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Results:1-10 of 20

Mind your Xs and Zs: are these letters too common in pharmaceutical trademarks?
  • Foley Hoag LLP
  • USA
  • June 4 2013

An interesting debate recently occurred in the New England Journal of Medicine between a physician and the U.S. Food and Drug Administration (FDA)


First Circuit Affirms Judgment Against Generic Drug Manufacturer on plaintiff's design defect claim, holding
  • Foley Hoag LLP
  • USA
  • July 25 2012

In Bartlett v. Mutual Pharmaceutical Company, Inc., 678 F.3d 30 (1st Cir. May 2, 2012), plaintiff suffered toxic epidermal necrolysis after taking sulindac, a generic version of the non-steroidal anti-inflammatory drug Clinoril.


Massachusetts federal court holds FDA pre-market approval of medical device consisting of multiple components preempts state law claims alleging defective design of individual component
  • Foley Hoag LLP
  • USA
  • April 17 2012

In Duggan v. Medtronic, Inc., 2012 WL 45503 (D. Mass. Jan. 10, 2012), plaintiff, a diabetes mellitus patient, was injured when an allegedly defective insulin pump part of an insulin pump and continuous glucose monitoring system malfunctioned, causing her to suffer a hypoglycemic reaction.


FDA’s draft guidance on scientific considerations in demonstrating biosimilarity
  • Foley Hoag LLP
  • USA
  • February 10 2012

Yesterday, the U.S. Food and Drug Administration released three draft guidance documents designed to assist industry in developing biosimilars and implementing the new abbreviated biologics approval pathway under section 351(k) of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), signed into law in March 2010 as part of the Patient Protection and Affordable Care Act


Government strategies alert: FDA releases long-awaited draft guidances on biosimilar product development
  • Foley Hoag LLP
  • USA
  • February 9 2012

Today, the U.S. Food and Drug Administration (FDA) released three draft guidance documents designed to assist industry in developing biosimilars.


Massachusetts Federal District Court holds defense expert’s testimony on lack of causal link between drug and suicide attempts admissible
  • Foley Hoag LLP
  • USA
  • April 25 2011

In In re Neurontin Marketing and Sales Practices and Products Liability Litigation, 2011 WL 1048971 (D.Mass. Mar. 18, 2011), over one hundred individuals experienced behavioral disturbances, depression and ultimately suicidal actions, including completed suicide, after their doctors prescribed an anti-epileptic drug, gabapentin.


Massachusetts Federal District Court holds hospital not fraudulently joined in medical device suit, as warranty claim asserting hospital was product seller rather than service provider has reasonable basis
  • Foley Hoag LLP
  • USA
  • January 31 2011

Plaintiff in Phillips v. Medtronic, Inc., 2010 WL 4939997 (D. Mass. Dec. 1, 2010), developed inflammatory masses causing pain and loss of certain functions after hospital treatment that included the implantation of two intrathecal pain pumps.


FDA releases proposed medical device reforms
  • Foley Hoag LLP
  • USA
  • January 20 2011

In response to protracted public and political criticism of the Food and Drug Administration's (FDA or Agency) regulation and review of medical devices under the premarket notification, or 510(k), process, the FDA's Center for Devices and Radiological Health (CDRH or Center) yesterday released a set of proposed reforms to better "foster medical device innovation and assure the safety and effectiveness of medical technology."


FDA recommends actions to improve oversight of medical devices
  • Foley Hoag LLP
  • USA
  • August 5 2010

On Wednesday, August 4, 2010, the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) released for public comment two preliminary reports recommending steps to: (1) foster medical device innovation; (2) enhance regulatory predictability; and (3) improve patient safety.


Phase II of the FDA’s Transparency Initiative: the Transparency Task Force releases draft recommendations on FDA’s public disclosure policies
  • Foley Hoag LLP
  • USA
  • May 21 2010

In June 2009, Dr Margaret Hamburg, the newly appointed Commissioner of Food and Drugs, announced the Food and Drug Administration ("FDA" or "Agency") Transparency Initiative and created the FDA Transparency Task Force to carry out the Initiative.