Daniel A. Kracov

Federal Appeals Court Affirms Imposition of Civil Money Penalties against Device Manufacturer and Individual Corporate Officer for Failure to File Medical Device Reports
Daniel A. Kracov, Arthur N. Levine, Jennifer Newberger, Vernessa T. Pollard, November 5, 2009
In TMJ Implants, Inc. v. United States Department of Health & Human Services, the United States Court of Appeals for the Tenth Circuit addressed the standards for liability for civil monetary penalties (CMPs) for the failure to file medical device reports (MDRs), and affirmed the US Food and...

Latest FDA Draft Guidance Affirms Continued Government Scrutiny of Risk Information in Prescription Drug and Medical Device Advertising
Daniel A. Kracov, Jeffrey L. Handwerker, Robert N. Weiner, Vernessa T. Pollard, Mahnu V. Davar, June 29, 2009
On May 26, 2009, the US Food and Drug Administration (FDA or Agency) released for public comment a Draft Guidance titled, "Presenting Risk Information in Prescription Drug and Medical Device Promotion" (Draft Guidance). www.arnoldporter.com

Vermont Passes Physician Gift Ban and Disclosure Law
Keith M. Korenchuk, Jeffrey L. Handwerker, Daniel A. Kracov, Robert N. Weiner, Tracey Glover, June 17, 2009
In the latest example of the proliferation of laws aimed at sales and marketing practices in the pharmaceutical and medical device industries, the Vermont state legislature passed legislation (the Act) on May 11, 2009 that imposes a comprehensive gift ban and disclosure law prohibiting...