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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New draft guidance on quality agreements: no passing the buck on CGMPs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Last week, FDA released a draft guidance document entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements."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FDA issues a draft guidance for industry and FDA staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff.".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On July 13, 2012, FDA issued a Draft Guidance for Industry and FDA Staff entitled "Medical Devices: The Pre-Submission Program and Meetings with FDA Staff."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


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

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


The future of medical product approvals: parallel review by FDA and CMS?
  • Alston & Bird LLP
  • USA
  • October 28 2010

Last month, FDA and the Centers for Medicare and Medicaid Services (CMS) issued a Federal Register notice soliciting comments on a proposal to establish a process for the parallel review of drugs and devices for FDA marketing approval or clearance and CMS national coverage determinations (NCDs


FDA issues new guidance on research not requiring an IND
  • Alston & Bird LLP
  • USA
  • October 28 2010

In October, FDA issued a draft guidance entitled "Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can be Conducted Without an IND."