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GOVERNMENT SOURCES
OTHER REGULATORY RESOURCES
PROFESSIONAL ORGANIZATIONS
QUALITY AND RELATED ISSUES
INDUSTRY - DOCUMENTS AND OTHER INFORMATION
INDUSTRY - BIOLOGICS
INDUSTRY - PHARMACEUTICALS
INDUSTRY - DEVICES & DIAGNOSTICS
EMPLOYMENT
GOVERNMENT SOURCES
- FDA Home Page: Links to all FDA Offices and the Bulletin Board.
- FDA CBER: Describes recent biological approvals and links to CBER's document database.
- FDA CDER: Describes new drug approvals for 1994 and the NDA review process. Links to CDER's gopher, which provides access to a variety of directories, including Policies and Procedures, DMFs, Human Drug CGMP Notes, Approved Drug Products, and FDA phone/fax numbers.
- FDA Bulletin Board System (BBS)
Documents can also be obtained from FDA via the Facts-on-Demand system by calling 1-800-342-2722 for CDER, 1-800-835-4709 for CBER, or 1-800-899-0381 for CDRH documents from a touch-tone phone. Up to 3 guidance documents will be sent per phone call. All 3 divisions will also fax a listing of available documents upon request. The system takes both domestic and international calls.
- GPO Access: The Government Printing Office Home Page with access to the 1995 and 1996 Federal Register, including very thorough search mechanisms. Documents are retrievable as a summary, text file, or PDF file for those with Acrobat readers.
- Purdue University GPO Access: Purdue's Law Library also offers free access to GPO documents. The search mechanism is very friendly.
- National Institutes of Health Home Page: Access to e-mails for NIH personnel and links to the Office of Technology Transfer. Also offers a listing of NIH scientific resources, including NIH laboratories on the Web.
- NIH Pointer to On-line Journals : Links to the Journal of Molecular Biology, Cell, Immunity, Nature, etc.
- NIH Report on Gene Therapy: Report and Recommendations of the Panel to Assess the NIH Investment in Research on Gene Therapy
- National Center for Biotechnology Information (NCBI)
: Includes gene bank submissions on the World Wide Web and GenBank (NIH genetic sequence database)
- Center for Disease Control (CDC) Web Server: Offers a Prevention Guidelines database with a good search engine (by topic, title, date or keywords). Also lists funding opportunities at CDC, and the Weekly Morbidity and Mortality Report.
- US Department of Health and Human Services
OTHER REGULATORY RESOURCES
- The Regulatory Affairs Home Page: Comprehensive and well-organized clearinghouse of regulatory affairs resources. Includes links to FDA, consultants and trade organizations, the Federal Register, the U.S. Code, and more. Also offers a great guide to FDA sites via an Agency Matrix, including home pages to all FDA Offices, press releases, directories and guidelines.
- RegSource.com: A free site providing an efficient and intuitive way to access global regulatory information with a focus on the FDA. Links to over 1,400 sites and provides the Federal Register notices indexed by subject.
- The Regulatory Forum BBS: An extension of the Regulatory Affairs Home Page. Dial-up access only (919-848-9461). Currently uses 14,400 modem. Maintains over 500 files of FDA regulatory information and message areas for communication with other RA professionals.
- North Carolina Regulatory Affairs Forum: A local forum for exchanging information about regulatory affairs activities. Membership offers opportunities to network with participating organizations and attend educational meetings.
PROFESSIONAL ORGANIZATIONS
- Regulatory Affairs Professional Society (RAPS) Home Page: Information on membership, upcoming conferences and workshops, and taking the Regulatory Affairs Certification (RAC) examination.
- The Food and Drug Law Institute (FDLI) Home Page: Has a link to Hot Documents which currently offers FDA's new MDR Reporting Final Rule (also available here on the Regulatory Forum), and Dr. Kessler's and Congressman Bliley's remarks at FDLI's 39th Annual Educational Conference. Also presents membership info, listings of seminars/conferences, and publications for sale.
- BIO Online: The Biotechnology Industry Organization is currently offering R&D facility standards (minimum acceptable and ideal specifications).
- AAPS Home Page: The American Association of Pharmaceutical Scientists
- USP Home Page
- USP Microbiology Home Page: Lists proposed revisions in the Pharmacopeial Forum to referee microbiological tests. Currently seeking feeback on the issue of incubation time for Sterility Testing. Comments can be sent directly from the Home Page.
- Micro BBS Web Page: Offers extensive file libraries of biologic and healthcare information, including Microbiology, Infectious Diseases, General Biology, Biochemistry, Biostatistics, Laboratory Productivity, and Regulatory Issues in Biology. NOTE: The Web Page lists available files, but access is through dial-up at 1-817-557-0330.
SOFTWARE SYSTEMS AND RELATED SERVICES
- Life Cycle Solutions, Inc.
: LCS is a world-recognized PDM consulting firm dedicated to helping organizations and vendors understand and leverage the benefits of PDM solutions. LCS specializes in product data management and work flow solutions, product life cycle analysis, multi-media applications, standards compliance and legacy system integration, and authored the PDM System Evaluation and PDM Cost Justification Toolkits. LCS also is joint-owner of the PDM Information Company, which sponsors the Worldwide Web-based PDM Information Center, available from LCS' URL.
QUALITY AND RELATED ISSUES
INDUSTRY - DOCUMENTS AND OTHER INFORMATION
- IDRAC:
Pharmaceutical Regulatory Affairs database offering information both on CD-ROM and on-line, including
legal and administrative affairs and quality, safety and efficacy regulations for Europe and the United
States. IDRAC gives clear, step-by-step instructions to help you navigate the drug application process.
- IHS Health Information: IHS® Health Information offers
Pharmaceutical and Medical Device Manufacturing regulations and standards -- compiled and accessible on CD-ROM or via the IHS Health Website.
INDUSTRY - BIOLOGICS
INDUSTRY - PHARMACEUTICALS
- PharmInfo Net: A storehouse of information relevant to the pharmaceutical industry
- Pharmatech's Home Page: Access to clinical trial information, opportunities for patient volunteers
- Eli Lilly & Co.: Company information only
- Ciba's Home Page: Company information and links to other sites
- Millipore: Information on filtration and water purification products, case studies, technical support
- Corning Besselaar: Pharmaceutical and biotechnology development/clinical contract research and development
INDUSTRY - DEVICES & DIAGNOSTICS
EMPLOYMENT
- Medzilla: A great place to advertise jobs ... and find outstanding candidates. Developed and sponsored by the Franklin Search Group, probably the first and certainly one of the most-respected executive search firms on the World Wide Web.
- Caliber Associates: A retained executive search firm specializing in the life sciences.
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