference
FDLI SmartBrief | Nov 12, 2008
FDA has been and remains the focus of all new drug and device approvals and postapproval monitoring of existing health care products and technologies; however, FDA does not rule alone. CMS impacts all decisions regarding drug development, clinical trials and postapproval uses and reimbursements. This conference, Nov. 18 and 19, will give attendees insight into this "real time" change, focusing on the evolving role of CMS: where "safety and effectiveness" meet "reasonable and necessary." Continuing Legal Educations credits are approved. View the agenda and make your hotel sleeping room reservation. Register online. Register by fax.
The ultimate companion to FDA's Orange Book
FDLI SmartBrief | Nov 12, 2008
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, the "Orange Book Companion" is offered as a Web subscription or as a CD-ROM. Purchase your subscription online. Purchase your subscription by fax.
Drugs! Explore how DEA and FDA seek to balance the need to ensure the availability of medicines while reducing the risk of diversion and abuse. Register today for "The Regulation of Controlled Substances and Diversion Control!"
FDLI SmartBrief | Nov 11, 2008
This conference, Dec. 4 and 5, will explore current and emerging issues in the regulation of controlled substances. Sessions include federal, state and international scheduling processes, registration, Risk Management Plans, and investigations and enforcement actions with an emphasis on the how the law and regulations, as well as how the DEA and FDA, seek to balance the need to ensure the availability of these medicines while reducing the risk of diversion and abuse. Learn more. Register online. Register by fax. Pending state approval, CLE's will be awarded. Those attending this program are invited to the members only FDLI Annual Holiday and Awards Reception on Dec. 4.
Come learn, get involved, make a difference!
FDLI SmartBrief | Nov 11, 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! If you join before Nov. 30, you will be invited as guest to FDLI's Holiday and Awards Reception on Dec. 4!
Are you a new law firm associate, regulatory affairs manager or Capitol Hill staffer and need a good overview of food and drug law and regulation? Register for "Fundamentals of Food and Drug Law"
FDLI SmartBrief | Nov 10, 2008
By attending this program, Dec. 2 and 3, you will learn the fundamentals of the laws and regulations that affect all FDA-regulated products: foods, drugs, biologics, medical devices and radiological health, veterinary products, dietary supplements and cosmetics. International issues, the jurisdiction of other government agencies and details specific to developing, processing, labeling, distributing and competitively marketing various FDA-regulated products will also be addressed. This course is designed to provide you with an overall landscape of food and drug law and how the FDA Amendments Act of 2007 is impacting the industries. CLE credits available pending state approvals. Learn more. Register online. Register by fax.
Attention law school professors, bookstore managers, purchasing agents and librarians: Preview and purchase FDLI's "A Practical Guide to Food and Drug Law and Regulation," 3rd Edition
FDLI SmartBrief | Nov 10, 2008
This significantly updated third edition, including incorporation of the Food and Drug Administration Amendments Act and other new laws passed since 2002, provides readers a practical explanation of food and drug law and regulations in simple, nontechnical terms. This FDLI best-seller includes three new chapters: Combination Products, Pharmacovigilance and Regulation of Medical Research. "A Practical Guide" remains the single best resource for anyone needing a basic, uncomplicated understanding of the myriad requirements enforced by FDA. Preview now! Purchase through FDLI's Web site. Purchase by using FDLI's fax order form.
Could not attend an FDLI event? Purchase the audio CD!
FDLI SmartBrief | Nov 07, 2008
FDLI records many of its programs, audioconferences and webinars on CD, including the recently held Import Regulations and Postmarket Authority meetings. FDLI's audio CDs, in MP3 format, are perfect for anyone who missed a meeting or wants to share the sessions with colleagues. Enhance your CD library today! View the list of programs that have a CD. Purchase online. Purchase by fax.
Warning letters sent to a pharmaceutical company, as featured on Oct. 29 in SmartBrief. Learn how to avoid them by attending "Introduction to Drug Law and Regulation"
FDLI SmartBrief | Nov 07, 2008
From the definition of "drug" to the different regulatory schemes for over-the-counter and prescription drugs, this meeting, Nov. 20 and 21, walks through the major statutory provisions and regulations, including how the FDA Amendments Act of 2007 is impacting clinical trial reporting. This program can help you and your organization stay in compliance with FDA regulations and help minimize regulatory problems. It provides an overview of FDA and outlines the history of and details specific to drug regulation. CLE credits are approved. View the agenda and list of speakers. Register online. Register by fax. Read the article featured in SmartBrief.
Do you need an overview of food and drug law and regulation? Register today for "Fundamentals of Food and Drug Law"
FDLI SmartBrief | Nov 06, 2008
By attending this program, Dec. 2 and 3, you will learn the fundamentals of the laws and regulations that affect all FDA-regulated products: foods, drugs, biologics, medical devices and radiological health, veterinary products, dietary supplements and cosmetics. International issues, the jurisdiction of other government agencies and details specific to developing, processing, labeling, distributing and competitively marketing various FDA-regulated products will also be addressed. This course is designed to provide you with an overall landscape of food and drug law and how the FDA Amendments Act of 2007 is impacting the industries. CLE credits available pending state approvals. Read more. Register online. Register by fax.
"FDA's Creative Application of the Law: Not Merely a Collection of Words," 2nd Edition
FDLI SmartBrief | Nov 06, 2008
"FDA's Creative Application of the Law: Not Merely a Collection of Words" 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, this book documents FDA's ability and, more importantly, its willingness to accommodate the law to meet the needs of advancing science and technology. This second edition contains two new chapters: one focuses on FDA's efforts to implement the Dietary Supplement Health and Education Act, while the other touches upon another development in FDA regulation -- the rise of "textualism." Submit Internet orders here. Get the form for fax orders here.
HHS' Thomas Barker, FDA's Jeffrey Shuren, and CMS' Jeffrey Kelman, Steven Phurrough and Jean Slutsky are confirmed speakers for FDLI's conference, "Better Understanding CMS and Its Relationship to FDA"
FDLI SmartBrief | Nov 05, 2008
FDA has been and remains the focus of all new drug and device approvals and postapproval monitoring of existing health care products and technologies; however, FDA does not rule alone. CMS impacts all decisions regarding drug development, clinical trials and postapproval uses and reimbursements. This conference, Nov. 18 and 19, will give attendees insight into this "real time" change, focusing on the evolving role of CMS: where "safety and effectiveness" meet "reasonable and necessary." Continuing Legal Educations credits are approved. View the agenda and make your hotel sleeping room reservation. Early-bird rates apply! Register online. Register by fax.
Update magazine -- available by subscription for nonmembers
FDLI SmartBrief | Nov 05, 2008
Update brings you the latest news from FDLI and the industry, featuring viewpoints on industry-specific trends, articles on varied topics of regulatory concern, changes at FDA, news about FDLI activities and more. The upcoming July/August issue features reimbursement topics. Published bi-monthly, Update magazine is complimentary to all individuals within FDLI member organizations. Yearly subscriptions are available to nonmembers. The upcoming issue feature dietary supplement articles. Purchase your subscription online. Purchase your subscription by fax. Read more about FDLI member benefits.
Attention new law firm associates and regulatory affairs personnel practicing in the medical device arena: Register for Introduction to Medical Device Law and Regulation, Nov. 6 and 7
FDLI SmartBrief | Nov 04, 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 premarket requirements; the second day will focus on postmarket requirements, the Quality System Regulation, adverse events, and promotion and advertising and warning letters. Read the SmartBrief feature. CLE credits are approved! View the agenda and list of speakers. Register online. Register by fax.
Preview and purchase FDLI's A Practical Guide to Food and Drug Law and Regulation, 3rd Edition
FDLI SmartBrief | Nov 03, 2008
This significantly updated third edition, including incorporation of the Food and Drug Administration Amendments Act and other new laws passed since 2002, provides readers a practical explanation of food and drug law and regulations in simple, nontechnical terms. This FDLI best-seller includes three new chapters: Combination Products, Pharmacovigilance and Regulation of Medical Research. A Practical Guide remains the single best resource for anyone needing a basic, uncomplicated understanding of the myriad requirements enforced by the FDA. Preview now! Purchase through FDLI's Web site. Purchase by using FDLI's fax order form.
Learn how to work with DEA: The other drug regulatory agency. Register at early-bird rates for The Regulation of Controlled Substances and Diversion Control
FDLI SmartBrief | Nov 03, 2008
This conference, Dec. 4 and 5, will explore current and emerging issues in the regulation of controlled substances. Sessions include federal, state and international scheduling processes, registration, Risk Management Plans, and investigations and enforcement actions, with an emphasis on how the law and regulations, as well as how the DEA and FDA, seek to balance the need to ensure the availability of these medicines while reducing the risk of diversion and abuse. Learn more. Register online. Register by fax. Pending state approval, CLEs will be awarded. Mark your calendar for FDLI's Dec. 4 Holiday Networking and Awards Reception! Become a sponsor!
Attention new law firm associates and regulatory affairs personnel practicing in the pharmaceutical arena: "Register today for Introduction to Drug Law and Regulation"
FDLI SmartBrief | Oct 31, 2008
From the definition of "drug" to the different regulatory schemes for over-the-counter and prescription drugs, this meeting, Nov. 20 and 21, walks through the major statutory provisions and regulations, including how the FDA Amendments Act of 2007 is impacting clinical trial reporting. This program can help you and your organization stay in compliance with FDA regulations and help minimize regulatory problems. It provides an overview of FDA and outlines the history of and details specific to drug regulation. CLE credits are approved. View the agenda and list of speakers. Register online. Register by fax.
"Better Understanding CMS and Its Relationship to FDA -- The Regulation of, and Payments for, Drugs and Medical Devices": Register today for this conference
FDLI SmartBrief | Oct 30, 2008
FDA has been and remains the focus of all new drug and device approvals and postapproval monitoring of existing health care products and technologies; however, FDA does not rule alone. CMS impacts all decisions regarding drug development, clinical trials, and postapproval uses and reimbursements. This conference, Nov. 18 to 19, will give attendees insight into this "real time" change, focusing on the evolving role of CMS: where "safety and effectiveness" meet "reasonable and necessary." Continuing Legal Educations credits are approved. View the agenda. Register online. Register by fax.
Sponsorship, exhibiting and advertising
FDLI SmartBrief | Oct 30, 2008
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.
Preview, purchase "A Practical Guide to Food and Drug Law and Regulation," 3rd Edition
FDLI SmartBrief | Oct 29, 2008
This significantly updated third edition, including incorporation of the Food and Drug Administration Amendments Act and other new laws passed since 2002, provides readers a practical explanation of food and drug law and regulations in simple, nontechnical terms. This FDLI best-seller includes three new chapters: Combination Products, Pharmacovigilance and Regulation of Medical Research. "A Practical Guide" remains the single best resource for anyone needing a basic, uncomplicated understanding of the myriad requirements enforced by FDA. Preview now! Purchase through FDLI's Web site. Purchase by using FDLI's fax order form.
Register open for "The Regulation of Controlled Substances -- Balancing Medical Need and Diversion Control" conference! Early-bird rates apply!
FDLI SmartBrief | Oct 29, 2008
This conference, Dec. 4 and 5, will explore current and emerging issues in the regulation of controlled substances. Sessions include federal, state and international scheduling processes, registration, Risk Management Plans, and investigations and enforcement actions, with an emphasis on the how the law and regulations, as well as how the DEA and FDA, seek to balance the need to ensure the availability of these medicines while reducing the risk of diversion and abuse. Learn more. Register online. Register by fax. Mark your calendar for FDLI's Dec. 4 Holiday Networking and Awards Reception!
"Food and Drug Law Journal" -- The ultimate food and drug law resource
FDLI SmartBrief | Oct 28, 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.
As reported here on Oct 20, FDA should adopt a policy on imported devices that reduces risk in a product's life cycle. Learn about import, export and international issues by attending "Introduction to Medical Device Law and Regulation," Nov. 6 and 7
FDLI SmartBrief | Oct 28, 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 premarket requirements; the second day will focus on the Quality System Regulation, adverse events, promotion and advertising, and warning letters. Read the SmartBrief feature. CLE credits are approved! View the agenda and list of speakers. Register online. Register by fax.
Best seller! "Off-Label Communications: A Guide to Sales and Marketing Compliance"
FDLI SmartBrief | Oct 27, 2008
Drugs, biologics and medical devices increasingly are used to treat patients in ways that were not specifically approved by FDA. While FDA does not regulate off-label use nor forbid off-label prescribing, it does heavily regulate off-label promotion. This new FDLI publication provides comprehensive, practical advice on how to comply with those regulations. Learn more. Preview here. Purchase through FDLI's Web site. Purchase by using FDLI's fax order form.
Are you a new law firm associate, regulatory affairs manager or Capitol Hill staffer who needs a good overview of food and drug law and regulation? Register for "Fundamentals of Food and Drug Law" at early-bird rates!
FDLI SmartBrief | Oct 27, 2008
By attending this program, Dec. 2 and 3, you will learn the fundamentals of the laws and regulations that affect all FDA-regulated products: foods, drugs, biologics, medical devices and radiological health, veterinary products, dietary supplements, and cosmetics. International issues, the jurisdiction of other government agencies, and details specific to developing, processing, labeling, distributing and competitively marketing various FDA-regulated products will also be addressed. This course is designed to provide you with an overall landscape of food and drug law and how the FDA Amendments Act of 2007 is impacting the industries. CLE credits available pending state approvals. Learn more. Register online. Register by fax.
Are you new to food and drug law and regulation? Register today for "Fundamentals of Food and Drug Law" at early-bird rates!
FDLI SmartBrief | Oct 24, 2008
By attending this program, Dec. 2 and 3, you will learn the fundamentals of the laws and regulations that affect all FDA-regulated products: foods, drugs, biologics, medical devices and radiological health, veterinary products, dietary supplements, and cosmetics. International issues, the jurisdiction of other government agencies, and details specific to developing, processing, labeling, distributing and competitively marketing various FDA-regulated products will also be addressed. This course is designed to provide you with an overall landscape of food and drug law and how the FDA Amendments Act of 2007 is impacting the industries. CLE credits available pending state approvals. Read more. Register online. Register by fax.
Learn how to work with DEA: The other drug regulatory agency. Register for "The Regulation of Controlled Substances and Diversion Control"
FDLI SmartBrief | Oct 24, 2008
This conference, Dec. 4 and 5, will explore current and emerging issues in the regulation of controlled substances. Sessions include federal, state and international scheduling processes, registration, Risk Management Plans, and investigations and enforcement actions, with an emphasis on the how the law and regulations, as well as how the DEA and FDA, seek to balance the need to ensure the availability of these medicines while reducing the risk of diversion and abuse. Learn more. Register online. Register by fax. Mark your calendar for FDLI's Dec. 4 Holiday Networking and Awards Reception! Become a sponsor!
Clinical trials reporting is expanding, as featured in SmartBrief Oct. 13. Register today for "Introduction to Drug Law and Regulation" to learn more
FDLI SmartBrief | Oct 23, 2008
From the definition of "drug" to the different regulatory schemes for over-the-counter and prescription drugs, this meeting, Nov. 20 and 21, walks through the major statutory provisions and regulations, including how the FDA Amendments Act of 2007 is impacting clinical trial reporting. This program can help you and your organization stay in compliance with FDA regulations and help minimize regulatory problems. It provides an overview of FDA and outlines the history of and details specific to drug regulation. Read the article in SmartBrief. CLE credits are approved. View the agenda and make your hotel sleeping room reservation. Register online. Register by fax.
Attention law school professors, bookstore managers, purchasing agents and librarians: Preview, purchase "A Practical Guide to Food and Drug Law and Regulation," 3rd Edition
FDLI SmartBrief | Oct 23, 2008
This significantly updated third edition, including incorporation of the Food and Drug Administration Amendments Act and other new laws passed since 2002, provides readers a practical explanation of food and drug law and regulations in simple, nontechnical terms. This FDLI best-seller includes three new chapters: Combination Products, Pharmacovigilance and Regulation of Medical Research. "A Practical Guide" remains the single best resource for anyone needing a basic, uncomplicated understanding of the myriad requirements enforced by FDA. Preview now! Purchase through FDLI's Web site. Purchase by using FDLI's fax order form.
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