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Manufacturers New Guidance Supply Chain

Latham & Watkins LLP

IRS Safe Harbor Eases Path for Domestic Content Bonus Tax Credits

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IRS Notice 2024-41 provides taxpayers with a clearer path toward qualifying for domestic content bonus tax credits through a new elective safe harbor....more

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

Quarles & Brady LLP on

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

BakerHostetler

Overview and Observations of Notice 2023-38 - Domestic Content Bonus Requirements

BakerHostetler on

On May 12, 2023, the Internal Revenue Service (IRS) issued initial guidance in the form of the Notice that provides taxpayers with preliminary guidance relating to the application of the domestic content bonus requirements...more

Morgan Lewis - As Prescribed

Tracking Back to Track and Trace: Additional Guidance on Compliance with the DSCSA

Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more

Akin Gump Strauss Hauer & Feld LLP

International Trade Impacts of The Coronavirus: Update On Government And Industry Actions And Key Considerations For Trade...

The new coronavirus, SARS-CoV-2, and the disease it causes, COVID-19, have created diverse, complex, and immediate challenges for world governments, multinational businesses, and other international institutions and projects....more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

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