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December 19, 2013 |

Unapproved Opinions

Opinions not approved for publication.
61 minute read
May 29, 2006 |

Decision summaries from the NLJ

Aviation fuel isn't motor vehicle fuel under law- and other recent decision summaries from The National Law Journal.
10 minute read
March 14, 2011 |

FDA taking new look at medical-device review process

The agency may end up applying 'least burdensome provisions' more narrowly than before.
7 minute read
Demahy v. Actavis, Inc.
Publication Date: 2010-01-12
Practice Area: Products Liability
Industry:
Court: 5th Cir.
Judge: Patrick E. Higginbotham, Circuit Judge
Attorneys:
For plaintiff:
For defendant:
Case number: 08-31204

Before KING, HIGGINBOTHAM, and CLEMENT, Circuit Judges.This case presents one issue on appeal: whether the federal regulatory regime governing pharmaceuticals preempts state-law failure-to-warn cla

Law Journal Press | Digital Book America Invents Act (AIA) Handbook: A Guide to the Patent Law Reform of 2011, The, 2015 Edition Authors: Mary Anthony Merchant View this Book

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December 14, 2007 |

The New Labeling Law

This article describes the Food & Drug Administration Amendments Act of 2007, and discusses its significance to the pharmaceutical industry.
8 minute read
October 04, 2005 |

Science on the Edge

Sonia E. Miller, an attorney in private practice in New York and Washington, D.C., writes that nanotechnology is expected to generate revolutionary contributions to cancer detection, treatment and prevention, but because of its multidisciplinary nature, FDA classification and "prior art" patent searches are issues of concern, as is potential product liability arising from this still young area of research.
7 minute read
January 23, 2012 |

FDA Issues New Procedure for Submissions

Bethany Hills, Vice-Chair of the Food, Drug and Cosmetic Law Section, reviews the new FDA standard operating procedure that essentially requires that individual reviewers obtain "concurrence from appropriate management?before taking any action" with regard to requesting data that differs from other premarket submissions for the device type or previous communications with a manufacturer.
3 minute read
September 20, 2005 |

Is FDA's New Chief Counsel a Change in Name Only?

The FDA's new chief counsel, Sheldon Bradshaw, has so far escaped the scrutiny faced by his predecessor, Daniel Troy, who was pilloried for his close ties to the drug industry. But Troy's controversial legal policies remain very much in force. Like Troy, Bradshaw offers one-on-one meetings with companies regulated by the agency, has kept low the number of warnings given about violations of regulations, and, perhaps most notably, continues to intervene on drug companies' behalf in private civil suits.
10 minute read
September 19, 2005 |

At FDA, Change In Name Only

Sheldon Bradshaw arrived at the Food and Drug Administration without the baggage lugged around by his predecessor. However, the previous chief counsel's controversial legal policies remain in force at the agency.
10 minute read

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