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Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

FDA Law

Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. Compared with the COVID-centered version of the document released in April 2021, there is very little that is new or different.

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Machine gun history

The Volokh Conspiracy

This was the first law school symposium ever on the National Firearms Act of 1934, one of the two foundational federal gun control statutes. The inclusion of SBRs and short-barreled shotguns (SBSs) was simply an effort to prevent evasion of the draft restrictions on handguns.

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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

FDA Law

Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).

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Supreme Court likely to let vape company’s FDA challenge proceed

SCOTUSBlog

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gives the FDA the power to regulate tobacco products and requires manufacturers to obtain the FDAs permission before putting a new tobacco product on the market. What arguments could you raise, she queried, that would be different than the manufacturer?

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S. Ct. Unanimously Rejects Mexico's Lawsuit Against Smith & Wesson

The Volokh Conspiracy

Estados Unidos Mexicanos : The Government of Mexico brought this lawsuit against seven American gun manufacturers. As required by a federal statute, Mexico seeks to show (among other things) that the defendant companies participated in the unlawful sale or marketing of firearms. 7903(5)(A)(iii).

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Indeterminate Change: FDA Releases Draft Guidance on Predetermined Change Control Plans for Medical Devices

FDA Law

A draft guidance issued last year focused on PCCPs for devices incorporating artificial intelligence and machine learning (AI/ML), which we blogged about here ; this guidance has not yet been finalized. Draft Guidance at 4. The Draft Guidance takes a narrower approach.

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Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

FDA Law

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The draft guidance purports to apply to current PMA holders. Draft Guidance. By Jeffrey K.