Regulatory Outlook
Jul 01, 2010
Marcarelli Cooper Helfgott Cochran Eleanor Roosevelt once said: “Learn from the mistakes of others. You can’t live long enough to...
Jun 01, 2010
Regitz Dual disclosures to FDA and the U.S. Patent and Trademark Office (USPTO) that are not properly coordinated can sometimes have disastrous...
May 05, 2010
Shawn O'Dowd Advances in molecular diagnostics and genetic mapping are ushering in the era of personalized medicine. Although medicine has always...
Mar 01, 2010
   Numerof    Abrams    Rothenberg Viewed broadly, increasingly strict compliance requirements are part...
Feb 08, 2010
Zecchini Clinical laboratory tests account for more than $30 billion in annual expenditures in the United States, according to the Center for Medicare...
Jan 01, 2010
According to the European Commission, nearly 8000 types of products, ranging from simple bandages to diagnostic equipment to life-maintaining implantable...
Apr 22, 2009
Return to Article: Converting CAPA to an Advantage Medical Devices: Current Good Manufacturing Practice, 21 CFR 820 www.fda.gov/cdrh/fr1007ap.pdf...
Apr 22, 2009
Return to Article: Converting CAPA to an Advantage Top Five Device Observations Used in Turbo EIR* (FY 2007)   1. CAPA Activities/Documentation...
Nov 01, 2008
          Michael Marcarelli An FDA field investigator leaves your site after spending five days scrutinizing your...
Oct 01, 2006
  REGULATORY OUTLOOK     Building Quality into Device Clinical Trials, Part 2 When preparing a submission, organize the following...