On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Amendments).
Health Care partner Tom Jeffry, and 44 other health care executives, spoke to Becker’s Hospital Review about the key trends disrupting the traditional hospital and how institutions can prepare for the future. “Looking towards the future, hospitals will devote more space and technology to accommodate advances in diagnostics and surgical procedures. New technologies will continue to reduce inpatient admissions as well as the number of days inpatients remain in the hospital.
AnMed Health, a hospital located in South Carolina, recently agreed to pay almost $1.3 million dollars and enter into a settlement agreement with the HHS Office of Inspector General (OIG) to resolve allegations that it violated the Emergency Medical Treat
Last week, the FDA released a draft guidance titled Product Identifier Requirements Under the Drug Supply Chain Security Act--Compliance Policy, with a 60-day comment period ending around September 3, 2017.
With the federal response to the opioid crisis still under development, state and local governments continue to file lawsuits against the pharmaceutical companies that manufacturer these products, accusing them of misleading doctors and consumers about the risks of addiction.
On June 21, the Food and Drug Administration announced a Drug Competition Action Plan in order to attempt to address ways that the agency's rules have been, in the agency's view, “gamed” to create obstacles that delay generic drug approvals to reduce generic competition.
Earlier this year, ransomware known as Wannacry crippled Britain’s National Health Service and spread across the globe affecting many other organizations, large and small. Now, many organizations are grappling with a new onslaught caused by similar ransomware dubbed Petya.
In a move that practically all Medicare providers, suppliers, and Clinical Laboratory Improvement Amendments laboratories will welcome, the Centers for Medicare & Medicaid Services has declared that Plans of Correction and Allegations of Compliance no longer must be input directly onto the Statement of Deficiencies form (also known as “Form 2567”).
Nevada is the latest state in the Union to adopt some form of a drug pricing transparency law, after Nevada Governor Brian Sandoval signed Senate Bill No. 539 into law on June 15, 2017. The breadth and scope of this particular bill is unlike any other transparency bill that we have seen to date, and has the potential to impact not only the manufacturers of the narrow class of drugs the bill focuses on, but all manufacturers with sales forces in Nevada, as well as non-profit patient assistance programs.