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Life Sciences › Regulatory Requirements › Reporting Requirements

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

Akin Gump Strauss Hauer & Feld LLP

Improving the Safety and Security of Biological Research (Trump EO Tracker)

Akin Gump Strauss Hauer & Feld LLP on

This Executive Order establishes a policy of the United States to ensure that federally funded research benefits American citizens without jeopardizing national security, strength or prosperity. The order seeks to strengthen...more

Blake, Cassels & Graydon LLP

Health Canada Proposes Regulations to Mitigate Drug and Medical Device Shortages

Blake, Cassels & Graydon LLP on

Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of...more

Faegre Drinker Biddle & Reath LLP

FDA's Final Rule for Laboratory Developed Tests

Faegre Drinker Biddle & Reath LLP on

The FDA’s Webinar for Manufacturers and Other Interested Parties - The U.S. Food and Drug Administration (FDA) will host a webinar on February 25, 2025, from 2:00 p.m. EST to 3:00 p.m. EST, providing additional information...more

Hogan Lovells

MHRA publishes guidance on to new UK medical device post-market surveillance requirements

Hogan Lovells on

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...more

Hogan Lovells

FDA warns of “important” clinical trial protocol deviations

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The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...more

ArentFox Schiff

New Burdensome FDA Requirements Mandate Reporting Volumes of Almost All Drugs Produced Each Year

ArentFox Schiff on

On October 29, 2021, the FDA issued two Guidances that implement a new requirement of the federal Food, Drug, and Cosmetic Act (FDCA) that all registrants of drug establishments – both domestic and foreign – must file a...more

Hogan Lovells

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

Hogan Lovells on

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

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Tuesday's Report: FDA...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: CFIUS reporting obligations

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Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more

Troutman Pepper Locke

Court Rejects CMS's Attempt to Broaden False Claims Act Liability in Medicare Overpayment Rule

Troutman Pepper Locke on

The U.S. District Court for the District of Columbia handed down a major victory to Medicare Advantage issuers on September 7, 2018, vacating a 2014 CMS regulation relating to Medicare Advantage overpayments. ...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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