FDACounsel.com -- Links

FDACounsel.com -- 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

SCIENTIFIC CONSULTING FIRMS

The Weinberg Group -- a preeminent scientific consulting firm for the Life Sciences
   http://www.weinberggroup.com


REGULATORY NEWS & INFORMATION SOURCES *FDANews.com -- publisher of* *Devices & Diagnostics Letter* *and* *Washington Drug Letter* -- *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

ZapConnect.com Medical Device Industry Portal

	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

*SDRAN* = San Diego Regulatory Affairs Network -- http://www.sdran.org

*SQA* = Society for Quality Assurance -- http://www.sqa.org