Alexandre Gapihan

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Latest Posts › FDA Approval

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FDA Grants First E‑Cigarette PMTA Authorization

The US Food and Drug Administration recently issued an order authorizing R.J. Reynolds Vapor Co. to market its Vuse Solo electronic nicotine delivery system and corresponding e-liquid pods. These authorizations mark the first...more

11/11/2021 / E-Cigarettes , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Premarket Approval Applications , RJ Reynolds , Tobacco , Tobacco Regulations , Vaping

FDA Reinstates Unapproved New Drug Initiative

In a May 27 Federal Register notice, the US Department of Health and Human Services (HHS) announced the reinstatement of the Unapproved Drugs Initiative, the FDA’s compliance policy governing marketed unapproved drugs. The...more

6/11/2021 / Department of Health and Human Services (HHS) , Enforcement Programs , FDA Approval , Food & Drug Regulations , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

FDA Issues New Temporary Policy for the Manufacture of Alcohol for Hand Sanitizer Products

In light of the hand sanitizer shortage during the coronavirus (COVID-19) pandemic, many manufacturers are seeking alternative sources of alcohol for incorporation into their hand sanitizer products. The need for alcohol has...more

3/27/2020 / Coronavirus/COVID-19 , FDA Approval , Food and Drug Administration (FDA) , Manufacturers , Medical Supplies , Over The Counter Drugs (OTC) , Relief Measures , Supply Chain

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