X hits on this document

81 views

0 shares

0 downloads

0 comments

21 / 35

FDA may also intensify its efforts to remove unapproved drugs from the market

  • In 2006, FDA announced an initiative to crack down on unapproved drugs

    • “Marketed Unapproved Drugs – Compliance Policy Guide,” June 2006

  • FDA estimates that there are several hundred unapproved active ingredients, which are used in thousands of prescription drugs

  • In late March, as part of this enforcement initiative, FDA sent Warning Letters to nine companies manufacturing unapproved narcotic drugs

    • FDA advised these companies that they were required to cease distribution of the products

    • Fearing a shortage of necessary opioid products, FDA adopted an interim plan to let certain drugs containing morphine sulfate temporarily stay on the market

  • In early April, FDA announced that it had obtained a permanent injunction against Neilgen Pharmaceuticals to prevent the company from manufacturing and distributing more than 50 unapproved drug products

© 2009 Hogan & Hartson LLP. All rights reserved.

21

Document info
Document views81
Page views80
Page last viewedTue Dec 06 17:12:30 UTC 2016
Pages35
Paragraphs407
Words3160

Comments