Tag Archives: Drug Manufacturer

Reed Smith hosts July 16 life sciences virtual roundtable on “Deal making in a post-COVID world”

While the life sciences sector has proven more resilient than most, COVID-19 has undoubtedly caused a dramatic slowdown in deal activity globally across industries. Please join Reed Smith and a panel of strategic, private equity, and venture capital leading deal makers for an engaging discussion on the impact COVID-19 has had on deal making in … Continue Reading

Reed Smith’s Kevin Madagan and Julia Lake to Present an Advertising and Promotion Primer at DIA’s Regulatory Affairs Conference

Reed Smith partner Kevin Madagan and associate Julia Lake will return for a second year to help lead a four-hour “Ad Promo Primer” at the Drug Information Association (DIA)’s “Advertising and Promotion Regulatory Affairs Conference,” which will be held virtually May 18-20, 2020. In addition, Kevin, a member of this year’s planning committee, will be leading … Continue Reading

Join us for a webinar on the changing regulatory landscape of promotion: Drug/biologic advertising in the Trump era and beyond

As a part of our FDA Series, Reed Smith will be hosting an upcoming webinar, “The changing regulatory landscape of promotion: Drug/biologic advertising in the Trump era and beyond” on Thursday, September 19, 2019 at 2:00 PM ET. This program will discuss promotional enforcement activity under the Trump Administration and how recent technological, demographic, and … Continue Reading

Little-Known Trap in U.K. Intellectual Property Litigation Could Cost Successful Plaintiffs: What Life Sciences Companies Need to Know

Did you know the U.K. patents system penalizes a failure to record a patent transaction at the Patent Office by depriving a successful plaintiff of its entitlement to recover its full legal costs in any subsequent infringement litigation on that patent? It’s a little-known trap for the unwary, and the subject of our London partner … Continue Reading

Upcoming Free Educational Opportunities for Life Sciences Clients

As the life sciences industry continues to undergo significant changes, Reed Smith is committed to offering high quality, free educational opportunities for its pharmaceutical, medical device, and biotechnology clients. We thus are pleased to shared two upcoming opportunities with you. First, because the new import tariffs proposed by the current administration could significantly affect life … Continue Reading

Upcoming Free Ethics CLE Webinar: “Privilege Protection: Tips for Working with Media Consultants Without Jeopardizing the Attorney-Client Privilege”

Involving any outside consultant in the attorney-client relationship gives rise to risks to the attorney-client privilege. Yet when a PR crisis erupts, good communications advice is essential, and a company’s media strategy can determine whether it is the subject of thoughtful, balanced articles or a maelstrom of misleading headlines – and whether unfair publicity infects … Continue Reading

Upcoming Free CLE Webinar: “Multidistrict Litigation: What to Expect from JPML Consolidation Through Trial”

With more than half of all cases pending in the federal courts now docketed in multidistrict litigations (MDLs), pharmaceutical and medical device companies facing large-scale litigation should expect to find themselves before the Judicial Panel on Multidistrict Litigation (JPML) with an MDL on the horizon. That’s why Melissa Geist and Jennifer Eppensteiner are pleased to … Continue Reading

FDA Clarifies Trading Partners Under the DSCSA

The Federal Food and Drug Administration (“FDA”) recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the Drug Supply Chain Security Act (“DSCSA”). The DSCSA establishes product tracing, licensure, reporting, and other requirements for certain trading partners … Continue Reading

Join Us for a Free CLE Webinar on Social Media Issues for Pharmaceutical, Medical Device Companies

The Reed Smith Life Sciences Health Industry Group will be hosting a free CLE webinar, “Social Media Issues for Pharmaceutical and Medical Device Companies,” on November 2, 2016 at 12 p.m. ET. Social media can be a great way to engage with consumers and build your brand. For pharmaceutical and medical device companies, however, it … Continue Reading

Reed Smith Attorneys to Speak at DRI’s November 10th Government Enforcement and Corporate Compliance Seminar

Reed Smith attorneys Jason Casell and Steve Miller will be moderating and presenting respectively on the “Pharmaceutical and Medical Devices Industries Update” panel on November 10, 2016 at DRI’s Government Enforcement and Corporate Compliance Seminar. This panel will examine recent government enforcement activities and legal decisions that might shape investigations, litigation, and resolutions of government … Continue Reading

New Edition of Singapore International Arbitration Centre Rules to Come into Effect Shortly

Pharmaceutical and medical device manufacturers are increasingly finding themselves resolving disputes through international arbitration. After London, Singapore is now arguably the second most important arbitration center in the world, meaning the Singapore International Arbitration Centre’s (SIAC) new arbitration rules, which were due to come into effect on June 1, 2016, but will now come into … Continue Reading

Upcoming Reed Smith Webinar on Recent Personal Jurisdiction Rulings, What Corporations Can Learn from Them

The Reed Smith Life Sciences Health Industry Group will be hosting an upcoming CLE webinar “Personal Jurisdiction: What Bauman Does and Doesn’t Mean, the Other Side’s Response, and Why Corporations Should Care” on June 14, 2016 at 12 p.m. ET. Reed Smith presenters Jim Beck and Steve McConnell will be discussing how plaintiffs’ lawyers are … Continue Reading

Is Your SEM FDA Compliant? New Google SEM Policy Forces Pharmaceutical Industry to Adjust Paid Search Advertisements

Upcoming changes to Google AdWords’ ad formats will have a significant impact on pharmaceutical companies that engage in paid search advertising. In a letter to its major media agencies last month, Google announced that it will be removing two of its popular pharmaceutical advertising units. Black Box Ad Format On July 20, 2015, Google’s Black … Continue Reading

New Jersey’s DTC Advertising Exception to the Learned Intermediary Doctrine

When the New Jersey Supreme Court ruled in Perez v. Wyeth Lab, Inc. that if pharmaceutical manufacturer directly markets to consumers, the learned intermediary doctrine does not apply, it was deemed a “revolutionary,” decision. However, since the ruling, every New Jersey court which has confronted this issue has found that the DTC exception did not … Continue Reading

Alameda Drug Disposal Ordinance: Supreme Court Denies Petition for Writ

The United States Supreme Court has declined to hear a challenge to the Alameda County Drug Disposal Ordinance (“Ordinance”) brought by three pharmaceutical trade organizations.  The Court’s decision leaves in force the Ninth Circuit decision, which found that the Ordinance, requiring pharmaceutical manufacturers to fund drug take-back programs in the county, did not interfere with … Continue Reading

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, pharmaceutical and medical device manufacturers, and government officials, among others. As Reed Smith partner Daniel Kadar points out in “The French Sunshine … Continue Reading

21st Century Cures Markup Underway; Offsets Released

Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, … Continue Reading

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

On May 5, the Office of Inspector General (OIG) issued a report entitled "FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs" in response to a Congressional request expressing concerns about the safety and quality of generic drugs produced by manufacturers outside the United States. The OIG report contains an analysis of FDA's inspections of generic drug manufacturers over the past several years, and provides several recommendations for the FDA going forward.… Continue Reading
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