Lisa Dwyer on Coronavirus/COVID-19

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

A Pandemic Silver Lining: FDA’s New Guidance on Using Digital Health Technologies for Clinical Investigations

With spring timidly approaching, it’s hard not to dwell on the fact that we are almost two full years into the COVID-19 pandemic. The pandemic has placed into clear relief many of the access issues faced by patients and...more

2/8/2022 / Clinical Trials , Coronavirus/COVID-19 , Data Collection , Data Privacy , Digital Health , Food and Drug Administration (FDA) , Investigations , Medical Devices , New Guidance

HHS Continues Focus on Women's Health: AHRQ Calls for Data on Telehealth for Women

The Department of Health and Human Services (“HHS”) is continuing its focus on women’s health, this time through its research arm, the Agency for Healthcare Research and Quality (“AHRQ”). If the COVID-19 pandemic has shown us...more

10/19/2021 / AHRQ , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Department of Labor (DOL) , Exclusionary Clauses , Reproductive Healthcare Issues , Telehealth

Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid

There has been much discussion about FDA’s recently-issued guidance regarding the development and review of abbreviated new drug applications (“ANDAs”) during the COVID-19 pandemic. The guidance, “Development of Abbreviated...more

4/23/2021 / Abbreviated New Drug Application (ANDA) , Biosimilars , BPCIA , Coronavirus/COVID-19 , Food and Drug Administration (FDA) , Interchangeability , Marketing Exclusivity Periods , New Guidance , Pharmaceutical Patents , Public Health Service Act

The Establishment of the White House Gender Policy Council and Its Implications for FDA Initiatives and Priorities

On March 8, 2021, President Biden signed an Executive Order, establishing a Gender Policy Council (“the Council”) tasked with the broad policy goal of “advancing gender equity and equality” for the purpose of reducing...more

3/16/2021 / Biden Administration , Clinical Trials , Coronavirus/COVID-19 , Executive Orders , Food and Drug Administration (FDA) , Gender Equity , Secretary of HHS

FDA Establishes – And HHS Immediately Withdraws – New OTC Drug User Fee Rates

Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for...more

1/6/2021 / Abbreviated New Drug Application (ANDA) , CARES Act , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Over The Counter Drugs (OTC) , Public Health Emergency , User Fees

Congressional Oversight of COVID-19 Serological Testing

Trump Administration and Testing Companies Receiving Scrutiny - Throughout the COVID-19 pandemic, both viral and antibody testing have raised significant challenges for the government and private sector. As both federal...more

5/7/2020 / Centers for Disease Control and Prevention (CDC) , Coronavirus/COVID-19 , FDA Commissioner , Food and Drug Administration (FDA) , Pandemic , Re-Opening Guidelines , Trump Administration , Virus Testing

Congress Enacts OTC Monograph Reform

Last month, Congress enacted significant reforms to the over-the-counter (“OTC”) drug review process. The reforms, enacted as part of the “Coronavirus Aid, Relief, and Economic Security Act” (“CARES Act”), change...more

5/4/2020 / CARES Act , Coronavirus/COVID-19 , Food & Drug Regulations , Food and Drug Administration (FDA) , Over The Counter Drugs (OTC)

Lisa Dwyer

King & Spalding

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