Alexandra PearsallOn June 21, the U.S. Food and Drug Administration (FDA) finalized industry guidance pertaining to the requirements and recommendations for manufacturers, packers, and distributors when…
The Food and Drug Administration (FDA) recently published a Notice and Request for Comments regarding a potential proposal to impose less stringent regulations on biopharmaceutical…
Day PitneyPatients are receiving opioids at a rate that is nearly four times what they actually use following surgery. A study published in JAMA Surgery on…
Physicians and Teaching Hospitals Received $8.4 Billion in Payments in 2017
On June 29, the Center for Medicare & Medicaid Services (CMS) published data summarizing payments made by drug and medical device companies to physicians and…
On June 12, the U.S. Food and Drug Administration (FDA) published two new guidance documents that address how companies can share off-label information with insurers…
Medical device and pharmaceutical recalls reached historic highs in the first quarter of 2018, according to a report from Stericyle Expert Solutions.More than 208 million…
FDA Plan Aims to Improve Cybersecurity of Medical Devices
The U.S. Food and Drug Administration (FDA) recently released a Medical Device Safety Action Plan detailing its current initiatives and future plans to ensure the safety…
Abiomed Reaches $3.1 Million Settlement for Doctor Meals
Abiomed, Inc. has agreed to pay $3.1 million to resolve allegations that the company treated physicians to lavish meals at some of the country’s most…
While manufacturers are generally responsible for initiating medical device recalls, providers are usually best positioned to identify and notify affected patients and quarantine identified devices.…
A January 29 article in Bloomberg BNA’s Health Care Daily Report, “Is Artificial Intelligence Ready for Health-Care Prime Time?,” discussed the potential impact of artificial…