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ORGANIZATIONS Association of the British Pharmaceutical Industry www.abpi.org.uk Association of Clinical Research Organizations http://www.acrohealth.org Association of Clinical Research Professionals http://www.acrpnet.org Biotechnology Industry Organization http://www.bio.org CDISC, Clinical Data Interchange Standards Consortium http://www.cdisc.org CISCRP, Center for Information & Study on Clinical Research Participation www.ciscrp.org Drug Information Association br>http://www.diahome.org HL7, Health Level 7 http://www.hl7.org Pharmaceutical Research and Manufacturers of America http://www.phrma.org Regulatory Affairs Professionals Society http://www.raps.org Society for Clinical Data Management www.scdm.org Society of Clinical Research Associates www.socra.org FDA SITES FDA Home Page www.fda.gov FDA Electronic Submissions Gateway http://www.fda.gov/esg FDA - European Union http://www.fda.gov/oia/EC_EMEA.htm FDAAA http://www.fda.gov/oc/initiatives/HR3580.pdf Current Guidances http://www.fda.gov/opacom/morechoices/industry/guidedc.htm The Center for Biologics Evaluation and Research (CBER) http://www.fda.gov/cber/guidelines.htm The Manual of Regulatory Standard Operating Procedures and Policies http://www.fda.gov/cber/regsopp/regsopp.htm The Center for Drug Evaluation and Research (CDER) http://www.fda.gov/cder/ Sign up for E-mail to the CDER web site http://www.fda.gov/cder/cdernew/listserv.html Questions and Answers on Current Good Manufacturing Practices (cGMPs) for Drugs http://www.fda.gov/cder/guidance/cGMPs/default.htm The Data Standards Manual http://www.fda.gov/cder/dsm/index.htm Guidance documents specific to CDER http://www.fda.gov/cder/guidance/index.htm The CDER Handbook http://www.fda.gov/cder/handbook/index.htm CDER's regulatory guidance section http://www.fda.gov/cder/regulatory The Office of Regulatory Affairs (ORA) http://www.fda.gov/ora FDA and ORA site http://www.fda.gov/ora/compliance%5Fref The Compliance Policy Guide http://www.fda.gov/ora/compliance%5Fref/cpg Guide to Inspections http://www.fda.gov/ora/inspect_ref/igs/iglist.html The Guide to Inspection of Quality Systems http://www.fda.gov/ora/inspect_ref/igs/qsit/qsitguide.htm ADDITIONAL GOVERNMENT SITES Centers for Medicare & Medicaid Services http://www.cms.hhs.gov European Medicines Agency http://www.emea.europa.eu National Institutes of Health http://www.nih.gov Agency for Healthcare Research and Quality (AHRQ) http://www.ahrq.gov BLOGS ClinPage www.clinpage.com Drug and Device Law http://druganddevicelaw.blogspot.com EyeOnFDA http://www.eyeonfda.com In the Pipeline http://pipeline.corante.com The In Vivo Blog http://invivoblog.blogspot.com Pharmalot http://www.pharmalot.com Wall Street Journal's Health Blog http://blogs.wsj.com/health TOOLS Canada Trials http://canadatrials.com CenterWatch Clinical Trials Listing Service www.centerwatch.com Clinicaltrials.gov http://www.clinicaltrials.gov Drug Names Pronounced http://adr.org.uk/?page_id=93#C EDGAR; SEC Filings and Forms http://www.sec.gov/edgar.html The Federal Register http://www.gpoaccess.gov/fr/index.html PhRMA Clinical Study Results Database www.clinicalstudyresults.org WHO International Clinical Trials Registry Platform (ICTRP) www.who.int/ictrp/en |