COVID-19

01
Jun

Consolidation of Publication for EUAs for Medical Devices Announced in the Federal Register

The Federal Register (FR), in a pre-publication notice today (here), outlined the general process for the authorization and issuance of emergency use authorizations (EUAs) similar to the ones they have been issuing during the COVID-19 pandemic.  The FDA is (as are other Agencies of the government) authorized to issue EUAs and are required to publish […]

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21
May

List of Firms That Have Removed COVID-19 Diagnostic Tests

Most of the diagnostic tests that are currently being marketed for detecting COVID-19 are subject to emergency use authorizations (EUAs).  Today, the FDA published a listing of commercial manufacturers of serological tests who had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have […]

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12
May

Senate Hearing On COVID 19 and Yes, Fauci Did Testify

Drs. Anthony Fauci (National Institute of Allergy and Infectious Diseases, NIH), Robert Redfield (Director, CDC), Stephen Hahn (Commissioner, FDA), and Brett Giroir (Assistant Secretary for Health, HHS) testified this morning before the Senate Committee on Health, Education, Labor, and Pensions, chaired by Senator Lamar Alexander.  The goal of the hearing is to identify what went […]

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08
May
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Even In the Face of COVID 19, the Beat Still Goes On

Although though we are in the grips of a pandemic and our attention is focused on the development of treatments and vaccines for COVID-19, manufacturing of drug products to treat other conditions is continuing, and GMPs must still be maintained. Sponsor companies continue to manufacture products and are still dependent upon products and services from […]

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07
May

Fast on the Trigger COVID-19 Response for Shortage Drugs

Looking over the daily COVID-19 updates from the FDA (here), I noticed that the OGD had approved “two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation: succinylcholine chloride injection USP 200 mg/10 mL and cisatracurium besylate injection USP 20 mg/10 mL.”  Glad to see that […]

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04
May

Silver Ain’t No Silver Bullet – It’s Fraud, Says DOJ

The FDA posted a Department of Justice press release discussing a temporary injunction against a Utah firm from selling and marketing silver products as a prevention and cure for the corona virus. The press release states “The Department of Justice will take swift action to protect consumers from those who would recklessly exploit this public […]

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01
May
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FDA Grants EUA for Remdesivir

No, this is not an approval, but it is an emergency use authorization to use the antiviral Remdesivir for COVID 19 patients.  The FDA issued this EUA on Friday, in record time, after positive results of the study involving Gilead’s drug.  The EUA will remain in effect until the COVID 19 public health emergency is […]

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