FDA FDA Releases Two Draft Guidance Documents on REMS Thomas Sullivan Aug 23, 2018 0 In May 2018, the United States Food and Drug Administration (FDA) issued two draft guidance documents focused on developing a…
Congress The Year of the State Thomas Sullivan Aug 23, 2018 0 Following on the heels of more than 40 state legislatures, the U.S. Congress passed a federal right-to-try law giving patients…
FDA FDA Releases Draft Guidance on New MAT Opioid Use Disorder Treatments Thomas Sullivan Aug 22, 2018 0 On August 6, 2018, the United States Food and Drug Administration (FDA) released draft guidance, Opioid Use Disorder: Endpoints…
Telemedicine The Expected Impact of Telemedicine on the Elderly Thomas Sullivan Aug 21, 2018 0 As telemedicine continues to grow, it is likely to have impacts in all facets of the healthcare industry. BDO USA, LLP recently…
Life Science Compliance Update State Laws Have Teeth Thomas Sullivan Aug 21, 2018 0 In 1993, Minnesota became the first state to limit gifts and compensation provided by life science companies to healthcare…
BioSimilar Biosimilars Rapidly Gain Market Share in EU Thomas Sullivan Aug 20, 2018 0 As reported by Regulatory Focus, Biosimilar experts from across the EU continue to show how rapidly biosimilars have gained market…
DOJ AngioDynamics Settles False Claims Act Allegations for $12.5 Million Thomas Sullivan Aug 17, 2018 0 In July 2018, medical device manufacturer AngioDynamics, Inc., agreed to pay the United States $12.5 million to resolve…
AMA Doctors Do Their Part in the Battle Against Opioids Thomas Sullivan Aug 16, 2018 0 In a report released by the American Medical Association (AMA) , it was found that nationwide, more than 19 million fewer…
Life Science Compliance Update Swarming on the Opioid Crisis (Part 2) Thomas Sullivan Aug 16, 2018 0 This is the second article in the series exploring the major themes emerging from recent efforts to combat the ‘opioid crisis’ and…
Medical Legal Humana Faces Anti-Kickback and False Claims Act Suit Thomas Sullivan Aug 15, 2018 0 A federal judge recently denied motions by Humana Inc., in an ongoing whistleblower lawsuit with Hoffman-LaRoche Ltd. The lawsuit…