Manufacturers, Pharmaceutical | JD Supra Law News

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

Supreme Court Oral Argument in FTC v. Actavis

by Kevin E. Noonan | McDonnell Boehnen Hulbert & Berghoff LLP on 4/2/2013

The Supreme Court heard oral argument in Federal Trade Commission v. Actavis (the caption for what was Federal Trade Commission v. Watson Pharmaceuticals, Inc. in the 11th Circuit opinion below) last Monday, with Deputy...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

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

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

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

Weeks Defies Years of Jurisprudence, Allowing Innovator Liability for Generic Drugs

by Erin M. Bosman, James W. Huston, Julie Y. Park | Morrison & Foerster LLP on 1/18/2013

Last week the Alabama Supreme Court adopted brand-name manufacturer liability for a generic drug sold by another company, becoming the first state supreme court to do so. Wyeth, Inc. v. Weeks, No. 1101397 (Ala. Jan. 11,...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

Stakeholders Call for Final Sunshine Act Rule

by Mintz Levin - Health Law on 1/17/2013

On January 14, 2013, a group of stakeholders, including the AARP and the AFL-CIO, urged the Obama Administration to issue the long-awaited final rule (the “Final Rule”) implementing the Physician Payments Sunshine Act (the...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

Update on Federal and State Developments: Regulation of Financial Interactions between Health Care Providers and Pharmaceutical...

by Ropes & Gray LLP on 12/13/2012

Recent weeks have seen two significant developments with respect to federal and state laws regulating financial interactions between pharmaceutical and medical device companies and health care providers: (1) the Centers for...more

Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct: Final Amendments to Be Issued

by Wendy C. Goldstein, Natasha F. Thoren | Epstein Becker & Green, P.C. on 12/5/2012

On November 21, 2012, the Massachusetts Public Health Council approved final amendments to 105 Mass. Code Regs. 970.000, the Massachusetts Pharmaceutical and Medical Device Manufacturer Conduct Law ("Massachusetts Marketing...more

Massachusetts Relaxes Strict Ban on Gifts from Pharmaceutical and Medical Device Manufacturers to Physicians

by Jonathan E. Anderman, Jeffrey W. Mittleman, Ilenna J. Stein | Holland & Knight LLP on 7/12/2012

Governor Deval Patrick signed into law Massachusetts’ fiscal year 2013 budget on July 8, 2012. The budget includes amendments to the state’s Pharmaceutical and Medical Device Manufacturer Conduct Law, MGL ch. 111N. The...more

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