COVID-19

12
Oct

Hand Sanitizer Supply Sufficient, Says FDA

In a prepublication Federal Register (FR) notice (here), the “Food and Drug Administration (FDA or Agency) is announcing the withdrawal of three guidance documents titled ‘Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),’ ‘Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health […]

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08
Sep
Hanging word Q&A

Q&A Guidance on Development of Generic Drugs During the COVID 19 Emergency

Today, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here).  This guidance responds to questions that have been asked by sponsors since the pandemic began, covers a multitude of issues, and outlines some areas of relief for applicants.  Remember that the answers […]

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08
Apr

False Negative COVID-19 Tests Further Complicated by Variants

The FDA notes that many of the emergency use authorization (EUA) tests currently being utilized are subject to false-negative results.  The FDA emphasizes (here) that variants seen in the virus may have a significant impact on COVID-19 tests and this will likely occur with greater frequency, especially as some of the variants become predominant in […]

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06
Apr

Guidance for ANDAs –Development During Covid-19 – Q&A Document

Yesterday, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here).  The guidance covers three broad areas: Generic drug product development ANDA submission and assessment and Marketing and exclusivity. The guidance offers many hints on how the Agency may deal with issues that […]

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05
Mar
Vials

Vial and Component Relief from the FDA for the Vile component Shortage Created by the Pandemic

FDA has proposed some relief from the component shortages created for parenteral and other products identified in the just released Guidance entitled, COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers. The Agency has recognized the need to provide some regulatory flexibility regarding the filing type for certain changes that may be necessitated […]

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24
Feb
Corona Virus covid-19 illustration

Staying Ahead of SARS-CoV-2 Variants as You Develop Your Monoclonal Antibody Products

As we have seen in the news lately, the SARS-CoV-2 virus is spinning out new variants as it replicates in infected individuals.  Some of these new variants have been found to be more infectious (and possibly more pathogenic) than the initial virus that first entered the human population.  The good news is that the FDA […]

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19
Jan

Outlining COVID-19 Safety Expectations for ANDA BE Studies

On January 15, 2021, the FDA issued the guidance titled “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”.  This guidance provides recommendations to study sponsors for the continuation or initiation of their bioequivalence (BE) studies during this COVID-19 public health emergency.  As is no surprise, FDA clearly […]

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