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Manufacturers Waivers Supply Chain

Foley & Lardner LLP

BIOSECURE Act: Anticipated Movement, Key Provisions, and Likely Impact

Foley & Lardner LLP on

Last night, the House of Representatives passed the BIOSECURE Act (BIOSECURE or the Act) by a bipartisan vote of 306 to 81.  The BIOSECURE Act prohibits federal agencies from procuring or obtaining any biotechnology...more

Miles & Stockbridge P.C.

OMB Issues Final Guidance for Buy America Preference

Almost a year to the day after the Build America Buy America Act (BABA) became law, the federal Office of Management and Budget (OMB) has published its “Final Guidance for Grants and Agreements” intended to implement BABA’s...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

White & Case LLP

Final Buy America Act Guidance Issued

White & Case LLP on

The White House issued final guidance this week governing the procurement preferences required by the Build America, Buy America Act, or BABA, for infrastructure projects. In addition to providing definitions for key terms...more

Akin Gump Strauss Hauer & Feld LLP

[Podcast] Onshoring Drug Manufacturing and TRIPS Waiver Part II

In this new episode of OnAir: Health Care, Akin Gump health care senior policy advisor Matthew Hittle and consultant Dr. Mario Ramirez welcome Akin Gump public law and policy partner Clete Willems and Centrient...more

Akin Gump Strauss Hauer & Feld LLP

Executive Order on Essential Medicines: A Timeline and Overview of Key Provisions

On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more

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