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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
April 05, 2005 |

Regulating Nanotechnology

Sonia E. Miller, an attorney and founder and president of the Converging Technologies Bar Association, writes that nanotechnology, the buzzword of the 21st century, stirs continual debate around the issue of regulation. Two diverse schools of thought prevail.
8 minute read
April 07, 2005 |

Regulating Nanotechnology

As nanotechnology continues to stir debate, two diverse schools of thought prevail, says attorney Sonia E. Miller. U.S. regulators maintain that the unique size and properties of nanoscale materials do not warrant new laws. But some advocacy groups and non-government organizations say that simply tinkering with existing regulations will not address the social, health, environmental and economic concerns posed by nanotechnologies. These differences in opinion pervade international discourse.
8 minute read
April 07, 2005 |

Regulating Nanotechnology

As nanotechnology continues to stir debate, two diverse schools of thought prevail, says attorney Sonia E. Miller. U.S. regulators maintain that the unique size and properties of nanoscale materials do not warrant new laws. But some advocacy groups and non-government organizations say that simply tinkering with existing regulations will not address the social, health, environmental and economic concerns posed by nanotechnologies. These differences in opinion pervade international discourse.
8 minute read
October 13, 2005 |

Nanomedicine Raises Intellectual Property Concerns

The term "nano" has come to signify quick, tiny and cutting-edge. Similarly, nanotechnology represents science at the cutting edge, as it converges with biology, medicine and information technology. One area of research expected to generate revolutionary contributions is cancer nanotechnology. The application of convergent technologies to cancer is creating more effective methods of detection, treatment and prevention, as well as raising a host of intellectual property issues.
7 minute read
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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April 22, 2003 |

NEWS FROM THE FDA

4 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
February 05, 2002 |

Top Plaintiffs' Verdicts

A look at the top plaintiffs' verdicts of the year 2001, from asbestos to tortious interference.
76 minute read
March 14, 2011 |

Learning from our neighbors about regulation of biosimilar drugs

The experience of foreign regulatory agencies may play an important role as the FDA develops its own standards.
6 minute read
August 08, 2000 |

Lobbying for the Enemy

It's a relatively rare occurrence -- a regulated industry lobbying on behalf of its regulators. But when the business community lobbied for the FDA winning an extra $3.2 million for the agency, it also helped itself. With more staff to review applications, drugs should move into the market at a faster pace.
6 minute read

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