Medical Devices, Pharmaceutical

China Life Sciences Health Industry Client Briefing – April 2013 (May 15, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 5/15/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Drugs - Approval of Innovative Drugs and Key Sector Generic Drugs to be Expedited (Shanghai Securities Journal 2013-04-23): Given the...more

Capital Infusion - May 2013: Deal Spotlight: Patton Boggs Advises on Innovative Health Care Transaction

by Adam Connatser, Jon Finger, Rani Hauth Guerra, J. Atwood Jeter, David McLean | Patton Boggs LLP on 5/13/2013

Patton Boggs recently advised Satori Capital, a Dallas-based private equity firm, on its acquisition of Longhorn Health Solutions, Inc. Longhorn is headquartered in Austin, Texas and is a leading direct-to-home provider of...more

China Life Sciences Health Industry Client Briefing – March 2013 (April 26, 2013)

by Vicki Lung, Gordon B. Schatz, Katherine Yang, Amy Yin | Reed Smith on 4/29/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - ..Medical Devices - CFDA Seeks Public Comment on Special Approval Procedures for Innovative Medical Devices: China Food and Drug...more

Focus on Health Care Firms in FCPA Investigations

by Doreen Edelman | Baker, Donelson, Bearman, Caldwell &... on 4/10/2013

I am seeing a lot of interest from health care clients regarding the Foreign Corrupt Practices Act (FCPA). I usually stay away from this topic because so many others cover it in detail. However, I want to point out that in...more

Thoughts on Regulatory Constraints of Business Models

by Seth Mailhot | Sheppard Mullin Richter & Hampton LLP on 4/8/2013

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no...more

Getting Ready For The Physician Payment ‘Sunshine’ Rule

by Kathleen Howard, Joel R. Levin, Charles Mulaney, Jerica L. Peters | Perkins Coie on 3/22/2013

Originally Published in BNA Bloomberg, Medical Devices Law & Industry Report on March 20, 2013. On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations for...more

Here Comes the Sun: What You Need to Know about the Sunshine Act and Its Implementing Rules

by Edward Buthusiem, Cheray Lynch Sieminski | Berkeley Research Group, LLC on 3/20/2013

After years of deliberation, the Center for Medicare & Medicaid Services (CMS) published its long-awaited regulations to implement the specific requirements of the Physician Payment Sunshine Act (Sunshine) on February 1,...more

ProPublica's "Dollars for Docs": Will The Physician Payments Sunshine Provisions Clear The Haze?

by Robert Radick | Morvillo Abramowitz Grand Iason & Anello P.C.... on 3/20/2013

On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-delayed final rule that is intended to implement the Physician Payments Sunshine provisions that were included in the Patient...more

CMS Issues Rules On Physician Payments Sunshine Act

by Michael Volkov on 3/15/2013

People like to think they have it the hardest in life. I call it the competition among victims. If you are in the healthcare industry and fall under the Physician Payments regulations, then I think you are on your way to...more

China Life Sciences Health Industry Client Briefing – February 2013 (March 11, 2013)

by Vicki Lung, Mao Rong, Gordon B. Schatz, John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 3/12/2013

In This Issue: New Drug GSP Issued: Supervision on Drug Distribution to be Enhanced (China Securities Journal 2013-02-20) – February 20, 2013; China to Encourage Innovative Drug Development (Xinhua News Agency...more

Ninth Circuit Off-Label Marketing Decision Suggests More Prosecutions Will Be Coming

by David Douglass | Sheppard Mullin Richter & Hampton LLP on 3/8/2013

The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision. Last December, the pharmaceutical and...more

Final Sunshine Act Arrives: Now the Hard Part

by Michele L. Buenafe, Jonathan Havens, Kathleen McDermott, Rebecca Osowski, Albert Shay | Morgan Lewis on 3/8/2013

The Centers for Medicare and Medicaid Services (CMS) issued the final regulations on the U.S. Sunshine Act on February 8, 2013. Transparency Reports and Reporting of Physician Ownership or Investment Interests, 78 Fed. Reg....more

Physician Payment Sunshine Act Final Rule Released

by Thomas Donohoe, Lauren Groebe, Lindsay Kessler, Matthew Murer | Polsinelli on 3/7/2013

In This Issue: - Interpretation and Clarification of Key Definitions ..Applicable Manufacturers ..Applicable GPOs ..Covered Drug, Device, Biological or Medical Supply ..Covered Recipients ...more

Mirena IUD Lawsuit Consolidation Opposed by Bayer

by Audet & Partners, LLP on 3/6/2013

Bayer Healthcare Pharmaceuticals has taken a position opposing consolidation of legal actions brought against the medical device manufacturer for the Mirena IUD that can only be described as schizophrenic. Bayer opposed the...more

The Sunshine Physician Payment Final Rule Overview and Analysis

by Nancy Bonifant, Elizabeth Carder-Thompson, Katie Pawlitz | Reed Smith on 3/6/2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released the long-awaited Final Rule (Rule) to implement the “Sunshine” provisions of the Affordable...more

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

by Frederick Ball, Elinor Hart, Michael A. Swit | Duane Morris LLP on 3/6/2013

On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more

Vaginal Mesh Damages Against Johnson & Johnson Exceed $11 Million

by Audet & Partners, LLP on 3/5/2013

The first jury verdict against Johnson and Johnson (J&J)’s Ethicon subsidiary has resulted in a powerful statement regarding the pharmaceutical company’s lack of adequate warnings of the health risks posed by the transvaginal...more

Product Liability Annual Review -- 2012

by Morrison & Foerster LLP on 3/1/2013

In This Issue: Letter from Chair; Key Practice Highlights; Aviation; Consumer Products and Toxic Torts; Pharmaceutical Products and Medical Devices; Awards + Rankings; Publications; Key Contacts. Excerpt from...more

Let the Collection and Reporting Begin: CMS Publishes Final Sunshine Act Regulations

by Tom Crane, Brian P. Dunphy, Karen S. Lovitch, Kate Stewart | Mintz Levin - Health Law on 2/4/2013

The long-awaited final rule (the Final Rule) implementing the Physician Payments Sunshine Act (Sunshine Act) has arrived at the Federal Register. It amends key definitions and adds new terms; retains broad reporting...more

China Life Sciences Health Industry Client Briefing - December 2012 (January 18, 2013)

by Vicki Lung, Mao Rong, Gordon B. Schatz, John Tan, May Ling Wong, Jay J. Yan, Katherine Yang | Reed Smith on 1/24/2013

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - News & Regulations: ..Industry Calls for Reform of Lagging Drug Review System (Global Times 2012-12-02) – December 3, 2012...more

Chinese MOH Announced Centralized Procurement of High Value Medical Consumables

by Katherine Wang | Ropes & Gray LLP on 1/18/2013

On December 17, 2012, the Ministry of Health (“MOH”) issued the Tentative Guidelines for Centralized Procurement of High Value Medical Consumables (the “Guidelines”) with immediate effect, with an aim to control health care...more

Getting the Best Medical Care: a Newsletter from Patrick Malone - January 2013

by Patrick Malone & Associates P.C. | DC Injury... on 1/11/2013

In This Issue: - Six Things to Think About as Technology Advances - For More Information - Recent Health Care News You Should Know About - Check Out Our Previous Tips - Deep Thoughts for the New Year: Ethical...more

Strict Products Liability Claims Based On Design Defect Are Inapplicable To Implanted Medical Devices That Are Available Only...

by CMCP - California Minority Counsel Program on 12/21/2012

A recent California Court of Appeal decision out of the Second District has provided further clarity to the scope of California products liability law by reasserting the general rule that precludes strict liability for design...more

IRS Releases Final Rule on Medical Device Tax

by King & Spalding on 12/18/2012

Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

by Mao Rong, Gordon B. Schatz, Hugh T. Scogin , Jr., John Tan, May Ling Wong, Jay J. Yan, Katherine Yang, Amy Yin | Reed Smith on 12/17/2012

In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more

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Medical Devices › Pharmaceutical