The U.S. Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) said that they will offer enforcement discretion for their respective final rules for electronic health records (EHRs), a nod to the COVID-19 pandemic.
A recent Senate hearing raised the question of whether privacy and confidentiality are at risk when software is installed in smart devices for disease surveillance purposes, but there may be no absolute guarantee of confidentiality, jeopardizing the goodwill of citizens who are wary of big government.
The push in Congress to drive down U.S. prescription drug costs has taken a backseat to all things COVID-19, but that reprieve for drug companies may be about to end as freshman members of the House urge their leaders to include drug pricing proposals in the next coronavirus relief bill.
Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus.
LONDON - The director general of the World Health Organization has given a dignified and measured response to President Donald Trump’s decision to halt U.S. funding of WHO, pending a review of its handling of the coronavirus pandemic.
The age of molecular testing for the COVID-19 pandemic is still with us, but the emphasis in the months ahead will be on serological testing as a quicker, more useful mass testing alternative. However, test developers have a number of hurdles to overcome in devising these serological tests, including that antibodies for the virus’s antigens emerge at different times in the disease cycle, just one of several challenges that have to be met in the effort to bring the SARS-CoV-2 virus to heel.
One simple four-letter word can make a world of difference in how quickly biosimilars and interchangeables bring full competition to the U.S. marketplace of biologics, a handful of companies and industry groups told the FDA in comments on a draft guidance concerning the labeling of follow-ons that are licensed for fewer indications than the reference biologic.
There will be lessons learned aplenty when the COVID-19 pandemic finally breaks, including how serological and molecular testing can be used to maximum effect to corral a future pandemic. Carmen Wiley, president of the American Association of Clinical Chemistry, told BioWorld that the existing instrument types are up to the job, but that surge capacity is needed, and that it is not clear how the cost of that capacity will be handled.
As the demand increases for ventilators to treat Americans with severe symptoms of COVID-19, another shortage is being exacerbated – a shortage of the drugs needed to treat patients on ventilators.
Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be.
RSS
