COLLEAGUES and COLLABORATORS
Paul Flyer and Molly Fisher Pacific Northwest Statistical Consulting,
Inc.
www.pnwstat.com
Brent A. Blumenstein, PhD Trial Architecture Consulting
www.TriArcConsulting.com
David Boyden—commercialization strategy Mirador Strategies Inc
www.miradorstrategies.com
Larry Johnson –Regulatory strategy
www.biofinity.org
Adkins, Plant, Elvins & Black, PLLC--
Legal strategy and support
www.adkinsandplant.com
Northwest Biotechnology Consultants: directory of independent biotechnology
consultants
located in the Pacific Northwest.
www.nwbioconsultants.com
REGISTRAT®, Inc: Strategic
design and implementation of Late Phase Studies to optimize clinical
and commercial benefits to support product
launch and commercialization
http://www.registrat.com/
Aclairo: non-clinical toxicology and pharmacology; regulatory issues
http://www.aclairo.com
REGULATORY AGENCIES
United States
US Food and Drug Administration: www.fda.gov
US Code of Federal Regulations (CFRs): www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
Center for Drugs Evaluation and Research: www.fda.gov/cder
Center for Drugs Evaluation and Research, Available Guidance Documents:
www.fda.gov/cder/guidance/index.htm
Center for Biologics Evaluation and Research: www.fda.gov/cber
Center for Biologics Evaluation and Research, Available Guidance
Documents: www.fda.gov/cber/reading.htm
FDA Drug Advisory Committees, rosters, meetings and documents:
http://www.fda.gov/oc/advisory/acdrugs.html
Disclosable FDA Warning Letters: www.fda.gov/foi/warning.htm
FOI Services, Inc. (provision of FDA documents under Freedom of
Information Act, fee): www.foiservices.com
Australia:
Therapeutic Goods Administration: www.tga.gov.au
Canada:
Health Canada: http://www.hc-sc.gc.ca/dhp-mps/index_e.html
Europe:
European Medicines Evaluation Agency (EMEA): www.emea.eu.int
ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use): www.ich.org
World:
World Health Organization: www.who.int/en
Pharmaceutical Industry Resources:
Washington Biotechnology and Biomedical Association: www.wabio.com
Biotechnology
Industry Organization: www.bio.org
International Federation of Pharmaceutical Manufacturers and Associations
(IFPMA): www.ifpma.org
Pharmaceutical Research and Manufacturers Association of America
(PhRMA): www.phrma.org
Biospace: Biotech and Pharmaceutical News & Jobs - http://www.biospace.com
Pharmacopoeias:US Pharmacopoeia (USP)/National Formulary (NF): www.usp.org/USPNF
CLINICAL TRIALS
ClinicalTrials.gov is a registry of federally and privately supported clinical trials - http://www.clinicaltrials.gov
National Cancer Institute clinical trials: http://www.cancer.gov/clinicaltrials
MEDICAL LITERATURE
Pub Med: http://www.ncbi.nlm.nih.gov/sites/entrez