Archive for: FDA

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Diagnostics

FDA updates its FAQ on COVID-19 testing and gives EUA to additional tests

On March 28, FDA again updated its FAQ regarding specimen collection for COVID-19 testing.

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Diagnostics

FDA updates its FAQ on COVID-19 testing and gives EUA to additional tests

On March 23, FDA updated its FAQ regarding specimen collection for COVID-19 testing.

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Diagnostics

FDA issues guidance on unauthorized fraudulent COVID-19 test kits

On March 20, the FDA issued new guidance alerting consumers about the unauthorized, fraudulent COVID-19 test kits.

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Diagnostics

FDA gives EUA for first point-of-care COVID-19 test

Since March 19, the FDA announced four additional Emergency Use Authorizations granted for diagnostic tests for COVID-19 including the first point-of-care test.

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Diagnostics

FDA gives EUA to additional tests for diagnostic testing for COVID-19

Since March 17, the FDA announced three additional Emergency Use Authorizations granted for diagnostic tests for COVID-19.

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Diagnostics

FDA gives EUA to additional tests and issues policy on diagnostic testing for COVID-19

Since March 13, the FDA announced three additional Emergency Use Authorizations granted for diagnostic tests for COVID-19.

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Diagnostics

FDA took two additional steps in response to the coronavirus (COVID-19) outbreak

On March 12, 2020, the FDA took two additional steps to address the coronavirus (COVID-19) outbreak.

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Diagnostics

Congress Introduces New Legislation for Diagnostics Regulation

Reps. Larry Bucshon, R-Ind., and Diana DeGette, D-Colo., introduced the Verifying Accurate Leading-edge IVCT Development Act of 2020 (VALID).

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Diagnostics

FDA Posts a Number of New Items Related to Coronavirus

On February 29, 2020, the FDA issued a new guidance document (immediately in effect) on its policy for diagnostic testing in laboratories certified to perform high complexity testing under CLIA prior to EUA for COVID-19 during the public health emergency.

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Diagnostics

FDA Issues Two CLIA-Related Final Guidance Documents

The FDA issued two final guidance documents.

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Payment Innovation: Other

CMS Seeks to Expand Services through Recent Coverage Decisions (Acupuncture for Low Back Pain and NGS for Advanced Breast and Ovarian Cancer)

Centers for Medicare and Medicaid Services has announced two coverage decisions that will provide access to previously uncovered services for Medicare FFS beneficiaries.

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Prescription Drug: Litigation

Judge Axes Price Disclosure Rule for Drug Ads

  The Trump administration cannot force drug manufacturers to disclose prices in their pharmaceutical ads to consumers, a federal judge ruled Monday.  

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Diagnostics: Guidance

FDA Releases Draft Guidance and Announces Webinar on CLIA Waiver Applications

The FDA has updated and released two draft guidance documents that aim to help manufacturers of in vitro diagnostic devices apply for and receive CLIA waivers.

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