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Regulatory Requirements Waivers Manufacturers

Pillsbury Winthrop Shaw Pittman LLP

FHWA Rescinds Longstanding Buy America Waiver for Manufactured Products

On January 13, 2025, the U.S. Federal Highway Administration (FHWA) issued a final rule terminating a long-standing exception to “Buy America” domestic content requirements for manufactured products used in agency-funded...more

Ballard Spahr LLP

FHWA to Eliminate Buy America Manufactured Products Waiver for Federally-Assisted Highway Projects

Ballard Spahr LLP on

On January 14, 2025, the U.S. Department of Transportation (USDOT) Federal Highway Administration (FHWA) issued a final rule discontinuing its longstanding Buy America waiver for manufactured products used in...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

Hogan Lovells

EU SPC Manufacturing Waiver Now in Force

Hogan Lovells on

The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469).  The Waiver has been introduced with the stated aim of putting EU generic and...more

Hogan Lovells

EU: New developments in the SPC manufacturing waiver legislative process

Hogan Lovells on

Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more

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