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Results: 1-10 of 184

Pharmaceutical & medical device regulatory update, issue 10

  • Jones Day
  • -
  • USA
  • -
  • July 18 2014

Armed with new authority granted by the Drug Quality and Security Act ("DQSA"), FDA is increasingly using its regulatory powers to enhance oversight

Pharmaceutical & medical device regulatory update, issue 9

  • Jones Day
  • -
  • USA
  • -
  • July 1 2014

In a draft guidance issued on June 20, FDA announced it does not intend to enforce compliance with regulations governing medical device data systems

FDA finalizes guidance document on Expedited Programs for Serious Conditions

  • Jones Day
  • -
  • USA
  • -
  • June 27 2014

On May 30, 2014, FDA finalized its Guidance for Industry: Expedited Programs for Serious Conditions - Drugs and Biologics. The draft guidance

Time running out to file comments on OIG proposed rulemaking that gives OIG limitless time to exclude providers

  • Jones Day
  • -
  • USA
  • -
  • June 26 2014

Statutes of limitation serve an essential purpose in ensuring that claims are timely pursued before evidence becomes stale, and that parties can

American Medical Association offers new telemedicine recommendations

  • Jones Day
  • -
  • USA
  • -
  • June 16 2014

During this week's annual meeting, the American Medical Association's ("AMA") House of Delegates approved its Council on Medical Service's report

Physician-owned distributorships: government takes action

  • Jones Day
  • -
  • USA
  • -
  • June 10 2014

On February 7, the Department of Justice filed an action in the Eastern District of Michigan seeking to enforce a Civil Investigative Demand (CID

Deciding whether to play or pay under the Affordable Care Act - 2014 updates

  • Jones Day
  • -
  • USA
  • -
  • June 6 2014

The Patient Protection and Affordable Care Act (the "ACA") added a new Section 4980H to the Internal Revenue Code of 1986, as amended, which

Pharmaceutical & medical device regulatory update, issue 7

  • Jones Day
  • -
  • USA
  • -
  • June 5 2014

On May 29, FDA finalized an order that requires once-exempt tanning beds and booths, officially known in FDA regulations as "sunlamp products," to

Food, dietary supplement & cosmetics regulatory update, issue 6

  • Jones Day
  • -
  • USA
  • -
  • May 28 2014

FDA will hold a public meeting in late June on the proposed food labeling rules to revise Nutrition and Supplement Facts labels and the Serving Sizes