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Medical Supplies Manufacturers Reporting Requirements

Hogan Lovells

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

Hogan Lovells on

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...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

Hogan Lovells

Spain responds to COVID-19 with new reporting obligations, supply chain controls

Hogan Lovells on

The Spanish Ministry of Health placed on manufacturers and marketing authorization holders (MAHs) – or their local representatives – new reporting, supply, and manufacturing obligations with respect to 347 medicinal products...more

Cooley LLP

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

Cooley LLP on

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug,...more

Stinson LLP

Health Law Alert: Final Sunshine Act Regulations Released

Stinson LLP on

On Friday, February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) released the long-awaited Sunshine Act regulations. The Sunshine Act requires disclosure of payments and value transfers (Payments) from drug and...more

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