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Results: 1-10 of 38

FDA releases "Purple Book," including biosimilar products

  • Reed Smith LLP
  • -
  • USA
  • -
  • October 6 2014

The FDA's new "Purple Book" lists biological products licensed by FDA under the Public Health Service Act (the PHS Act). The publication includes

FDA meeting on biomarker development (Sept. 5)

  • Reed Smith LLP
  • -
  • USA
  • -
  • July 22 2014

On September 5, 2014, the FDA is holding a public meeting at the Washington Plaza Hotel, in Washington DC, to discuss current scientific and

FDA releases drugdevice industry social media guidance documents

  • Reed Smith LLP
  • -
  • USA
  • -
  • June 23 2014

The FDA released two draft social media guidance documents last week, describing how manufacturers, packers and distributors of prescription drugs

FDA to hold workshop on accessible standardized medical device labeling (April 29-30)

  • Reed Smith LLP
  • -
  • USA
  • -
  • January 11 2013

On April 29 and 30, 2013, the Food and Drug Administration (FDA) is hosting a public workshop on "Accessible Standardized Medical Device Labeling." The

GAO flags concerns about implantable medical device information security

  • Reed Smith LLP
  • -
  • USA
  • -
  • October 16 2012

A recent GAO report warns of information security risks such as unauthorized changes of device settings resulting from a lack of appropriate access controls -- associated with the growing use of wireless technology in certain active implantable medical devices (e.g., implantable cardioverter defibrillators and insulin pumps

OIG examines dietary supplement claims, registration with FDA

  • Reed Smith LLP
  • -
  • USA
  • -
  • October 16 2012

The OIG has released two reports focusing on dietary supplements, one examining labeling claims and the other reviewing the FDA’s ability to identify and contact manufacturers in a public health emergency

OIG calls on CMS to implement safeguards for the Medicare prostheticsorthotics benefit

  • Reed Smith LLP
  • -
  • USA
  • -
  • October 15 2012

The OIG has issued a report, “CMS Has Not Promulgated Regulations To Establish Payment Requirements for Prosthetics and Custom-Fabricated Orthotics,” that calls on CMS to implement long-delayed statutory requirements and to better enforce regulatory standards for supplier documentation

House, Senate approve FDA User FeeDrug Safety Bills

  • Reed Smith LLP
  • -
  • USA
  • -
  • May 31 2012

On May 30, 2012, the House of Representatives voted 387-5 to approve H.R. 5651, the Food and Drug Administration Reform Act

FDA reports on post-approval drug safety monitoring

  • Reed Smith LLP
  • -
  • USA
  • -
  • May 11 2012

According to an April 24, 2012 Center for Drug Evaluation and Research (CDER) report, a strengthened and modernized post-market drug safety program has resulted in a substantial improvement in FDA’s oversight of drugs once they reach the American public

FDA issues final rule on sterility testing of biological products

  • Reed Smith LLP
  • -
  • USA
  • -
  • May 11 2012

On May 3, 2012 the FDA issued its final rule on sterility testing, amending the requirements for most licensed biological products effective June 4, 2012