Links & Abbreviations
GOVERNMENT

FDA -- http://www.fda.gov

Center for Biologics Evaluation & Research (CBER) -- http://www.fda.gov/cber

Center for Drug Evaluation & Research (CDER) --http://www.fda.gov/cder

Center for Devices & Radiological Health (CDRH) --
http://www.fda.gov/cdrh

Center for Food Safety & Applied Nutrition (CFSAN) --   
http://www.cfsan.fda.gov/list.html

Office of Regulatory Affairs (ORA) -- http://www.fda.gov/ora

HHS -- http://www.hhs.gov

Office of Human Research Protection (OHRP) -- http://www.hhs.gov/ohrp/

Office of Civil Rights -- (OCR) [administers HIPAA rules]
http://www.hhs.gov/ocr/hipaa/
TRADE ASSOCIATIONS

Advanced Medical Technology Association -- (AdvaMed} -- http://www.advamed.org

Biotechnology Industry Association (BIO) -- http://www.bio.org

Consumer Healthcare Products Association (CHPA) -- http://www.chpa-info.org/     

Generic Pharmaceutical Association (GPhA) -- http://www.gphaonline.org

Medical Device Manufacturers Association (MDMA) -- http://www.medicaldevices.org

Pharmaceutical and Research Manufacturers of America (PhRMA) -- http://www.phrma.org   
REGULATORY NEWS & INFORMATION SOURCES

FDANews.com -- publisher of Devices & Diagnostics Letter and
Washington Drug Letter --  http://www.fdanews.com

FDC Reports -- publisher of the Pink and Gray Sheets --
http://www.fdcreports.com

FOI Services -- foremost supplier of FDA documents via FOI --  
http://www.foiservices.com

FDAWebview -- http://www.fdaweb.com/default.php?ea=subs
PROFESSIONAL WRITING LINKS

Hi-Way Haven -- a hub for writers, both creative and non-fiction
-- http://www.hi-way-haven.com.
PROFESSIONAL ORGANIZATIONS
ACRP = Association of Clinical Research Professionals --
http://www.acrpnet.org
DIA = Drug Information Association -- http://www.diahome.org
FDLI = Food & Drug Law Institute -- http://www.fdli.org
MAGI = Model Agreement Group Initiative -- coalition of research professionals dedicated
to improving the clinical research contracting process  -
http://www.firstclinical.com/magi/
OCRA = Orange County Regulatory Affairs Discussion Group --
http://www.ocra-dg.org
Pharmaceutical, Cosmetic & Nutraceutical Alliance -- http://www.pcnalliance.org
RAPS = Regulatory Affairs Professionals Society -- http://www.raps.org
SDBN = San Diego Biotechnology Network -- http://sdbn.org
SQA = Society for Quality Assurance -- http://www.sqa.org
SDRAN = San Diego Regulatory Affairs Network -- http://www.sdran.org
© 2014  Michael A. Swit.  
ALL RIGHTS RESERVED.

Questions?

Contact me @ 760-815-4762
or
mswit@fdacounsel.com
Michael A. Swit
Play Performances by my son, Rafael

Enemy of the People, February 2012