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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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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Drafting Statute Data Management Manufacturing 52

Conflict of Laws

OCTOBER 23, 2023

Statute has left little of the common law untouched. The Interaction between a Mandatory Law and an Exclusive Jurisdiction Clause Statutes generally fall into one of three categories (see Maria Hook, ‘The “Statutist Trap” and Subject-Matter Jurisdiction’ (2017) 13(2) Journal of Private International Law 435).

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Laws Contract Statute Construction 59

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 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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Manufacturing Healthcare Drafting Statute 64

Patently O

JANUARY 22, 2024

Back to terminal disclaimers : The statute appears relatively clear that patent-term-adjustment does not extend a patent term beyond that disclaimed in a terminal disclaimer. The en banc petition was well drafted and supported by strong amicus briefing. This is generally an issue that can be cured if both patents are still in-force.

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Manufacturing Drafting Statute Technology 49

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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Diligence Manufacturing Attorney Drafting 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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Court Government Compensatory Damages Litigation 72

Customs & International Trade Law

DECEMBER 27, 2024

We drafted a persuasive binding ruling request and CBP agreed with our classification and issued a binding ruling reflecting the proposed HTS classification. However, Diaz Trade Law’s claim for prior disclosure treatment was successful andno further penalty was assessed by CBP.

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eFiling Laws Small Business Manufacturing 40

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 52

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

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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Manufacturing Laws Litigation Litigating 38

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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Court Reporting Court Government Construction 40

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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