Resources - Applied Clinical Trials

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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

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