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Life Sciences › Reporting Requirements › Manufacturers

Ropes & Gray LLP

Proposed Changes to Medicare Payment Rules: What Life Sciences Companies Need to Know

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The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more

Epstein Becker & Green

Reminder of March 31 “Right to Try” Reporting Deadline

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Pharmaceutical companies that have provided investigational drugs to patients under the Right to Try law should be prepared to comply with the U.S. Food and Drug Administration’s (FDA’s) reporting requirements by March 31,...more

Sheppard Mullin Richter & Hampton LLP

On Your Mark, Get Set, Go: Life Science Companies Face A Challenging Year For Compliance With New Open Payment Program Data...

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The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as Section 6002 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid...more

Hogan Lovells

FDA updates VMSRP instructions for summary MDR reporting – including reasons for possible program exclusion

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Last week, the U.S. Food and Drug Administration (FDA) updated the information regarding its Voluntary Malfunction Summary Reporting Program (VMSRP) on the FDA Medical Device Reporting (MDR) web page....more

Arnall Golden Gregory LLP

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under...

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AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more

Hogan Lovells

FDA proposes annual summary reporting requirements for Right to Try drug sponsors, manufacturers

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On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more

Hogan Lovells

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

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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

Hogan Lovells

CDRH's Voluntary Malfunction Summary Reporting Program

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On August 17, 2018, the Food and Drug Administration (FDA) released the Medical Device Voluntary Malfunction Summary Reporting Program (VMSRP) agreed between industry and the FDA as a part of the Medical Device User Fee...more

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