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