FDA Statement on Vaccines, Related Biological Products Advisory Committee Meeting

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

Silver Spring, MD – Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 Coronavirus vaccine, the U.S. Food and Drug Administration (FDA) has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.

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FDA Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

Silver Spring, MD – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug baricitinib, in combination with remdesivir, for the treatment of suspected or laboratory confirmed COVID-19 Coronavirus in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

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FDA Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Pfizer COVID-19 Vaccine Candidate

Silver Spring, MD – The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10th, 2020 to discuss the request for emergency use authorization (EUA) of a COVID-19 Coronavirus vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH.

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FDA Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the first COVID-19 Coronavirus diagnostic test for self-testing at home and that provides rapid results.

The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 Coronavirus.

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FDA Takes Actions to Help Lower U.S. Prescription Drug Prices

Silver Spring, MD – On Thursday, September 24th, 2020, the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration took actions to help provide safe, effective, and more affordable drugs to American patients as part of the Safe Importation Action Plan, fulfilling the aspect of the July Executive Order on drug pricing to complete the rulemaking to allow states to import certain prescription drugs from Canada.

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FDA Coronavirus (COVID-19) Update: August 16th, 2020

Washington, D.C. – The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) to Yale School of Public Health for its SalivaDirect COVID-19 Coronavirus diagnostic test, which uses a new method of processing saliva samples when testing for COVID-19 Coronavirus infection.

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FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have COVID-19 Coronavirus symptoms or who have no reason to suspect COVID-19 Coronavirus infection, and to allow pooled sample testing.

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FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone

Silver Spring, MD – The U.S. Food and Drug Administration has announced it is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to recommend that as a routine part of prescribing these medicines, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment.

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Coronavirus (COVID-19) Update: FDA Issued Emergency Use Authorization for Point of Care Antigen Test

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for a COVID-19 Coronavirus antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2.

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FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) further assisted health care providers around the country prepare for the upcoming flu season during the COVID-19 Coronavirus pandemic by issuing an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 Coronavirus by their healthcare provider to the U.S. Centers for Disease Control and Prevention (CDC).

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