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New draft guidance on quality agreements: no passing the buck on CGMPs

  • Alston & Bird LLP
  • -
  • USA
  • -
  • June 3 2013

Last week, FDA released a draft guidance document entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements." The guidance

Medical device developments

  • Alston & Bird LLP
  • -
  • USA
  • -
  • March 4 2013

On February 25, 2013, the U.S. Food and Drug Administration (FDA) issued a proposed rule amending its regulations to update the standards for FDA

FDA issues a draft guidance for industry and FDA staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff.".

  • Alston & Bird LLP
  • -
  • USA
  • -
  • July 31 2012

On July 13, 2012, FDA issued a Draft Guidance for Industry and FDA Staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff."

FDA proposes unique device identification (UDI) system for medical devices

  • Alston & Bird LLP
  • -
  • USA
  • -
  • July 31 2012

On July 10, 2012, the U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register (77 Fed. Reg. 40736) to establish a unique device identification (UDI) system for medical devices

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FDA revisiting REMS draft guidance and overall policy in upcoming public meeting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