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Results: 1-10 of 16

Window closing for comments on FDA transparency proposals

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 30 2010

The public comment period soon will end on 21 draft proposals FDA issued regarding its policy on the public disclosure of information in its possession (as weighed against the public interest in maintaining confidentiality of information

Policy & Hill update

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 30 2010

Since the passage of health care reform, attention within HHS has turned to implementation

OIG issues updated recommendations on FDA oversight of foreign clinical trials

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 30 2010

In September 2001, the Office of Inspector General (OIG) issued a report on "The Globalization of Clinical Trials: A Growing Challenge in Protecting Human Subjects" that detailed the dramatic increase in foreign clinical trials of drug products

FDA revisiting REMS draft guidance and overall policy in upcoming public meeting

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 30 2010

The agency recently announced an upcoming, two-day public meeting July 27-28 to solicit stakeholder feedback on the issues and challenges associated with the development and implementation of risk evaluation and mitigation strategies (REMS) for drugs and biologics

FDA proposes standards for major statements in DTC advertising

  • Alston & Bird LLP
  • -
  • USA
  • -
  • April 16 2010

FDA recently issued a proposed rule to implement the provision of the Food and Drug Administration Amendments Act (FDAAA) of 2007 requiring that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous and neutral manner

Periods of note

  • Alston & Bird LLP
  • -
  • USA
  • -
  • April 16 2010

Following its recent public meeting, the Food Safety and Inspection Service (FSIS) is seeking comments on ways to improve Agency procedures for identifying product that may be positive for E. coli O157:H7

Food safety reform

  • Alston & Bird LLP
  • -
  • USA
  • -
  • April 16 2010

The Office of Inspector General (OIGHHS) recently released a report detailing its review of FDA inspections of domestic food facilities

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

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