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Medical Testing Coronavirus/COVID-19 Food and Drug Administration (FDA)

Patrick Malone & Associates P.C. | DC Injury...

Better Healthcare Newsletter from Patrick Malone - May 2021

IN THIS ISSUE Home medical tests and health monitors are trendy now. How useful are they? As the saying goes: Let the buyer beware - Shaking up hidebound medicine could be a plus. But will key safeguards also stay?...more

Arnall Golden Gregory LLP

HHS to Distribute Rapid COVID-19 Tests to Home Health and Hospice Providers

On August 27, 2020, the federal government announced that it has partnered with Abbott Laboratories to produce rapid point-of-care COVID-19 tests and has purchased 150 million tests for distribution to certain healthcare...more

Alston & Bird

Alston & Bird Health Care Week in Review - September 2020 #2

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Arnall Golden Gregory LLP

Applying For or Updating a CLIA Waiver During The Pandemic

While much of the COVID-19 testing has been done by government and private dedicated laboratories, many providers in the acute and long-term care space are moving towards providing their own CLIA-waived tests.  ...more

Patterson Belknap Webb & Tyler LLP

FDA Releases Industry Guidance on Development and Licensure of COVID-19 Vaccines

The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020. This nonbinding guidance is intended to remain in effect for the duration...more

Patterson Belknap Webb & Tyler LLP

FDA Releases COVID-19 Vaccine Guidance for Industry

On June 30, 2020 the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research released its first “Guidance for Industry” document for the development and licensure of COVID-19 vaccines. While the...more

BakerHostetler

FDA and State Boards of Pharmacy React to COVID-19 – June Update

BakerHostetler on

This update approaches three months of coverage of the Food and Drug Administration (FDA) and related regulatory response to COVID-19. Updates and developments continue in the COVID-19 response despite a decrease in media...more

Greenbaum, Rowe, Smith & Davis LLP

New Jersey Authorizes Pharmacists to Conduct COVID-19 Testing

There is substantial support for the view that reliable widespread testing is essential to the restoration of a semblance of normalcy in New Jersey when considering the impact of the COVID-19 pandemic.  In connection with...more

ArentFox Schiff

Big Changes in FDA’s Serology/Antibody Testing Requirements

ArentFox Schiff on

On May 4, 2020, the FDA issued new Guidance that drastically changes the requirements for serology/antibody tests for the COVID-19 epidemic. The Agency did this by updating (and superseding) previous February 29, and March...more

Akin Gump Strauss Hauer & Feld LLP

COVID-19 Policy Update #15

Congress, Administration Reach $484 Billion Deal for Phase 3.5 - Yesterday, congressional Democrats and Republicans reached a $484 billion deal with the Trump Administration for “Phase 3.5” of the coronavirus response to,...more

Bass, Berry & Sims PLC

Thinking of Using Serology Testing for COVID-19? Don’t Overlook CLIA Certification Rules

Bass, Berry & Sims PLC on

With the spread of COVID-19, healthcare providers—including those that are more easily accessible to patients, like primary care practices and urgent care clinics—are looking for fast and reliable tests to diagnose infection....more

Gibney Anthony & Flaherty, LLP

Online Safety: Avoiding Counterfeit COVID-19 Testing Kits

Almost as if on cue, as the United States ramps up testing and containment measures, US Customs and Border Protection (CBP) announced its first seizure of counterfeit COVID-19 test kits at the Los Angeles Airport...more

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