FDA Law Blog

APRIL 19, 2021

The Court decision limiting FDA’s discretion provides regulatory certainty for device manufacturers, as the claimed discretion, if recognized by the Court, would have meant that any medical device potentially could be classified and regulated as a drug.

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FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. You can find our preliminary blog post on the release of this guidance here , and our blog posts on the draft CDS guidances here and here.

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FDA Law Blog

OCTOBER 6, 2023

The crux of the proposed rule lies in the addition of ten words: “ including when the manufacturer of these products is a laboratory.” These words would be added to the definition of “ in vitro diagnostic [IVD] products” in 21 C.F.R. But, by statute all devices not previously classified are automatically placed into Class III.

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Conflict of Laws

MAY 17, 2022

Since 2014 the American Law Institute2 now seeks to draft a new “Restatement” – the Third – of the subject, with the aim to clarify and perhaps to bring more uniformity to the resolution of conflict-of-laws problems. Examples drawn from existing drafts of new provisions may serve to venture some evaluation of these proposed changes.

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Foley Hoag LLP

JANUARY 28, 2022

If passed and signed into law, the Act would create significant reporting requirements related to environmental sustainability, social development (in particular worker rights), and ethical business (ESG) standards for retailers and manufacturers. Companies would have twelve months to map out a minimum of 50% of their supply chain by volume.

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FDA Law Blog

MAY 14, 2021

387 (notes to statute, § 3, ¶ 7). In response to this, the FDA announcement pointed out that any ban on menthol cigarettes will only address manufacturers, distributors, wholesalers, importers and retailers: “the FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any tobacco product.”.

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JonathanTurley

DECEMBER 19, 2021

An example is the recent New York public nuisance law seeking to make gun manufacturers liable for gun crime. I’ve discussed the New York public nuisance law aimed at gun manufacturers, a law that doubles down on a failed legal theory using torts as a substitute for direct legislative bans or barriers.

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FDA Law Blog

MAY 14, 2021

387 (notes to statute, § 3, ¶ 7). In response to this, the FDA announcement pointed out that any ban on menthol cigarettes will only address manufacturers, distributors, wholesalers, importers and retailers: “the FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any tobacco product.”.

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Manufacturing Drafting Statute Litigation 40

ClimateChange-ClimateLaw

OCTOBER 20, 2020

1442, or the civil-rights removal statute, 28 U.S.C. The district court rejected eight grounds for removal, but the Fourth Circuit concluded its appellate jurisdiction was limited to determining whether the companies properly removed the case under the federal-officer removal statute. Truck Trailer Manufacturers Association, Inc.

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ClimateChange-ClimateLaw

APRIL 9, 2021

In Minnesota, the district court granted the State of Minnesota’s motion to remand its case, which asserts state law claims under common law and consumer protection statutes. s consumer protection statute. Federal Court Directed Department of Interior to Search for Drafts of Zinke Order Rescinding Moratorium on Coal Leasing Program.

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ClimateChange-ClimateLaw

FEBRUARY 10, 2020

In a separate order, the court granted the motions of states and American Fuel & Petrochemical Manufacturers to intervene in support of the respondents. The court said the petitioner’s comments on the draft and final EIRs concerning the analysis of greenhouse gas emissions were not sufficient to exhaust administrative remedies.

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