COVID-19

04
Aug

Pharma’s Fight Against the Coronavirus Pandemic

A look at the pharma industry’s concerted effort to develop vaccines against the SARS-CoV-2 virus and therapeutics to treat COVID-19. Contract Pharma recently published an article authored by Keith O. Webber, Lachman Consultants. He says, “Although we are faced with significant challenges, hopefully the recently published guidance documents from the FDA in conjunction with the […]

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15
Jun

FDA Revokes Emergency Use Authorization for Chloroquine Phosphate and Hydroxychloroquine Sulfate

In an FDA new release (here), the Agency announced that it was pulling its EUA saying they “determined that the legal criteria for issuing an EUA are no longer met”.  The Agency took this action after a review of the current state of knowledge on the two drugs relative to their unproven efficacy and serious […]

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02
Jun

Additional Guidance on Hand Sanitizer – Preparation, Manufacture and Temporary Compounding: The Bar is Raised

FDA issued three updated guidance documents that have revised recommendations and additional information on the preparation, manufacture, and temporary compounding of hand sanitizers under the COVID-19 public health emergency.  The Agency provides additional guidance on the use of both active and inactive ingredients, updates permitted formulation and denaturing processes, and discusses permissible levels of impurities […]

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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
Document Issued for Manufacturing Facility Information Image

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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