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Moderna, among the front-runners looking for authorization for a COVID-19 vaccine, was established in 2010 and has never ever had a product gain FDA approval. Its never ever been inspected by the FDA, Bloomberg reported..
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FDA regulations do not require preapproval evaluations for items looking for emergency situation usage authorization, Jerry Weir, PhD, director of the department of viral items at the FDA told Bloomberg..
The FDA generally examines a drugmakers facility prior to it approves a new drug to determine if there are any quality issues in the manufacturing process. © Copyright ASC COMMUNICATIONS 2020. Interested in LINKING to or REPRINTING this material?
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Maia Anderson –
Tuesday, October 27th, 2020
The FDA will not require evaluations of vaccine makers production facilities before a COVID-19 vaccine gets emergency use permission, Bloomberg reported..
The FDA typically examines a drugmakers center prior to it authorizes a new drug to identify if there are any quality issues in the production procedure. An evaluation can identify whether a drugmaker has handled quality problems or is neglecting them. A FDA assessment recently found quality assurance concerns with an Eli Lilly plant in New Jersey that makes its COVID-19 antibody drug..
Dr. Weir informed Bloomberg that vaccine developers seeking emergency usage permission will have to send total information of their production process to reveal theyve developed a quality assurance system..