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100 results found

Article

Baker & Hostetler LLP | USA | 25 Apr 2017

Capitol Hill Healthcare Update

Although House Republicans made progress on bridging ideological differences over how to replace the Affordable Care Act (ACA), GOP leaders say not to

Article

Haug Partners LLP | USA | 19 Jul 2016

CREATES Act of 2016: Bipartisan Bill Aimed at Curbing REMS Abuses

Congress passed the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) to give the U.S. Food and Drug Administration (“FDA”) new authority

Article

Jenner & Block LLP | USA | 13 May 2015

Drug safety labeling: generic versus branded

Under FDA regulations, generic drugs must be chemically equivalent, have the same active ingredients, and be bioequivalent to their branded

Article

Duane Morris LLP | USA | 23 Jun 2011

U.S. Supreme Court holds that state-law-based failure-to-warn claims are federally preempted against generic drug manufacturers

On June 23, 2011, the U.S. Supreme Court issued a decision in Pliva, Inc. v. Mensing,1 holding that state-law claims against generic drug manufacturers are federally preempted pursuant to the Supremacy Clause of the U.S. Constitution.

Article

Piper Alderman | Australia | 7 Jun 2011

Regulation and PBS pricing of biosimilar drugs

In this article, we examine the issues surrounding the regulation of biosimilar drugs in Australia, including pricing issues under the Pharmaceutical Benefits Scheme.

Article

Shook Hardy & Bacon LLP | USA | 7 Apr 2011

Adequacy of generic drug warnings on U.S. Supreme Court agenda

The U.S. Supreme Court is considering whether a generic drug maker can be held liable under state law for failing to include on its drug label safety information not yet used by name brand manufacturers or required by the Food and Drug Administration (FDA).

Article

Shook Hardy & Bacon LLP | USA | 31 Mar 2011

U.S. Supreme Court hears argument on generic drug labeling

The U.S. Supreme Court is considering whether a generic drug maker can be held liable under state law for failing to include on its drug label safety information not yet used by name brand manufacturers or required by the Food and Drug Administration (FDA). PLIVA, Inc. v. Mensing, No. 09-993 (U.S., oral argument, March 30, 2011).

Article

Piper Alderman | Australia | 11 Feb 2011

The ongoing confusion about the concept of interchangeability

The concept of "interchangeability" of medicines was first introduced in 1997 when the government introduced therapeutic groups, which grouped together drugs that were considered to be therapeutically interchangeable on the basis of having similar safety and efficacy profiles, and health outcomes.

Article

McMillan LLP | Canada | 7 Oct 2010

Innovator duty of care in the pharmaceutical industry

Does the inventor or "innovator" of a brand-name drug have a duty of care to the consumers of that drug's generic equivalent manufactured by a competitor?

Article

Sheppard Mullin Richter & Hampton LLP | USA, Ireland | 30 Aug 2010

User fees for generic drugs - what are the issues?

On August 9, 2010, the Food and Drug Administration ("FDA") published a notice announcing a public meeting to be held September 17, 2010, "to gather stakeholder input on the development of a generic drug user fee program."

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