Medical Devices Pharmaceutical Industry Healthcare

News & Analysis as of

AdvaMed 2015 Highlights – Part One of Two

On October 5-7, 2015, the Advanced Medical Technology Association (“AdvaMed”) held its 40th Annual Meeting for the first time on the West Coast—San Diego, California. This year also signaled a change of AdvaMed’s membership...more

Amendments in Kazakhstan’s medicinal products registration system: new hope for rights holders

In January and June 2015 Kazakhstan’s legislation was amended in order to protect the interests of developers of new pharmaceuticals and apparatus used in healthcare....more

Four Clear Messages from Bristol Meyers Squibb FCPA Enforcement Action

The SEC’s FCPA enforcement action for $14.6 million against Bristol Meyers Squibb (“BMS”) in China provides a textbook example of how things can go wrong in China. For the compliance practitioner (as well as CEO and...more

Justice Department Recovers Nearly $6 Billion From False Claims Act Cases in 2014

The U.S. Department of Justice (DOJ) obtained a record $5.69 billion in settlements and judgments from civil cases involving fraud and false claims against the government in fiscal year 2014. This marks the first time the DOJ...more

MedPAC Convenes to Discuss Open Payments, Payment for Post-Acute Care, and Other Issues

On September 10-11, 2015, MedPAC held a meeting to discuss several issues related to the Medicare program, including (1) improving the Open Payments program, which makes public the payments from drug and device manufacturers...more

Drug and Device Companies May Soon Face Less Burdensome FDA Approval Process

On July 10, 2015, Congress passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344 to 77. The 352-page bill seeks to make the U.S. Food and Drug Administration (FDA) drug and device approval process less...more

Highway 61 Revisited-Tombstone Blues and Corporate Integrity Agreements

I conclude my tribute to my favorite Bob Dylan album, Highway 61 Revisited with a look at the most surreal song on the disc, Tombstone Blues. I want to use it to contrast the most excellent article that appears today as a...more

HHS Proposes Major Overhaul of the Common Rule

On September 8, 2015, the Department of Health and Human Services proposed significant revisions to the Federal Policy for the Protection of Human Subjects (“Common Rule”), the set of federal regulations governing the conduct...more

Key Digital Health Investment Trends to Watch

Our fourth annual Digital Health Summit brought together a select group of investors active in the digital health, life sciences, medical device, and healthcare industries for a one-day meeting to discuss the future of...more

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

Washington Healthcare Update

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

China’s State Council Announces Reform on the Drug and Device Approval System

China will launch new reforms of its current review and approval system for drugs and medical devices, announced by China’s State Council, in its August 18, 2015, circular Opinions Concerning the Reform of the Review and...more

Washington Healthcare Update

This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more

Medicare, Medicaid, and Enforcement Implications of the 21st Century Cures Act Recently Passed by the House

On July 10th, the U.S. House of Representatives passed the 21st Century Cures Act – medical innovation reform legislation that has been in the works for over a year – by a wide margin (344-77). As Ropes & Gray previously...more

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

Georgia Senator Introduces The Combination Product Regulatory Fairness Act of 2015

On July 17, 2015, Georgia’s U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a Senate bill entitled, “The Combination Product Regulatory Fairness Act of...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

21st Century Cures Act Passes House: Could Usher In Broad Reforms to Drug Approval Process

On Friday, July 10th the U.S. House voted overwhelmingly to streamline the approval process of prescription drugs and medical devices by the FDA. If passed in the Senate and signed by President Obama, the “21st Century Cures...more

Revised House 21st Century Cures Bill Released Ahead of House Vote

Later this week, the House of Representatives is expected to consider the H.R. 6, the 21st Century Cures Act. Ahead of the House vote, the House Rules Committee released a revised version of the bill with new funding offsets...more

FAS Russia official recommendations on the commercial policies of manufacturers of pharmaceuticals and medical devices holding a...

On June 30, 2015 on its official site FAS Russia published recommendations for entities holding a dominant position on pharmaceuticals markets and medical devices markets (hereinafter together “pharmaceutical companies”) to...more

DIA 2015 Provides Panels on All Types of FDA-Regulated Products with Many Opportunities for Insight and Interaction – Part Two of...

On the third day, the Center for Biologics Evaluation and Research (CBER) conducted its own Town Hall. CBER Director, Karen Midthun, explained how CBER works proactively to help develop new biological therapies. For example,...more

Health Alert (Australia) - June 15, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: New South Wales. O'Sullivan v Medical Council of New South Wales [2015] NSWCATAD 113 The New South Wales Civil and...more

Washington Healthcare Update

This Week: GOP Post-King Contingency Bills Released in Both the House and the Senate... House E&C Committee Draft LDT Bill – Creates FDA In Vitro Center, Sets Agency Review Timeline and Defines Risk Categories... CMS...more

21st Century Cures Act Passes House Committee

The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark...more

Is This The End of RICO?

The short answer is “no.” We are just borrowing a line from one of the original gangster movies, “Little Caesar,” which readers other than McConnell would most likely know from references in “The Sopranos,” if they know it...more

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