We use cookies to customise content for your subscription and for analytics.
If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.
In cooperation with Association of Corporate Counsel
  Request new password

Search results

Order by most recent / most popular / relevance

Results: 1-6 of 6

Summary bioequivalence data for abbreviated new drug applications

  • Reed Smith LLP
  • -
  • USA
  • -
  • April 23 2009

The Food and Drug Administration (FDA) has released draft guidance for industry entitled "Submission of Summary Bioequivalence Data for ANDAs."

Gene patents & licensing practices

  • Reed Smith LLP
  • -
  • USA
  • -
  • April 6 2009

The HHS Secretary's Advisory Committee on Genetics, Health, and Society has published a notice soliciting comments on a draft report on "Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests

Generic drug competition

  • Reed Smith LLP
  • -
  • USA
  • -
  • October 30 2009

The Senate Judiciary Committee has approved S. 369, the Preserve Access to Affordable Generics Act, which generally would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market

Waxman urges President Obama to use pathway for biogenerics now

  • Reed Smith LLP
  • -
  • USA
  • -
  • June 9 2009

On June 8, 2009, House Energy and Commerce Committee Chairman Henry Waxman wrote to President Obama asking "the Administration to consider what steps can be taken under existing authority to prepare and even begin to use a pathway for generic biologics."

FTC report on "authorized generic" drugs

  • Reed Smith LLP
  • -
  • USA
  • -
  • July 7 2009

The Federal Trade Commission (FTC) has issued an interim report on the impact of authorized generic drugs on competition in the prescription drug marketplace

FTC report on drug company "pay-for-delay" agreements

  • Reed Smith LLP
  • -
  • USA
  • -
  • January 27 2010

The Federal Trade Commission has released a "staff study" entitled "Pay for Delay: How Drug Company Pay-Offs Cost Consumers Billions."