Search Results for: eric nielson

Editors: Charles J. Raubicheck Andrew S. Wasson Authors: Caroline Bercier Laura A. Chubb Leann M. Clymer Benjamin I, Dach, Ph.D. Laura Fanelli Russell A. Garman, Ph.D. Christopher Gosselin Blaine Hackman, Ph.D. Michael W. Harkness Jason A, Kanter Richard F. Kurz Erin A. Lawrence Alyse P. Mauro1 Rachael P. McClure Kate Mead3 Elizabeth Murphy Eric Nielson3 […]

FLH Partner Brian J. Malkin’s Chapter, “Free Speech and Off-Label Drug Promotion: Should Recent Cases Change Your Business Practices?” is now available as part of an Aspatore Special Report, Navigating Recent Off-Label Promotion Developments: Understanding Government Regulations and the Potential Impact of Noteworthy Cases published on September 1, 2013. FLH and FDA Lawyers Blog bring […]

Starting today, the reporting of all gifts or payments to physicians or teaching hospitals that total over $100 in a year will be required for drug and medical device companies per the new reporting requirements for the Affordable Care Act. These donations will be posted on a publically-accessible, Centers for Medicare and Medicaid Services (“CMS”) […]

Compounding pharmacies have been on FDA’s priority list since the 61 deaths and 749 cases of fungal infections from steroid injections contaminated during manufacture by New England Compounding Center (“NECC”), last fall. When appearing before Congress last November, FDA Commissioner Margaret A. Hamburg, M.D. plead a lack of regulatory authority in the wake of the […]

On June 4, FDA announced in the Federal Register that they were considering release of de-identified data sets in an effort to provide greater access to clinical and preclinical study data for researchers. This collaboration with the National Institutes of Health (“NIH”) would presumably work like other public databases NIH has supported over the years […]