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Pharmaceutical Industry › Compliance › Supply Chain

ArentFox Schiff

FDA’s Remote Regulatory Assessments Enhance DSCSA Compliance With Technology-Driven Oversight

ArentFox Schiff on

On June 25, the US Food and Drug Administration (FDA) released a final guidance, “Conducting Remote Regulatory Assessments: Question and Answers.”...more

Husch Blackwell LLP

Say Goodbye to the Red Dye: Legal Implications Following the FDA’s Recent Ban

Husch Blackwell LLP on

On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...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

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

American Conference Institute (ACI) on

ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more

Society of Corporate Compliance and Ethics...

A look at the EU Market Surveillance Regulation

Society of Corporate Compliance and Ethics... on

Report on Supply Chain Compliance 3, no. 21 (October 29, 2020) - The European Union has some of the world’s most robust environmental, health and safety standards for products sold and imported into the market. Despite...more

Proskauer - Minding Your Business

Beyond the Pandemic: Pharmaceutical Industry Compliance Considerations

Proskauer - Minding Your Business on

Since the ongoing states of emergency were put in place in response to a health crisis, pricing in the pharmaceutical industry is under more of a microscope than usual. While the immediate focus may be on products that are...more

Society of Corporate Compliance and Ethics...

United States senator proposes changes to improve security of medical product supply chain

Society of Corporate Compliance and Ethics... on

Report on Supply Chain Compliance 3, no. 5 (March 5, 2020) - Republican Sen. Josh Hawley of Missouri announced via Twitter that he would introduce legislation to protect the U.S. medical product supply chain following its...more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

King & Spalding

General Counsels Decision Tree for Investigations of Life Sciences Companies

King & Spalding on

Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more

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