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Resources
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Pharmaceutical Industry Organizations Medical Device Industry Organizations International Regulatory / Advisory Sites Miscellaneous New Drug, Biologics or Device Sites Pharmaceutical Industry Organizations http://www.aapspharmaceutica.com/ American Association of Pharmaceutical Scientists (AAPS)
Consumer Healthcare Products Association (CHPA)
Generic Pharmaceutical Association (GphA)
Parenteral Drug Association (PDA)
Pharmaceutical Research and Manufacturers of America (PhRMA)
Drug Information Association
International Society for Pharmaceutical Engineering
International Pharmaceutical Excipients Council of the Americas
Food and Drug Law Institute
Product Quality Research Institute
Pharmweb - pharmaceutical web
Biotechnology Industry Organization (BIO)
Medical Device Industry Organizations Regsource
Medical Devicelink
Association for the Advancement of Medical Instrumentation (AAMI)
Health Industry Manufacturers Association (HIMA)
Medical Device Manufacturers Association (MDMA)
Massachusetts Medical Device Industry Council (MassMEDIC)
Regulatory Affairs Information Homepage-
U.S. Food and Drug Administration
U.S. FDA, Center for Drug Evaluation and Research
U.S. FDA, Center for Biologics Evaluation and Research
U.S. FDA, Center for Devices and Radiological Heath
http://www.access.gpo.gov/ecfr/ U.S. Government Printing Office, Electronic Code of Federal Regulations
http://www.access.gpo.gov/su_docs/regulatory.html Regulatory resourses on the Government Printing Office Access site
U.S. Federal documents open for comment and published in the Federal Register, the Government’s legal newspaper
Association of Clinical Research Professionals (ACRP)
International Regulatory / Advisory Sites
World Health Organization
Miscellaneous New Drug, Biologics or Device Sites
Tufts Center for Drug Development/Tufts University
Search the Federal Register http://www.gpoaccess.gov/fr/index.html
Regulatory Affairs for the Non-regulatory Medical Device Professional Presentation formats: (Powerpoint) (Acrobat PDF)
Powerpoint format Portable Document format
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