Daniel A. Kracov

FDA Proposes a Restrictive Framework for Contacts Regulating Requests for Medical Product Information
Mahnu V. Davar,Jeffrey L. Handwerker,Daniel A. Kracov,Marissa Styne, January 19, 2012
On December 30, 2011, the US Food and Drug Administration (FDA) released for public comment a draft guidance titled, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” (Draft Guidance).1 The Draft Guidance provides FDA’s...

Potential Changes to US Federal Common Rule May Have Important Implications for Health Information Management In Clinical Trials
Mahnu V. Davar,Daniel A. Kracov,Nancy L. Perkins, September 12, 2011
On July 26, 2011, the US Department of Health and Human Services (HHS) announced its intention to modify current regulations (the “Common Rule”) governing human research subject protections. The advanced notice of proposed rulemaking (ANPR) poses several possible changes to the Common...

The Institute of Medicine Report on the FDA 510(k) Device Clearance Process: Dead on Arrival or Foundation for a New Regulatory Framework?
Daniel A. Kracov,Vernessa T. Pollard,Alex Toy, August 11, 2011
In light of questions regarding the ability of the 510(k) process to protect patients, and complaints that the process has become too burdensome and time-consuming, the US Food and Drug Administration (FDA) commissioned the Institute of Medicine (IOM) to conduct an extensive evaluation of the...