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Food and Drug Amendments of 2022 (PDUFA VII) | Alston & Bird

Our FDA and Health Care Policy teams discuss how sponsors and manufacturers can prepare for legislative and regulatory changes that could come from the final Food and Drug Amendments. ....

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And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package | King & Spalding

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user. ....

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Shared Qualification Audits A Win-Win-Win Approach

Throughout the pandemic, the FDA has demonstrated more than ever the value of using a risk-based approach to inspectional activities, which must be. ....

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Pfizer And BioNTech To Request Approval For Vaccine Use In 12-To-15-Year-Olds – Medical Products Supply Chain Week In Review - Food, Drugs, Healthcare, Life Sciences

In the past week, Pfizer and BioNTech announced they will request full approval from the FDA for the use of their COVID-19 vaccine in adolescents 12–15 years of age. ....

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Pfizer and BioNTech to Request Approval for Vaccine Use in 12-to-15-Year-Olds – Medical Products Supply Chain Week in Review | Alston & Bird

In the past week, Pfizer and BioNTech announced they will request full approval from the FDA for the use of their COVID-19 vaccine in adolescents 12–15 years of age. They also plan to. ....

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