geocities.com/techresources2000/pharmaceutical_links
This is an excellent Pharmaceutical Links page.

biotech.about.com/industry/biotech
This link offers the “About” list of “Biotechnology Industry, News, Links, and Information.”

http://www.21cfrpart11.com/
This extensive site, sponsored by NuGenesis Technologies, provides access to information on the Part 11 rule on "Electronic Records; Electronic Signatures." Discussions with industry peers and government regulators, articles, papers, and presentations can help you understand the impact of 21 CFR Part 11 on your GMP environment.

http://www.biofind.com/rumor
“The Biotech Rumor Mill: Rumors, Reports, and Reactions” Biofind site also lists biotechnology jobs, calendar events, chat rooms, news releases, and industry innovations.

http://www.cgmp.com/
“Current Good Manufacturing Practices” is a web site devoted to the current GMPs for the drug, medical device, and food industries. The site is maintained by Learning Plus, a provider of GMP training and training resources.

http://www.fdainfo.com/
This site from the publishers Washington Information Source, provides regulatory news and FDA documents. It covers GMP, validation, and inspection issues and offers the Validation Times and the Warning Letter Bulletin.

http://www.gmpseminars.com/
PharmaNet, Inc., offers a reprint service for FDA documents and training in GMP compliance, auditing, FDA inspections, and validation.

http://www.gmptraining.com/
This site has a directory of web sites and information related to GMP training.

http://www.i2icorp.com/
I2I Corporation’s Laureen Little is an editorial advisory board member for BioPharm. The site features a compliance “tip of the week” and the BioQuality newsletter, which focuses exclusively on quality, regulatory, and technical issues for biopharmaceuticals.

http://www.immel.com/
Barbara Immel writes a column in BioPharm called “GMP Issues,” which is offered on this web site along with her regulatory compliance, quality assurance, and training services in GCP, GLP, and GMP for the pharmaceutical, biotechnology, medical device, and active pharmaceutical ingredient industries.

http://www.medmarket.com/regulatory.cfm
The “Regulatory Affairs” window of medmarket offers a newsletter; a job marketplace; numerous links to consultants, meetings, organizations, newsgroups, and email list services; and a “regulatory theater” of workshops in Real Player format.

http://www.ranallc.com/
Nancy J. Chew is BioPharm’s columnist for regulatory affairs. Her site includes Nancy’s News, a guide to the latest information on regulatory affairs.

http://www.thompson.com/libraries/fooddrug
The Thompson Publishing group site offers a searchable database of warning letters issued by FDA and a “Guide to Good Clinical Practice” offering step-by-step guidance to avoiding costly errors and speeding FDA approval.


Industry Organizations

http://www.%20nrc.ca/
The National Research Council is Canada's science and technology research organization.

http://www.aaps.org/
AAPS serves as an information resource for integrating those sciences related to discovery, design, analysis, development, production, quality control, safety, clinical evaluation, regulation, distribution, and the use of drugs and drug delivery systems.

http://www.absa.org/
The American Biological Safety Association promotes biosafety as a scientific discipline, and its online journal and quarterly newsletter include information on regulatory initiatives, hazard recognition, and risk communication.

http://www.amdm.org/
The Association of Medical Diagnostics Manufacturers (AMDM) serves as a resource for education and information on compliance issues among diagnostics manufacturers and as an interface between them and FDA.

http://www.asq.org/
The American Society for Quality (ASQ) offers certification programs for quality assurance and control professionals. The site offers standards, a news archive, a glossary, and links to many quality assurance programs and products.

http://www.bio.org/
BIO is a trade organization representing the biotechnology industry. The site contains current legislative and appropriations information, industry agendas, and commentary on proposed regulatory activities.

http://www.bioindustry.org/
The BioIndustry Association encourages and promotes the biotechnology sector in the United Kingdom. The site has quick links, news, publications, and patent lists.

http://www.cato.com/biotech
The World Wide Web Virtual Library, Biotechnology Directory contains more than 1,000 URLs to companies, research institutes, universities, sources of information, and other directories specific to biotechnology and pharmaceutical development.

http://www.diahome.org/
The Drug Information Association (DIA) provides a neutral global forum for the exchange and dissemination of information on the discovery, development, evaluation, and use of medicines and related health care technologies. The site has a translation dictionary for many technical terms and allows a keyword search of Drug Information Journal articles.

http://www.gmp-compliance.com/
Based in Germany, the European Compliance Academy (ECA) was founded 1 January 1999 to build a common platform for discussions on CGMP compliance topics between the pharmaceutical industry and regulatory authorities in the United States and the European Union. The CGMP discussion forums are heavily used, and the site offers links to journals, guidelines, and education courses and conferences for GMP professionals.

http://www.pda.org/
The Parenteral Drug Association (PDA), an international association for pharmaceutical science and technology, offers conferences, training courses, meetings, and a monthly journal for regulatory compliance professionals.

http://www.raps.org/
The Regulatory Affairs Professionals Society (RAPS) offers training programs and certifies regulatory affairs professionals. Its web site includes job postings, an online yellow pages, and information on certification, as well as electronic information tools to keep you abreast of changing regulations in the global health care industry.



FDA on the Web

http://www.fda.gov/
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.

http://www.fda.gov/cber
The Center for Biologics Evaluation and Research (CBER) is the single most important source of information for compliance professionals working in the biopharmaceutical industry.

http://www.fda.gov/cber/efoi.htm
CBER’s electronic FOI reading room provides information on approvals, enforcement actions, recalls, and error and accident reports. Meeting minutes, speeches, and a handbook for making FOIA requests are also posted.

http://www.fda.gov/cber/genadmin/teambio.htm
Team Biologics is a partnership between CBER and FDA’s Office of Regulatory Affairs (ORA) to address inspection and compliance issues for biologic products.

http://www.fda.gov/cber/publications.htm
Download portable document format (PDF) files of CBER guidelines, Points to Consider, and guidance documents for biologics and biotechnology products free of charge. An “Index” link (to www.fda.gov/cber/publications.htm/compliance) shows you where to find just those publications related to GMP and compliance.

http://www.fda.gov/cber/regsopp/regsopp.htm
The Manual of Regulatory Standard Operating Procedures and Policies is essential reading for compliance professionals.

http://www.fda.gov/cder
The Center for Drug Evaluation and Research (CDER) covers those biopharmaceuticals that are not classified as biologics.

http://www.fda.gov/cder/cancer
The FDA oncology tools web site offers clinical regulations, contact information, and reference resources.

http://www.fda.gov/cder/cdernew/listserv.html
Stay informed about changes and additions to the CDER web site by signing up for the daily or weekly email notices.

http://www.fda.gov/cder/dmpq/cgmpnotes.htm
Human Drug CGMP Notes is a periodic memo for FDApersonnel on CGMP issues in human-use pharmaceuticals.

http://www.fda.gov/cder/dsm/index.htm
The Data Standards Manual is a compilation of standard nomenclature monographs that have been reviewed and approved by the CDER nomenclature standards committee.

http://www.fda.gov/cder/guidance/index.htm
Guidance documents represent FDA’s current thinking on a particular subject. Find all CDER guidances at this site.

http://www.fda.gov/cder/guidance/pv.htm
The Guidelines on General Principles of Process Validation is the handbook for meeting CGMPs in process validation.

http://www.fda.gov/cder/handbook/index.htm
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.

http://www.fda.gov/cder/mapp
CDER’s manual of policies and procedures can be keyword searched.

http://www.fda.gov/cder/regulatory
CDER’s regulatory guidance section provides a listing of regulatory and scientific guidances, specific regulatory initiatives, legislation, and compliance activities that list disqualified and restricted clinical investigators, warning letters, and information on the establishment evaluation system (EES). The site also links to the new (15 May 2000) Drug Application Regulatory Compliance manual.

http://www.fda.gov/cdrh
The Center for Devices and Radiological Health (CDRH) has the task of providing reasonable assurances of the safety and effectiveness of medical devices and eliminating unnecessary human exposure to radiation emitted from electronic products.

http://www.fda.gov/cdrh/devadvice
CDRH maintains the “Device Advice” site. It provides information on medical device classification, establishment registration, quality system regulations, labeling, premarket approval, and postmarket surveillance.

http://www.fda.gov/cdrh/dsma/cgmphome.html
Download PDF files of free FDA guidelines for medical devices.

http://www.fda.gov/cdrh/ggpmain.html
The good guidance practice (GGP) database contains a current comprehensive list of all guidance documents prepared for CDRH staff, regulated industry, and the public.

http://www.fda.gov/foi/foia2.htm
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.

http://www.fda.gov/ohrms
The FDA dockets management homepage has administrative proceedings, rule-making documents, and public participation guidance. The site also allows direct online comments relating to “Biotechnology in the Year 2000 and Beyond” public meeting.

http://www.fda.gov/oia/homepage.htm
The international section includes foreign language documents and ICH information.

http://www.fda.gov/opacom/7modact.html
The FDA Modernization Act of 1997 (FDAMA) has its own home page.

http://www.fda.gov/opacom/morechoices/industry/guidedc.htm
The FDA comprehensive list of current guidance documents published by all the agency centers also provides a link to A Small Business Guide to FDA that details procedures, policies, and regulations.

http://www.fda.gov/ora
The Office of Regulatory Affairs (ORA), lead office for all FDA field activities, offers inspection and compliance references along with contacts for industry assistance.

http://www.fda.gov/ora/compliance_ref
This FDA and ORAsite provides links to documents, lists, policies, programs, and statements relating to compliance references used by FDA personnel. The www.fda.gov/ora/compliance_ref/cpg site lists the compliance policy guide manual.

http://www.fda.gov/ora/inspect_ref/igs/biotech.html
Studying the Biotechnology Inspection Guide Reference Materials and Training Aids — reference material for inspectors and other FDA personnel — should help prepare any facility for an inspection.

http://www.fda.gov/ora/inspect_ref/igs/iglist.html
This guide to inspections provides separate resources for biotechnology, biologics, computer issues, devices, drugs, food, cosmetics, and others.

http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm
The Guide to Inspection of Quality Systems details the new inspectional process used to assess a medical device manufacturer’s compliance with the quality system regulations.



Other Government Sites

forms.psc.gov/forms/FDA/fda.html
FDA forms are posted in PDF format on a site maintained by the Program Support Center of the Department of Health and Human Services.

http://www.access.gpo.gov/#info
GPO Access provides quick links to several helpful databases. Most notably, they include the Code of Federal Regulations, the public law database, the United States Code of laws, the Congressional Record, and the Federal Register online. The catalog of government publications is searchable by keyword, and congressional and senate publications, bills, meetings, and hearings are available.

http://www.dol.gov/dol/osbp/public/sbrefa/main.htm
The Regulatory Compliance Assistance site maintained by the Department of Labor’s office of small business programs is designed to assist small businesses in complying with rules, regulations, and laws enforced by the department.

http://www.epa.gov/opptintr/biotech
The EPA Toxic Substances Control Act Biotechnology Program site contains the microbial products and biotechnology rule and supporting documents.

http://www.nal.usda.gov/bic
The Biotechnology Information Resource of the USDA National Agricultural Library provides access to selected sources, services, and publications covering agricultural biotechnology and its regulations.

http://www.nih.gov/od/oba/index.htm
The Office of Biotechnology Activities of the National Institutes of Health monitors scientific progress in basic and clinical research involving recombinant DNA and human gene transfer. The site contains guidelines and other documents.

http://www.osha.gov/
The Occupational Safety and Health Administration (OSHA) provides training materials, consultation programs, assistance for small business, and regulatory compliance information.