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
SDRAN
=
San Diego Regulatory Affairs Network
--
http://www.sdran.org
SQA
=
Society for Quality Assurance
--
http://www.sqa.org
Law Offices of Michael A. Swit
© 2011 Law Offices of Michael A. Swit.
ALL RIGHTS RESERVED.
Questions?
Contact us @ 760-815-4762
or
mswit@fdacounsel.com
