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FDA authorizes 23andMe to market DTC genetic carrier test, and announces plan to exempt certain carrier screening testing from premarket review

  • Hogan Lovells
  • -
  • USA
  • -
  • February 23 2015

On February 19, 2015, the U.S. Food and Drug Administration (FDA or the Agency) authorized for marketing 23andMe's Bloom Syndrome carrier test, a

FDA publishes draft guidances and memorandum of understanding on drug compounding and repackaging

  • Hogan Lovells
  • -
  • USA
  • -
  • February 23 2015

On February 13, 2015, FDA issued four draft guidance documents and a draft memorandum of understanding (MOU) regarding the compounding of drug and

Less is more in FDA’s eyes: FDA’s revised draft guidance on disclosing risk information

  • Hogan Lovells
  • -
  • USA
  • -
  • February 11 2015

On Monday, February 9, 2015, the Food and Drug Administration (FDA) published a revised draft guidance addressing disclosure of risk information

First custom device annual report due March 31, 2015

  • Hogan Lovells
  • -
  • USA
  • -
  • February 11 2015

On September 24, the Food and Drug Administration (FDA) released a final guidance document clarifying the revised custom device exemption implemented

FDA releases final MDDS and updated Mobile Medical Apps Guidance documents

  • Hogan Lovells
  • -
  • USA
  • -
  • February 9 2015

On February 9, 2015, the U.S. Food and Drug Administration (FDA) finalized its guidance, "Medical Device Data Systems, Medical Image Storage Devices

FDA issues simpler draft form for Individual Patient Expanded Access Applications

  • Hogan Lovells
  • -
  • USA
  • -
  • February 5 2015

On February 4, 2015, the Food and Drug Administration (FDA) issued a new Draft Guidance titled Individual Patient Expanded Access Applications: Form

340B program: orphan drug exceptiona timeline of PhRMA's legal challenge to HRSA's final rule

  • Hogan Lovells
  • -
  • USA
  • -
  • February 5 2015

On Wednesday, August 27, 2014, the U.S. District Court for the District of Columbia entered final judgment in the legal challenge to the final rule

Interoperability and privacy are buzzwords at 2015 ONC annual meeting

  • Hogan Lovells
  • -
  • USA
  • -
  • February 4 2015

Federal health IT leaders emphasized interoperability and computable privacy during the two-day Annual Meeting of the U.S. Office of the National

Two draft guidances indicate FDA may expand the scope of HCTP products subject to premarket review

  • Hogan Lovells
  • -
  • USA
  • -
  • January 27 2015

On December 17 and December 24, 2014, the Food and Drug Administration (FDA or the Agency) published two related, human tissue-focused draft guidance

FDA issues new guidance on cGMP for combination products

  • Hogan Lovells
  • -
  • USA
  • -
  • January 23 2015

On January 23, 2015, FDA issued its long-awaited guidance document on current good manufacturing practice (cGMP) requirements for combination