Alexa S. Rummel

Alexa S. Rummel

Akin Gump Strauss Hauer & Feld LLP

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FDA Issues Draft Guidance on Equity, Diversity and Individual Sponsor Financial Ability Considerations in Charging for...

On August 23, 2022, the United States Food and Drug Administration (FDA or the “Agency”) published the revised draft guidance “Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry” (the...more

9/22/2022  /  Draft Guidance , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

Senate HELP Committee Unveils Draft FDA User Fee Reauthorization Legislation, with Major Reforms to In Vitro Diagnostics,...

On May 17 the Senate Health, Education, Labor and Pensions (HELP) Committee released a bipartisan legislative discussion draft of the Food and Drug Administration (FDA) Safety and Landmark Advancements Act (FDASLA), which...more

5/24/2022  /  Biologics , Biosimilars , Food and Drug Administration (FDA) , GDUFA , Generic Drugs , Medical Devices , PDUFA , Prescription Drugs , User Fees
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