Elizabeth Richards

Latham & Watkins LLP

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Latest Posts › Federal Food Drug and Cosmetic Act (FFDCA)

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HHS Issues Policy Statement to Expand Use of Rulemaking Without Notice and Comment

The policy statement aims to bring more rapid action on personnel and management decisions and empowers HHS and each of its offices and subagencies to promulgate or rescind certain rules without a period of notice and comment...more

3/6/2025 / Administrative Procedure Act , Centers for Disease Control and Prevention (CDC) , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Notice and Comment , Policy Statement , Regulatory Reform , Rulemaking Process

FDA Releases Final Guidance on Considerations for the Use of Real-World Data and Real-World Evidence

The Guidance amends the 2021 draft guidance regarding products used under an Emergency Use Authorization and use of patient-level data from third parties. On August 31, 2023, the US Food and Drug Administration (FDA or...more

11/3/2023 / Federal Food Drug and Cosmetic Act (FFDCA) , Final Guidance , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA Announces Planned Changes to the 510(k) Premarket Notification Program

Agency signals forthcoming changes that could impact manufacturers’ ability to commercialize new medical devices. Background - On November 26, 2018, officials from the Food and Drug Administration (FDA or the Agency)...more

12/3/2018 / 510(k) RTA , FDA De Novo Clearance , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Regulatory Agenda

FDA Reauthorization Act Aims to Speed Product Reviews Through User Fee Funding

Congress passes sweeping user fee reauthorization bill to fund increased FDA staffing and support commitments to product review timelines. Key Points: ..Congress authorized FDA to collect increased total annual user...more

8/9/2017 / Abbreviated New Drug Application (ANDA) , Biosimilars , FDARA , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Funding , GDUFA , Pharmaceutical Industry , Prescription Drugs , User Fees

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