Resources
The CCC Resource Center takes you to more than 50 resources in an easy-to-navigate Library, containing links to routinely updated information relevant to regulatory compliance, including regulations, policies, guidelines, publications, books, articles, presentations, and original content.
NOTE: The Resource Center is designed to supplement the training seminar, not be a substitute for it. “Test prep” materials for the Regulatory Compliance Test (RCT) can be found in the Test tab.
To access the resources in the CCC Center, just scroll down, or click any item below to go to the specific types of resources that interest you:
BOOKS & MANUALS
FDA Advertising and Promotion Manual (Must Be Purchased)
Edited by Wayne L. Pines and Coleen Klasmeier
Explains FDA and Federal Trade Commission (FTC) regulations and guidelines for advertising and promotion of: pharmaceuticals, medical devices, biologics, foods, veterinary medicines, and cosmetics. Regular newsletters, manual updates, and access to a subscriber-only Web site provide concise up-to-date coverage of fast-changing federal policies to help manufacturers of FDA-regulated products understand current advertising rules and avoid penalties for noncompliance.
Learn more Click here to learn more
FDA & ITS GUIDELINES
The links below have been selected because they provide healthcare communication professionals with critical information from the Food and Drug Administration (FDA).
FDA Sites
http://www.fda.gov
This is the FDA’s Home page, providing daily updated FDA news, Press Releases, and links to FDA information on drug approvals. At the bottom of the page you can sign up for any of the FDA email newsletters on topics such as biologics, medical devices, drugs, and recalls/safety alerts.
http://www.fda.gov/cder/warn/index.htm
This FDA site has copies of all Warning Letters and Notices of Violations (Untitled Letters) sent to Pharmaceutical Companies, listed chronologically by year; in some cases the Promotional Material to which the letter refers is also available.
http://www.fda.gov/cder/ddmac/
This is the site of the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC), the division of the FDA responsible for reviewing prescription drug advertising and promotional labeling.
http://www.fda.gov/cder/ddmac/lawsregs.htm
This site lists, and provides links to, all of the laws, regulations, guidances, and enforcement actions that fall under DDMAC’s responsibility.
http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr202_01.html
This site has the full text of the section of the Code of Federal Regulations (CFR Title 21, Part 202) dealing with Prescription Drug Advertising.
http://www.fda.gov/foi/warning.htm
This site provides an easy way to search the FDA’s database of Warning Letters by seven different categories, such as by date, or by company or subject of the Letter (grouped alphabetically). All Warning Letters and Responses are available in PDF format.
http://www.fda.gov/cber/efoi/adpromo.htm
This site, part of the FDA’s Center for Biologics Evaluation and Research (CBER), provides a chronological list of Violative Advertising and Promotional Labeling Letters for Approved Biological Products.
http://www.fda.gov/emaillist.html
Sign up here for free email updates from the FDA, which allows you to receive important FDA news and information as it becomes available.
OTHER RESOURCES
OIG (Office of the Inspector General of HHS)
This is the home page of the OIG of the Department of Health & Human Services, where you can read OIG news and sign up for email notifications, which include monthly information about new and expiring Corporate Integrity Agreements. OIG also has a What's New section that is updated frequently with news and announcements.
CIA Information Click here for detailed information about Corporate Integrity Agreements
ACCME (Accreditation Council for Continuing Medical Education)
The mission of the ACCME is identifying, developing, and promoting standards for quality continuing medical education (CME) utilized by physicians.
The following are links to ACCME policies and standards that apply to all CME providers
ACCME Standards for Commercial Support
ACCME Essential Areas and Their Elements
AMA (American Medical Association)
The AMA is the country’s largest physician group, advocating on issues vital to the nation’s health.
The following are links to AMA resources:
Continuing Medical Education section of AMA’s Web site
AMA’s Ethical guidelines for gifts to physicians from industry
AMA’s Guidelines for Corporate Relationships
AMA’s Ethical opinions and guidelines
INDUSTRY GROUPS & THEIR GUIDELINES
The links below provide healthcare communication professionals with information from other industry sources.
PhRMA (Pharmaceutical Research and Manufacturers of America)
PhRMA represents the country’s leading pharmaceutical research and biotechnology companies. Its declared mission is winning advocacy for public policies that encourage the discovery of life-saving and life-enhancing new medicines for patients by pharmaceutical/biotechnology research companies.
PhRMA Principles and Guidelines
PhRMA Code on Interactions with Healthcare Professionals (Note: The PhRMA Code was updated and enhanced as of 7/1/08 and takes effect on 1/1/09.)
PhRMA Principles on Clinical Trials
PhRMA Principles and Guidelines on DTC Advertising
PhRMA’s e-newsletter
PhRMA's e-newsletter, The RxMinute, keeps patients, care-givers, and doctors up-to-date on recently published studies.
Publications and studies of Innovation.org
A PhRMA project on new developments in pharmaceutical research.
Advanced Medical Technology Association (AdvaMed)
AdvaMed’s member companies produce nearly 90% of the healthcare technology purchased annually in the US, and more than 50% around the world; this technology includes medical devices, diagnostic products, and health information systems. AdvaMed advocates for a legal, regulatory, and economic climate that advances global healthcare by assuring patients have access to the benefits of medical technology.
AdvaMed’s Code of Ethics and related AdvaMed materials
AdvaMed’s Code of Ethics on Interaction with Health Care Professionals
Often called the “AdvaMed Code,” and includes Frequently Asked Questions about the Code.
AdvaMed’sSmartBrief
This is a free e-newsletter with daily summaries of the medical technology and diagnostics industry’s top news stories, around the globe.
Biotechnology Industry Organization (BIO)
BIO is the world's largest biotechnology organization, providing advocacy, business development, and communication services for more than 1,150 members worldwide, the majority of whom are engaged in biomedical research. BIO’s mission is to serve as the champion of biotech and as advocate for its member organizations. Its corporate members range from entrepreneurial companies developing a first product to Fortune 100 multinationals. In addition, BIO represents state and regional biotech associations, service providers to the industry, and academic centers.
BIO’s responses on regulatory matters
Biotechnology industry reports
NOTE: Biotech products are subject to the exact same regulations as pharma products.
PROFESSIONAL ORGANIZATIONS
The links below provide healthcare communication professionals with information from professional groups in the industry.
Food and Drug Law Institute (FDLI)
The FDLI is a nonprofit organization committed to providing education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy, and regulatory communities; the FDLI does not engage in advocacy activities. Information is available on their Web site about their conferences and workshops, as well as their publications, which include the quarterly peer-reviewed Food and Drug Law Journal and the bimonthly magazine Update. FDLI also publishes annually an FDA Directory which provides detailed e-mail, fax, and telephone information on all FDA employees and divisions.
Drug Information Association (DIA)
The DIA is a professional association whose 18,000 members worldwide are involved in the discovery, development, regulation, surveillance, or marketing of pharmaceuticals or related products. A financially independent nonprofit organization, DIA serves as a multidisciplinary, neutral forum for sharing information to optimize the process of drug development and lifecycle management, with continuously improved professional practice as its goal. Information is available on their Web site about DIA annual meetings, training courses, and publications, such as their quarterly peer-reviewed journal for members, Drug Information Journal.
Regulatory Affairs Professionals Association (RAPS)
RAPS is a worldwide member organization devoted to the health product regulatory profession. With more than 11,000 members from industry, government, research, clinical, and academic organizations in over 50 countries, and operating outside the political arena, RAPS provides a neutral forum on emerging science and global regulatory challenges. Information is available on their Web site about their conferences, training courses, and career development tools. RAPS in the News is a section of the RAPS Web site that posts health and regulatory news stories on a weekly basis. RAPS also publishes the members-only magazine, Regulatory Focus.