Manufacturers Pharmaceutical Industry

News & Analysis as of

Update on Health Canada's Modernization Makeover: Proposed Changes to Labelling Standards for Products Containing Acetaminophen

Health Canada is in the midst of a “modernization makeover.” The Agency is undertaking a multi-year, comprehensive review of its regulatory frameworks for health products and food. Among other things, modernization efforts...more

Antitrust Matters - September 2015

Antitrust investigations are no longer limited to a nation’s borders, or even to a region. Enforcers are more and more sharing information and coordinating their investigative efforts as they strive to uniformly enforce the...more

Manufacturing Outlook - July 2015 - 2015 Q3

Welcome to the 2015q3 Manufacturing Outlook report in partnership with DLA Piper. It has been an eventful summer in the world economy; while not quite four seasons in one day, we’ve seen the future of the eurozone on the...more

Red Notice Newsletter - August 2015

Welcome to the August 2015 edition of Red Notice, a publication of Akin Gump Strauss Hauer & Feld LLP. This month on the anticorruption front, the U.S. Department of Justice (DOJ) and the U.S. Securities and Exchange...more

European Commission Seeking Comments On Draft Text Laying Out The Safety Features To Appear On Pharmaceutical Packaging

On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human...more

NIST Guide Highlights Cybersecurity Considerations for Utilities and Manufacturing Companies

In 2013 alone, the U.S. Department of Homeland Security (DHS) and its Industrial Control Systems Cyber Emergency Response Team (ICS-CERT) responded to more than 256 cyber-incident reports—more than half of them in the energy...more

The Medicines Company v. Hospira - Preparation of validation batches by a contract manufacturer for FDA submission creates an...

On July 2, 2015, the Court of Appeals for the Federal Circuit held that a patent owner’s use of a contract manufacturer (CMO) to prepare validation batches of a drug formulation for submission to FDA created an invalidating...more

Medicinal Product Regulation and Product Liability in Australia: Overview

The Therapeutic Goods Act 1989 (Cth)(TG Act): - Provides a national framework for the regulation of medicinal products. - Provides a national system to control the quality, safety, efficacy and timely availability...more

ITC Section 337 Update - June 2015 #2

Second 100-Day ID Finds Complainant Has Standing In 949 Investigation – As mentioned in prior coverage, on March 12, 2015, the Commission issued a Notice of Investigation in Certain Audio Processing Hardware and Software,...more

The Continuing Evolution of the French Sunshine Act

Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals,...more

The Sixth Circuit Reins in the Government's Measure of False Claims Act Damages

Pharmaceutical and device companies, financial institutions, government contractors, oil and gas conglomerates, and other public and private entities continue to be in the crosshairs of aggressive federal government...more

Alabama Governor Signs Bill Quashing Innovator Liability Claims

On May 1, 2015, Alabama Governor Robert Bentley signed SB80, which expressly bars liability claims against manufacturers that did not design or make the product that a plaintiff actually ingested or used. While at first...more

Blog: CMS’ Annual Open Payments Report to Congress Highlights Some Key Areas to Watch

The Centers for Medicare & Medicaid Services (CMS) must submit an annual report to Congress in connection with the federal Sunshine law. ...more

Trade Agreements Act Compliance Activity Increasing at VA

Companies should include internal TAA compliance reviews in their overall manufacturing compliance programs. Every manufacturer of medical devices and pharmaceuticals that offers a product for sale to the federal...more

Successful Rule 9(b) Defense of False Claims Act Whistleblower Litigation

The lure of significant monetary awards continues to stimulate high-risk whistleblower actions under the False Claims Act (FCA), and these claims are increasingly common in the pharmaceutical and medical device industry. The...more

Open Payments/Sunshine Act Year Two: Guidance for Physicians

On June 30, 2015, the Centers for Medicare and Medicaid Services (CMS) will publish the first full-year report of payments to physicians from pharmaceutical and medical device manufacturers. Physicians who want to review...more

Brick By Brick, The Learned Intermediary Doctrine Paves A West Virginia Path

Back in November, we exulted over the pelvic mesh MDL judge’s resurrection of West Virginia’s learned intermediary doctrine. In Tyree v. Boston Scientific Corp., ___ F. Supp.3d ___, 2014 WL 5431993 (S.D.W. Va. Oct. 23,...more

Food for Thought: Mirabella v. Vital Pharmaceuticals, Inc.

In Mirabella v. Vital Pharmaceuticals, Inc., consumers sued the manufacturer of Redline Xtreme Energy Drink, alleging that the manufacturer concealed the dangerous side effects of the energy drink. Plaintiffs requested relief...more

FinCrimes Update - February 2015 Summary, Volume 2, Issue 2

NEW YORK BANK REGULATORY CONSIDERING CYBERSECURITY REGULATIONS, RANDOM AUDITS OF BANKS - On February 25, New York DFS Superintendent Benjamin Lawsky delivered remarks at Columbia Law School focusing on how state bank...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug,...more

The FCPA Year in Review: Twist and Shout (Part I of II)

We all like annual reviews and predictions for the upcoming year – it is a New Year’s rite of passage and one that brings perspective and a sense of order to our otherwise chaotic lives....more

CMS Publishes Guidance Regarding Reporting CME Payments Under Open Payments

On Monday, December 15, 2014, CMS published guidance regarding pharmaceutical and medical device manufacturers’ obligations under the Open Payments requirements to report payments they provide indirectly to U.S. physicians in...more

Ninth Circuit Holds California Can’t Double-Dip By Seeking Restitution for Citizens Bound By Class Settlement

In the wake of a nationwide class action settlement of litigation against a manufacturer of a test claimed to accurately predict the gender of a fetus, the State of California (“State”) brought an enforcement action against...more

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