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ORGANIZATIONS Pharmaceutical Research and Manufacturers of America
PhRMA’s Web site includes policy documents, research reports, surveys, and a searchable database of drugs in development. Biotechnology Industry Oganization
BIO’s site offers industry fact sheets and timelines, policy statements and data on current industry issues, event calendar. Drug Information Association
The DIA home site is mostly for members, but does include listings of educational events (including e-courses) and a searchable directory of contract service organizations. Accrediting Council for Continuing Medical Education
A useful collection of standards documents plus directories of recognized state medical societies and accredited providers of continuing medical education Kaiser Family Foundation
A useful source of news and analysis on health policy, including a searchable database of opinion surveys on healthcare topics. Association of Clinical Research Professionals
Mostly members-only but a wide variety of reports and publications can be accessed Association of the British Pharmaceutical Industry
Statistics on the British pharmaceutical industry, plus guidelines, reports, press briefings, and position papers. Regulatory Affairs Professionals Society
Online educational programs, a bookstore, and selected articles on regulatory topics. FDA SITES The FDA home page is a deceptively simple door to a lot of information. Unless otherwise noted, nothing on the site is copyrighted -- neither text nor graphics. The public-domain material may be republished, reprinted, and used freely by anyone without obtaining permission from FDA. Electronic FOI reading rooms exist because of 1996 amendments to the Freedom of Information Act (FOIA) that mandated publicly accessible "electronic reading rooms," including electronic search and indexing capability. The FDA dockets management homepage is the official repository for the administrative proceedings and rule-making documents of the FDA. International Programs The FDA’s Office of International programs includes foreign language documents and information about the activities of the International Conference on Harmonization (ICH). The FDA Modernization Act of 1997 (FDAMA) has its own home page. Current Guidances The FDA comprehensive list of current guidance documents published by all the agency centers also provides links to other useful documents from the Office of the Commissioner, including a Small Business Guide to FDA that details procedures, policies, and regulations. The Center for Biologics Evaluation and Research (CBER) regulates vaccines, blood products, cellular & gene therapy, devises, tissues, and xenotransplantation. CBER's electronic FOI reading room provides information on approvals, enforcement actions, and product safety. Meeting minutes, speeches, and a handbook for making FOIA requests are also posted. The Manual of Regulatory Standard Operating Procedures and Policies is essential reading for compliance professionals. The Center for Drug Evaluation and Research (CDER) regulates therapeutical proteins and monoclonal antibodies (MAbs). The FDA oncology tools web site offers clinical regulations, contact information, and reference resources such as a list of approved oncology drugs. Sign up for E-mail Stay informed about changes and additions to the CDER web site by signing up for the daily or weekly email notices. Questions and Answers on Current Good Manufacturing Practices (cGMPs) for Drugs was begun in 2002 as part of the “CGMPs for the 21st Century Initiative. The Data Standards Manual is a compilation of standard nomenclature monographs that have been reviewed and approved by the CDER nomenclature standards committee. Guidance documents represent FDA's current thinking on a particular subject. Find all CDER guidances at this site. The CDER Handbook was developed to provide a user-friendly resource for information on processes and activities of interest to regulated industry, health professionals, academia, and the public. The handbook has an excellent acronym list. CDER's manual of policies and procedures can be keyword searched. CDER's regulatory guidance section provides a listing of regulatory and scientific guidances, specific regulatory initiatives, legislation, and compliance activities, including warning letters. The Office of Regulatory Affairs (ORA) lead office for all FDA field activities, offers inspection and compliance references along with contacts for industry assistance. FDA and ORA site provides links to documents, lists, policies, programs, and statements relating to compliance references used by FDA personnel. The Compliance Policy Guide site lists the compliance policy guide manual. Guide to Inspections. This guide to inspections provides separate resources for biotechnology, biologics, computer issues, devices, drugs, food, cosmetics, and others. The Guide to Inspection of Quality Systems details the inspectional process used to assess a medical device manufacturer's compliance with the quality system regulations. ADDITIONAL GOVERNMENT SITES Centers for Medicare & Medicaid Services
Regulations, news, speeches, testimony, and statistics on all aspects of Medicare and Medicaid, including data on national health expenditures, detailed information on the Prescription Drug Plan, and links to the national Health Outcomes Survey. European Medicines Agency
The site of the principal European drug agency includes data on approvals and withdrawals, policy statements, contact information, and more. National Institutes of Health
Extensive information on NIH programs and NIH-sponsored research, as well as convenient links to NIH’s 27 research centers and institutes. Agency for Healthcare Research and Quality (AHRQ)
News and research findings from the Nation's lead Federal agency for research on health care quality, costs, outcomes, and patient safety. BLOGS Pharmalot
Owned by the Newark Star-Ledger , Pharmalot provides continuously updated news and comment from veteran industry reporter Ed Silverman. Wall Street Journal’s Health Blog
Health and the business of health, with plenty of coverage of pharma, edited by longtime industry reporter Scott Hensley. Drugwonks
Vigorous analysis of the industry’s critics by Peter Pitts and Robert Goldberg of the Center for Medicine in the Public Interest. EyeOnFDA
Regulatory issues and more from Mark Senak of Fleishman Hillard. In the Pipeline
Insight into the thought processes of a pharmaceutical researcher from veteran pharma scientist Derek Lowe. The In Vivo Blog
Daily commentary on recent developments in biopharmaceutical business development, R&D, financing, marketing, and policy. Drug and Device Law
Insight on product liability from two top defense lawyers: James Beck of Dechert LLP and Mark Herrmann of Jones Day. The Orange Book Blog
“The Intersection of Patent and Food & Drug Law,” compiled by Aaron F. Barkoff of the law firm McDonnell Boehnen Hulbert & Berghoff LLP. Pharma Marketing Blog
Feisty reporting and opinions on marketing and advertising by John Mack, publisher of Pharma Marketing News. PharmaCentral
Continuously updated headlines from more than 30 pharmaceutical blogs and news sources. TOOLS Pharmaceutical Links and Resources
An enormous collection of pharma-related links: associations, regulatory agencies, journals, databases, schools of pharmacy, and much more. Clinicaltrials.gov
A searchable database of more than 47,000 clinical trials, from pre-recruitment to completed studies. Drug Names Pronounced
Just what it sounds like—and indispensable. Drug-Related Acronyms
An extensive collection of abbreviations compiled by the Food and Drug Law Institute. Medical Device Acronyms
Compiled by the Food and Drug Law Institute. EDGAR
A database of SEC filings by publicly held companies. The Federal Register
The official daily publication for rules, proposed rules, and notices of Federal agencies and organizations, as well as executive orders and other presidential documents. Online Mendelian Inheritance in Man
A searchable database of human genes and genetic disorders, hosted by the National Center for Biotechnology Information. Professional Services Directory
A searchable directory of consultants and lawyers specializing in drugs and medical devices, from the Food and Drug Law Institute. | 
