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Food and Drug Administration (FDA) Young Lawyers

Pierce Atwood LLP

In a Groundbreaking Decision, Third Circuit Provides Framework for Evaluating Numerosity

Pierce Atwood LLP on

One of the least disputed elements of class certification is Rule 23(a)(1) numerosity, and so there is relatively little analysis from the courts about it. Last month, however, a divided panel of the Third Circuit provided a...more

Fish & Richardson

Short-Sellers Partnering with Hackers: Exploiting Cybersecurity Fears for Short-Term Profit

Fish & Richardson on

A research report released last week on the supposed cyber vulnerabilities of St. Jude Medical’s devices not only jeopardizes a pending $25 billion acquisition of the company by Abbott Laboratories, it opens a worrisome new...more

BakerHostetler

2016 Mid-Year Securities Litigation and Enforcement Highlights

BakerHostetler on

Welcome to the 2016 Mid-Year Report From the BakerHostetler Securities Litigation and Regulatory Enforcement Practice Team. The purpose is to provide a periodic survey, apart from our team Executive Alerts, on matters...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, July 2016

TSCA/FIFRA/IRIS/NTP/TRI - EPA Launches Advisory Panels: On June 15, 2016, the U.S. Environmental Protection Agency (EPA) launched two advisory panels designed to facilitate small businesses to provide feedback to EPA...more

Kelley Drye & Warren LLP

FDA Targets CBD Products, Claims Made in Social Media

Last February, FDA issued three warning letters to companies marketing cannabidiol (CBD) products as dietary supplements. FDA reviewed the companies’ websites and concluded that claims that CBD products could treat...more

BakerHostetler

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA and Antitrust Terrain

BakerHostetler on

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of...more

JD Supra Perspectives

Hacking Your Health: For Healthcare Providers, Risk Analysis Must Be Ongoing

JD Supra Perspectives on

Healthcare providers would be wise to keep in mind that if a patient is harmed by a hacked medical device, Exhibit A in the negligence suit against them may be that provider’s risk analysis, or lack thereof....more

Cozen O'Connor

Harsh Words for KIND Bars

Cozen O'Connor on

Kind, LLC received a rude awakening from the FDA when it notified the popular snack-maker that it was violating numerous federal regulations by allegedly misbranding four popular products. Kind is known for its widely-popular...more

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