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Orphan Status for Gileads Antiviral Remdesivir

[ Price : $8.95]

FDA approves orphan drug status for Gileads antiviral remdesivir that is being tested as a possible Covid-19 treatment.

Fecal Microbiota for Transplantation Safety Alert

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FDA says there is a risk of transmitting the SARS-CoV-2 virus through fecal microbiota for transplantation and additional safety p...

Lilly Delays New Studies Under Virus Crisis

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Faced with many challenges to the healthcare system during the coronavirus outbreak, Eli Lilly decides to delay most new study sta...

Guide on Cigarette Packages/Advertisements

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Federal Register notice: FDA publishes a final guidance entitled Submission of Plans for Cigarette Packages and Cigarette Advertis...

Info Request on Combo Product Designations

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Federal Register notice: FDA seeks comments on an information collection extension related to its guidance entitled Combination Pr...

Guide on Compounding Hand Sanitizers

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Federal Register notice: FDA makes available a guidance entitled Policy for Temporary Compounding of Certain Alcohol-Based Hand Sa...

Trump Doubles Down on Off-label Malaria Drug

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President Trump continues promoting the malaria drug chloroquine for immediate off-label use to combat the coronavirus.

Insulin, Other Biologics Transition to New Pathway

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FDA says today (3/23) is the first day that insulin and certain other biologic drugs transition to a different regulatory pathway.

Guidance on REMS Testing During Virus Outbreak

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FDA releases a guidance entitled Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency.

Point-of-Care Coronavirus Test Authorized

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FDA issues an emergency use authorization for Cepheids point-of-care coronavirus diagnostic, the Cepheid Xpert Xpress SARS-CoV-2 t...