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DDMAC increasing focus on objections to prominence of risk information

  • Alston & Bird LLP
  • -
  • USA
  • -
  • February 28 2010

Since the new administration assumed office and filled political appointments at FDA, one new emphasis seems to be assuring the prominent display of risk information in drug and device advertising

Public meeting on radiation exposure

  • Alston & Bird LLP
  • -
  • USA
  • -
  • February 28 2010

On March 30-31, FDA will hold a public meeting to discuss steps that could be taken by manufacturers of devices used in computed tomography (CT) and fluoroscopy that would help reduce unnecessary patient exposure to ionizing radiation during CT and fluoroscopic procedures

Closing comment periods of note

  • Alston & Bird LLP
  • -
  • USA
  • -
  • February 28 2010

FTC is seeking comments on proposed self-regulatory guidelines submitted by i-SAFE, Inc. under the safe harbor provision of the Children's Online Privacy Protection Rule

DDMAC increasing use of untitled letters vs. warning letters

  • Alston & Bird LLP
  • -
  • USA
  • -
  • February 28 2010

In initial statements concerning the enforcement priorities of FDA, Commissioner Hamburg noted that enforcement letters would no longer be required to be reviewed by the Office of Chief Counsel (OCC), and that additional letters would be issued by FDA when corrections in response to warning letters were deemed sufficient by the agency