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Today, the U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms…
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On December 15, 2021,…
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: On December 9, 2021,…
The following quote is attributed to CDRH’s William Maisel, M.D.,M.P.H., director of the Office of Product Evaluation and Quality and Ed Margerrison, Ph.D., director of…
Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster…
The U.S. Food and Drug Administration has a longstanding commitment to strengthening food safety and better protecting consumers, as part of its public health agenda….
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the…
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA updated the…
The following quote is attributed to Acting FDA Commissioner Janet Woodcock, M.D. “Progress in individualized medicines provides hope to patients with severely debilitating or life-threatening…
Today, the U.S. Food and Drug Administration revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of…
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FDA Acts to Protect Children from Unapproved Fluoride Drug Products