Resources

The CCC Resource Center takes you to valuable 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 Products 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:

 


KEY LAWS & CODES

21 CFR, Part 202

This is the portion of the FDA Regulations addressing Prescription Drug Advertising

Click here to view 21 CFR, Part 202


OIG Compliance Guidelines

The Office of Inspector General (OIG) of the Department of Health and Human Services published its guidelines in the Federal Register stating the fundamental principles of compliance programs for pharmaceutical manufacturers

Click here to view OIG Compliance Program Guidance for Pharmaceutical Manufacturers


OIG's Definition of a CIA

Corporate Integrity Agreements (CIAs) are detailed and restrictive agreements imposed by OIG when serious misconduct (e.g., fraudulent action) is discovered

Click here to view the OIG's definition of a CIA


OIG CIAs

Corporate Integrity Agreements (CIAs) are detailed and restrictive agreements imposed by OIG when serious misconduct (e.g., fraudulent action) is discovered

Click here to view the complete list of CIAs


PhRMA Code

PhRMA has published Guiding Principles on Direct to Consumer Advertisements About Prescription Medicines

Click here to view the PhRMA DTC Code


PhRMA Principles on Conduct of Clinical Trials

PhRMA has published Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results

Click here to view the PhRMA Principles on Conduct of Clinical Trials


ACCME Standards for Commercial Support

The Accreditation Council for Continuing Medical Education’s (ACCME) stated mission is identifying, developing, and promoting standards, which apply to all CME providers, for quality continuing medical education (CME) utilized by physicians

Click here to view the ACCMEStandards for Commercial Support


AdvaMed Code

The Advanced Medical Technology Association (AdvaMed) members are companies that produce healthcare technology, specifically medical devices, diagnostic products, and health information systems

Click here to view the AdvaMed Code of Ethics on Interactions with Health Care Professionals


AMA Guidelines

The American Medical Association (AMA) is the country's largest physician group, advocating on issues vital to the nation's health

Click here to view the AMA's "Code of Medical Ethics", which includes its "Opinions on Confidentiality, Advertising, and Communications Media Relations" (section 5.0)


DHC Guiding Principles and Best Practices for Social Media

The Digital Health Coalition (DHC) is a nonprofit organization created to serve as the collective public voice and national public forum for the discussion of the current and future issues relevant to digital and electronic marketing of healthcare products and services

Click here to view the DHC's Social Media Guiding Principles and Best Practices. Select Category "Social Media", then scroll down



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GOVERNMENT & INDUSTRY GROUPS

Food and Drug Administration (FDA)

The FDA regulates the advertising and promotion of prescription drugs, biologics, and medical devices in the U.S. FDA has authority over all product-specific promotional materials that are issued by, or on behalf of, companies. Its homepage provides daily updated FDA news, press releases, and links to FDA information on drug approvals.

Click here to view the FDA homepage


Office of the Inspector General of HHS (OIG)

The Office of the Inspector General (OIG) of the Department of Health & Human Services (HHS) oversees programs that prevent fraud and abuse in programs where the government buys or pays for prescription drugs and biologics, such as Medicare and Medicaid. On its homepage you can read OIG news and sign up for email notifications.

Click here to view the OIG homepage


AdvaMed

The Advanced Medical Technology Association (AdvaMed) members are companies that produce healthcare technology, specifically medical devices, diagnostic products, and health information systems

Click here to view the AdvaMed homepage


AMA

The American Medical Association (AMA) is the country's largest physician group, advocating on issues vital to the nation's health

Click here to view the AMA homepage


Biotechnology Industry Organization (BIO)

BIO is the world's largest biotechnology organization, providing advocacy, business development, and communication services for its members; BIO’s mission is to serve as the champion of biotech

Click here to view the BIO homepage


PhRMA

The Pharmaceutical Research and Manufacturers of America (PhRMA) represents research-based pharmaceutical and biotechnology companies

Click here to view the homepage


Coalition for Healthcare Communication (CHC)

CHC is an organization that promotes the free exchange of scientific and medical information. In addition to publishing white papers and other documents, the group offers relevant information on current healthcare and health economics issues, as well as policy positions published by government agencies and other professional organizations.

Click here to view the Coalition homepage

Click here to view Coalition news and commentary


Drug Information Association (DIA)

DIA is a neutral, nonprofit, global, professional association whose members work in every facet of the discovery, development, and life-cycle management of pharmaceuticals, medical devices, and related products

Click here to view DIA Conferences and Meetings


Food and Drug Law Institute (FDLI)

FDLI is a nonprofit organization that provides a marketplace for discussing food and drug law issues through conferences, publications, and member interaction

Click here to view FDLI Conferences


Regulatory Affairs Professionals (RAPS)

RAPS is a global membership organization of regulatory professionals in the rapidly-growing medical device, pharmaceutical, and biotechnology sectors

Click here to view the RAPS Meetings and Education Calendar



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FDA AT-A-GLANCE

FDA Approvals and Clearances

Click here to view Approved Drug Products

Click here to view Device Approvals and Clearances


FDA Guidances

FDA Guidance documents represent current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public.

Click here to view the list of FDA guidances

Click here to view Guidance on Good Reprint Practices

Click here to view Guidance on Industry-Supported Scientific and Educational Activities

Click here to view Guidance on Consumer-Directed Broadcast Advertisements

Click here to view Draft Guidance on "Help-Seeking" and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms

Click here to view Draft Guidance on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices

Click here to view Draft Guidance on Presenting Risk Information in Prescription Drug and Medical Device Promotion


FDA Office of Prescription Drug Promotion (OPPD)

Formerly known as DDMAC, this is the division of the FDA responsible for reviewing prescription drug advertising and promotional labeling. The site below lists and provides links to the laws, regulations, guidances, and enforcement actions that fall under OPDP's responsibility.

Click here to view OPDP Regulatory Information


FDA REMS

The Food and Drug Administration Amendments Act (FDAAA) of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks

Click here to view the Approved REMS


FDA Email Updates

FDA provides a variety of newsletters and updates by email

Click here to get FDA email updates


FDA Warning Letters – By Year

FDA uses Warning Letters to notify the regulated industry about violations documented during its inspections or investigations; the site below lists them chronologically by year

Click here to view the year-by-year list of FDA Warning Letters


FDA Warning Letters – Search Page

The FDA enables users to search its database of Warning Letters in a number of different ways, such as by date or company or subject of the Letter

Click here to view the search page for FDA Warning Letters



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NEWSLETTERS/MAGAZINES/BLOGS

Drug and Device Law is a blog representing the views of Jim Beck and other Dechert attorneys on topics related to pharmaceutical and medical device product liability litigation (click here)

DrugWonks.com, the blog of the Center for Medicine in the Public Interest (CMPI), is a forum offering rigorous and compelling research on the most critical issues affecting current drug policy. The blog is hosted by the founders of CPMI, Dr. Robert Goldberg and Peter Pitts, former FDA Associate Commissioner for External Relations. (click here) Twitter: @drugwonks

Eye on FDA addresses the approval and marketing of pharmaceutical drugs, particularly as related to their regulation by the FDA (click here) Twitter: @eyeonfda

FDA Law Blog represents the views of the law firm Hyman, Phelps & McNamara, P.C. (click here)

FDA Lawyers Blog represents the views of Frommer Lawrence & Haug's (FLH's) FDA/Regulatory Group (click here)

FDA Matters: The Grossman FDA Report provides insight, information and a fresh perspective about the FDA and its interactions with Congress, the media, and stakeholders (click here) Twitter: @fdamatters

FDAzilla provides stories from the front lines, perspectives on trends, interpretations of data, and synthesis of industry news related to the FDA (click here) Twitter: @fdazilla

FiercePharma is the industry's daily monitor, with a special focus on pharmaceutical company news (click here) and biotech news (click here) Twitter: @fdazilla

Fierce Medical Devices provides breaking news and critical insights into the medical device and diagnostics industries, with a special emphasis on clinical studies, FDA/EMEA regulations, and post-marketing (click here)

Medical Devices Today provides business strategy, regulatory, innovation, and investment news about the medical devices industry (click here)

PharmExecBlog provides discourse, dialogue, and discussion about global pharma matters (click here)

PharmaLive provides broad coverage of pharmaceutical business, product marketing, and clinical research (click here)

Pharmalot is a blog representing the views of Ed Silverman (click here)

Pharma Marketing News is an independent monthly electronic newsletter focused on issues of importance to pharmaceutical marketing executives (click here)

Pharma Marketing Blog is a blog representing the views of John Mack, the publisher and editor of Pharma Marketing News (click here)

Pharmaceutical Compliance Monitor spotlights regulatory and compliance news and developments for the pharmaceutical and biotechnology communities (click here) Twitter: @pharmacomplianc

Pharmaceutical Executive is designed to meet the diverse management and marketing needs of professionals in the pharmaceutical industry worldwide; editorial provides useful information on marketing, sales, and promotion, as well as legal and regulatory issues (click here)

PharmaVOICE magazine is the monthly executive forum that allows business leaders to engage in a candid dialogue on myriad challenges and trends that impact the life-sciences industry (click here) Twitter: @pharmavoice

Pharmaceutical Market Europe (PME) provides insight, commentary, and analysis on the issues that affect doing business in Europe, and offers innovative ways to address the ongoing challenges of the market (click here) Twitter: @pmlivecom

Rx Compliance Report, a biweekly newsletter, is the only news source exclusively devoted to the government's crackdown on pharmaceutical sales and marketing practices (click here)


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