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August 23, 2021

Drug Master File (DMF) Submission Resources

The draft guidance for industry Drug Master Files describes how to prepare and submit DMFs. Here are some additional resources: Requesting a Pre-Assigned Application Number: To […]
August 23, 2021

Though Young and Healthy, Unvaccinated Father Dies of COVID Though Young and Healthy, Unvaccinated Father Dies of COVID

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. MONTGOMERY, Ala. (AP) — Healthy and in their 30s, Christina and Josh […]
August 23, 2021

Florida Mayor Urges Water Limits Because of COVID-19 Surge Florida Mayor Urges Water Limits Because of COVID-19 Surge

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. ORLANDO, Fla. (AP) — The mayor of the Florida city of Orlando […]
August 23, 2021

Mask, Vaccine Conflicts Descend Into Violence and Harassment Mask, Vaccine Conflicts Descend Into Violence and Harassment

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. PHOENIX (AP) — The Hawaii lieutenant governor watched in horror as protesters […]
August 23, 2021

Parents Get Coached on How to Escape Mask and Vaccine Rules Parents Get Coached on How to Escape Mask and Vaccine Rules

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. Alsea School District Superintendent Marc Thielman poses for a portrait on the […]
August 23, 2021

School Mask, Vaccine Mandates Supported in US: AP-NORC Poll School Mask, Vaccine Mandates Supported in US: AP-NORC Poll

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. BOSTON (AP) — As COVID-19 cases surge around the country, a majority […]
August 23, 2021

Mississippi: Have COVID-19? Isolate or Face Fines, Jail Time Mississippi: Have COVID-19? Isolate or Face Fines, Jail Time

Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center. The Mississippi Department of Health issued a COVID-19 isolation order on Friday […]
August 23, 2021

Henan Lihua Pharmaceutical Co., Ltd. – 548089 – 08/12/2021

Reference #: FEI 3001164052 Product: Drugs Recipient: Recipient Name Mr. Nui Zhigang Recipient Title General Manager Henan Lihua Pharmaceutical Co., Ltd. Middle of Huanghe StreetAnyang ShiHenan […]
August 23, 2021

Three-Dimensional (3D) Cell Culture (Microphysiological) Platforms as Drug Development Tools

CDER researchers are investigating cell culture platforms that can supplant the need for animal testing or clinical trials in specific regulatory contexts. These platforms recreate three-dimensional […]
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