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Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid | King & Spalding

Development of Biosimilar and Interchangeable Biological Products During the COVID-19 Pandemic: What the ANDA Guidance Left Unsaid | King & Spalding
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COVID-19 Medical Products Supply Chain Week in Review – April 2021 #2 | Alston & Bird

In the past week, President Biden announced a new vaccination progress target, while the Baltimore facility incident affected Johnson & Johnson’s vaccine delivery. In addition, the FDA. ....

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Alston & Bird Health Care Week in Review - April 2021 #2 | Alston & Bird

Below is Alston & Bird’s
Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, CMS issued its proposed FY 2022 payment updates for inpatient psychiatric and rehabilitation facilities, hospice, and skilled nursing facilities. Read more about the updates and other news below.
I. Regulations, Notices & Guidance
On April 5, 2021, the Food and Drug Administration (FDA) issued guidance entitled,
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic Questions and Answers Guidance for Industry. FDA is issuing this guidance to provide general recommendations to prospective applicants and applicants of abbreviated new drug applications (ANDAs) related to generic drug product development and regulatory submis ....

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