The U.S. Food and Drug Administration (FDA) recently issued draft guidance on how it will continue to conduct remote regulatory assessments (RRAs) after the COVID-19 public health emergency (PHE) ends. This guidance...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In this week's Report: Woodcock...more
On December 22, 2021, the U.S. Food and Drug Administration (FDA) published two draft guidance documents intended to help medical device manufacturers transition out of the temporary rules put in place for the duration of the...more
On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) from reviewing laboratory-developed...more
The U.S. Food and Drug Administration (FDA) has issued new guidance for COVID-19 test developers to evaluate the impact of emerging and future viral mutations on COVID-19 tests. The SARS-CoV-2 virus has mutated over time,...more
2/25/2021
/ Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Infectious Diseases ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Product Labels ,
Public Health Emergency ,
Research and Development ,
Virus Testing
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
In Tuesday's Report: the expanding role of real-world evidence in FDA medical device submissions; President-elect Joe Biden lays out COVID-19 plan; Pfizer announces vaccine efficacy; and an analysis of material adverse change...more
On July 24, 2020, the U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use...more
On June 16, the U.S. Food and Drug Administration (FDA) posted updates to their Molecular Diagnostic Templates for developers that intend their assay to be used for pooled patient samples or for screening asymptomatic...more
U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more
3/30/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Clinical Laboratories ,
Coronavirus/COVID-19 ,
Diagnostic Tests ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Legislative Agendas ,
Proposed Legislation ,
Public Health Service Act ,
Regulatory Oversight
On Wednesday, March 18, the U.S. Food and Drug Administration published the guidance “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic."...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
3/17/2020
/ Biopharmaceutical ,
Biotechnology ,
Centers for Disease Control and Prevention (CDC) ,
China ,
Clinical Trials ,
Coronavirus/COVID-19 ,
Crisis Management ,
Emergency Management Plans ,
Food and Drug Administration (FDA) ,
Good Clinical Practices ,
Infectious Diseases ,
Institutional Review Board (IRB) ,
Italy ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Netherlands ,
Public Health ,
Reimbursements ,
Research and Development ,
Supply Chain ,
Travel Restrictions ,
Trump Administration ,
UK ,
Vaccinations ,
Vendors ,
World Health Organization