article thumbnail

Labcorp Offers Observed Collections of COVID-19 PCR testing in Over 500 Patient Service Centers

HIT Consultant

What You Should Know: Labcorp announced that it is offering an observed collection of COVID-19 PCR testing in over 500 patient service centers nationwide. In addition, Labcorp COVID-19 PCR tests may be conducted at doctors’ offices, hospitals and health systems, urgent care facilities and many drive-thru testing sites.

article thumbnail

The FDA Ramps Up GMP Inspections

Dot Compliance

Prior to the COVID-19 pandemic, during fiscal year (FY) 2019 (October 1, 2018, through September 30, 2019), the FDA conducted 7,266 GMP inspections of registered drug, device and biologics establishments. The post <strong>The FDA Ramps Up GMP Inspections</strong> appeared first on Dot Compliance.

FDA 52
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Unlocking the mRNA Platform Technology: Walking the Talk with Investment Protection

Bill of Health

By Aparajita Lath Two articles published last month in the BMJ analyze the public investment and financing of mRNA COVID-19 vaccines, highlighting the extensive government funding that has supported the development of mRNA technology from 1985 to 2022. government. It is generally known that the U.S.

article thumbnail

It’s Time for the Federal Government to Get Back to Protecting the Nation Against COVID-19

Bill of Health

Over the past two years, the Supreme Court has shown unprecedented hostility to efforts by both state and federal government to stop the spread of what every day turns out to be an even more deadly pandemic. These decisions are devastating, and likely signal a continued attack on government authority , but they are not a reason to give up.

COVID-19 293
article thumbnail

COVID-19 At-Home Tests: Do CLIA Requirements Apply and what do Health Care Providers Need to Know?

Healthcare Law Today

Demand for COVID-19 tests, including over-the-counter at-home tests, has soared with the surge of the Omicron variant of the COVID-19 virus. The Guidance Documents describes when a CLIA certificate is necessary for at-home COVID-19 tests. Below we summarize the highlights of that guidance.

article thumbnail

Heart Disease: Still the Silent Killer Despite Prevention Options

HIT Consultant

John Auerbach, SVP Federal Health, ICF Given the attention paid to the devastating impact of COVID-19, one might assume it was the leading cause of death in the US. million Americans died of COVID in the last 4 years – heart disease remains the largest cause of death and by a landslide.

article thumbnail

Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

Experts’ Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care. A New Way to Contain Unaffordable Medication Costs – Exercising the Government’s Existing Rights. 2022 Feb 19. Emergency Use Authorizations of COVID-19-Related Medical Products.

FDA 205