Chris McAndrew

Chris McAndrew

Wilson Sonsini Goodrich & Rosati

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Latest Posts › Food and Drug Administration (FDA)

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HHS Names the First 10 Drugs for Medicare Price Negotiation

Listening Sessions on Drug Price Negotiations Will Be Live Streamed and Opened to the Public This Fall - In this Alert, we provide an update regarding the first 10 drugs for Medicare price negotiation selected under the...more

9/6/2023  /  Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Food and Drug Administration (FDA) , Medicare , Medicare Part D , Pharmaceutical Industry , Prescription Drugs

FDA's Proposed Rules to Address Inaccurate Orange Book Use Codes May Shorten Approval Timelines for Select 505(b)(2) and Generic...

Drug Approval and Patent Listing Process - Before being allowed to market a new drug1 in the U.S., branded drug manufacturers must submit a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), and...more

7/17/2015  /  Abbreviated New Drug Application (ANDA) , Food and Drug Administration (FDA) , Generic Drugs , Healthcare , Orange Book , Patents , Pharmaceutical Industry , Pharmaceutical Patents
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