Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The 2022 update to the Current Procedural Terminology (CPT) codes from the […]
Many Americans are clamoring for a booster dose of a COVID-19 vaccine after reports of rising numbers of breakthrough infections. Demand only increased after the Biden administration […]
Consumer advocacy group Public Citizen filed a lawsuit today on behalf of the Post-Finasteride Syndrome Foundation (PFSF) against the US Food and Drug Administration (FDA) for […]
Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The Biden administration still plans to offer COVID-19 vaccine booster shots starting […]
[embedded content] FDA Drug Info Rounds pharmacists discuss how FDA works with both domestic and foreign drug manufacturers to help ensure that products distributed within the […]
[embedded content] What is Expanded Access? FDA Chief Project Manager Monica Hughes discusses a potential pathway for a seriously ill patient to gain access to an […]
[embedded content] FDA Chief Project Manager Monica Hughes provides step-by-step instructions on completing Form FDA 3926 for follow-up submissions. Content current as of: 09/16/2019 Regulated Product(s)
[embedded content] FDA Chief Project Manager Monica Hughes provides an overview on the submission process for emergency and non-emergency expanded applications from the initial request to […]
Form FDA 3926 is a one-page form, front and back. Detailed instructions are available on the FDA website. Form FDA 3926 covers both initial and follow-up […]
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