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Supply Chain Pharmaceutical Industry Distributors

Arnall Golden Gregory LLP

[Webinar] Mitigating the Impact of Tariffs: A Practical Guide for Life Sciences Companies - June 17th, 12:00 pm - 1:00 pm EDT

AGG partner and Life Science team member, Allison Raley, will present a complimentary webinar examining how life sciences companies can overcome challenges in the face of U.S. tariffs. As international trade tensions persist...more

Polsinelli

FDA Issues Exemptions from November 27, 2024 Compliance Deadline for Updated DSCSA Requirements

Polsinelli on

On Wednesday, the Food and Drug Administration (FDA) issued a statement granting additional exemptions from its November 27, 2024 deadline for compliance with certain product transaction requirements.  The exemptions followed...more

Hogan Lovells

MDCG guidance on QMS certification of distributors/importers relabeling, repackaging medical devices

Hogan Lovells on

In August 2021, the MDCG issued guidance MDCG 2021-23 for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The...more

American Conference Institute (ACI)

[Virtual Event] 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - July 21st-22nd, 9:00...

Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more

Mintz - Health Care Viewpoints

FDA Delays Enforcement of Prescription Drug Product Identifier and Related Requirements

Facing pressure from stakeholders and technological realities, the U.S. Food and Drug Administration has again delayed its enforcement of parts of the Drug Supply Chain Security Act (DSCSA). As we discussed in a prior post,...more

King & Spalding

False Claims Act Update: GSA Contractor Reasonably Relied Upon Distributor Certifications Of Product Origin And Trade Agreements...

King & Spalding on

The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court’s dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

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