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Results: 1-10 of 55

New draft guidance on quality agreements: no passing the buck on CGMPs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Last week, FDA released a draft guidance document entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."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 streamlines CGMP compliance for combination products
  • Alston & Bird LLP
  • USA
  • January 24 2013

On January 22, 2013, the U.S. Food and Drug Administration (FDA) published its final rule implementing current good manufacturing practice (CGMP


FDA acceptance policies on PMA and 510(k) submissions
  • Alston & Bird LLP
  • USA
  • January 14 2013

On December 31, 2012, FDA issued two guidance documents detailing the agency's approach to reviewing the completeness of medical device applications


Court ruling on stem cells
  • Alston & Bird LLP
  • USA
  • July 31 2012

A recent decision by the United States District Court for the District of Columbia touches on several FDA issues


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


FDA issues a draft guidance for industry and FDA staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff.".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On July 13, 2012, FDA issued a Draft Guidance for Industry and FDA Staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff."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-related issues in the OIG 2011 Work Plan
  • Alston & Bird LLP
  • USA
  • October 28 2010

The Office of Inspector General (OIG) recently released its Fiscal Year (FY) 2011 Work Plan


Off-label promotion enforcement update
  • Alston & Bird LLP
  • USA
  • October 28 2010

As if drug and device companies did not have enough to worry about in the wake of numerous "fraud and abuse" lawsuits brought by the government, FDA is now signaling greater emphasis on criminal prosecutions for off-label promotion


Health care reform
  • Alston & Bird LLP
  • USA
  • October 28 2010

September 23 marked the six-month anniversary of the enactment of health care reform