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Clinical and Scientific Data Analysis Consultants
to the Bio-Pharmaceutical Industry



Interesting Links
The SAS Institute
Pharmaceutical and Biotechnology News and Information
Bay Area SAS Users Group (BASAS)
The American Statistical Association
Drug Information Association
Biotechnology Industry Organization
SAS Links

REGULATORY
European Commission - Medical Devices
European Medicines Agency
FDA - CDER Guidance Document List
FDA - CDER News

FDA - CDER Guidance Document List
FDA - Center for Biologics Evaluation and Research
FDA - Center for Devices and Radiological Health
FDA - Center for Drug Evaluation and Research
FDA - Device Advice
FDA - Drug Approval Reports
FDA - Office of Combination Products
FDA - CDRH Electronic Copies and Electronic Submissions
FDA - CDRH Guidance Documents
FDA - CDRH International Issues
FDA - CDRH Medical Device Reporting
FDA - Medical Device Approvals
FDA - Recalls, Withdrawals and Alerts

FDA Approved Drug Products
FDA - MostRecent Recalls
FDA - Most Recent 483 Warning Letters

Health Canada - Medical Devices

Japan's (PMDA)

Medical Devices Agency (U.K.)

Medicines and Healthcare Regulatory Agency
Public Health Agency of Canada 

INFORMATION

21 CFR Part 11
Cafe Pharma
CenterWatch New Drug Approvals - browse by category

FOI Online

Medline Plus
New Drug Approvals - browse by category
PhRMA - New drugs in the pipeline 
Submitting an IND Application

RegSource
The Regulatory Consulting Network


INTERNATIONAL ORGANIZATIONS

Biotechnology Industry Organization (BIO) 

British Columbia Medical Device Industry Association (BCMeDIA)
Clinical Data Interchange Standards Consortium
Drug Information Association (DIA)
European Confederation of Medical Devices Organizations
European Diagnostic Manufacturers Association (EDMA)
European Medical Device Distributors Alliance
French National Association for Medical Technology Industries
Global Harmonization Task Force
International Association for Pharmaceutical Science and Technology (PDA)
International Biopharmaceutical Association
International Society for Pharmaceutical Engineering (ISPE)
Medical Devices Canada
Medical Devices in Scotland
Medical Industry Association of Australia (MIAA)

US NATIONAL ORGANIZATIONS
AdvaMed
American Association for Clinical Chemistry (AACC)
American Institute for Medical and Biological Engineering (AIMBE)
American National Standards Institute (ANSI)
American Society for Artificial Internal Organs
American Society for Quality (ASQ) - Biomedical Division
American Society for Testing and Materials (ASTM)
American Society of Mechanical Engineers
The American Statistical Association (ASA)
Association for the Advancement of Medical Instrumentation (AAMI)
Association of Clinical Research Professionals (ACRP) – Devices
Association of Medical Diagnostics Manufacturers (AMDM)
BIOCOM
Biomedical Engineering Alliance and Consortium (BEACON)
Biomedical Engineering Society (BMES)
Biomedical Marketing Association (BMA)
Biotechnology Industry Organization (BIO)
Cardiovascular Research Foundation
Combination Products Coalition
Controlled Release Society
Drug Information Association (DIA)
Engineering in Medicine and Biology Society (IEEE)
Health Industry Distributors Association
Healthcare Industries Association
Independent Medical Distributors Association (IMDA)
Joint Implant Surgery & Research Foundation
Medical Device Forum
Medical Device Manufacturers Association (MDMA)
Medical Marketing Association (MMA)
Medical Technology & Practice Patterns Institute
Medical Technology Leadership Forum
National Center for Biotechnology Information
Personalized Medicine Coalition
PhRMA - New drugs in the pipeline 
Pharmaceutical Business Intelligence & Research Group
Pharmamanufacturing Calendar of Events
Pharmaceutical Research and Manufacturers of America (PhRMA)
Product Development and Management Association (PDMA)
Radiological Society of North America
Regulatory Affairs Professional Society (RAPS)
Sino-American Pharmaceutical Professionals Association (SAPA)
Society For Biomaterials
Tissue Engineering and Regenerative Medicine International Society (TERMIS)
Tufts Center for the Study of Drug Development (CSDD)

US REGIONAL ORGANIZATIONS
Arizona BioIndustry Association (ABA)
BayBio (California)
BioDevice Group (California)
BioFlorida
BioGroup of Tech Collective, Rhode Island (BioGroup)
BioIndustry Organization of Southern Arizona (BIO-SA)
Bio Nebraska Life Sciences Association
Biotechnology Association of Alabama (BAA)
Biotechnology Association of Maine (BAM)
Biotechnology Council of New Jersey (BCNJ)
California Healthcare Institute
Center for Biotechnology (New York)
Colorado BioScience Association (CBSA)
Connecticut's BioScience Cluster
Edison BioTechnology Center, Ohio (EBTC)
Georgia Biomedical Partnership, Inc. (GBP)
Hawaii Science & Technology Council (HSTC)
Healthcare Institute of New Jersey
The Hollings Manufacturing Extension Partnership (MEP)
Idaho Bioscience Association (IBA)
Illinois Biotechnology Industry Organization (IBIO)
Indiana BioCrossraods
Indiana Health Industry Forum (IHIF)
Indiana Medical Device Manufacturers Council (IMDMC)
Kansas Bioscience Organization (KansasBio)
Life Sciences Greenhouse of Central Pennsylvania
LifeScience Alley, Minnesota
Long Island Life Sciences Initiative (LILSI)
Massachusetts Biotechnology Council (MBC)
Massachusetts Medical Device Industry Council (MASSMedic)
MichBio
Michigan Medical Device Manufacturers and Suppliers Association (MMD&SA)
Minnesota Biomedical Business Network
Missouri Biotechnology Association (MOBIO)
Montana Bioscience Alliance (MBA)
NanoBio Convergence (CA)
New England Healthcare Institute (NEHI)
New Mexico Biotechnology & Biomedical Association (NMBBA)
New York Biotechnology Association (NYBA)
NewJerseyLifeScience.com
New Jersey Technology Council
North Carolina Biosciences Organization (NCBIO)
North Carolina Medical Device Organization (NCMD)
OMERIS/Edison Biotechnology Center, Inc. (Ohio)
Orange County Biomedical Engineering Chapter of ASME (OC-BMEC)
Oregon Biosciences Association (OBA)
Palmetto Biotechnology Alliance, South Carolina
Pennsylvania Bio
Pittsburg Tissue Engineering Initiative (PTEI)
Puerto Rico Manufacturers Association
Stanford Biodesign Network, California
Southern California Biomedical Council Association
Technology Council of Maryland (TCM)
Tennessee Biotechnology Association (TBA)
Texas Healthcare and Bioscience Institute (THBI)
Utah Technology Council (UTC)
Virginia Biotechnology Association (VaBIO)
Washington Biotechnology and Biomedical Association (WBBA)
Wisconsin Biotechnology & Medical Device Association


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