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FDA issues interim cGMP guidance for outsourcing facilities

  • Hogan Lovells
  • -
  • USA
  • -
  • July 24 2014

On July 1, the Food and Drug Administration (FDA) issued interim guidance describing the Agency's expectations for compliance with current Good

FDA issues Draft Guidance on informed consent regulations

  • Hogan Lovells
  • -
  • USA
  • -
  • July 22 2014

On July 15, 2014, the Food and Drug Administration (FDA or the Agency) announced a new Draft Guidance, Informed Consent Information Sheet: Guidance

FDA issues revised draft guidance on Reporting Drug Sample Information Under the ACA

  • Hogan Lovells
  • -
  • USA
  • -
  • July 22 2014

On July 11, FDA issued new draft guidance concerning drug sample reporting mandated under the Affordable Care Act (ACA). The guidance, Reporting Drug

FTC director addresses enforcement efforts in the healthcare sector

  • Hogan Lovells
  • -
  • USA
  • -
  • July 17 2014

In an informative speech at the recent Accountable Care Organizations Summit, Federal Trade Commission (FTC) Director of the Bureau of Competition

OIG issues Special Fraud Alert targeting lab payments for specimen collection and registry participation

  • Hogan Lovells
  • -
  • USA
  • -
  • July 8 2014

Expanding on its longstanding concerns about payments by clinical laboratories to referring physicians, the Office of Inspector General (OIG

FDA proposes enforcement discretion for medical device data systems, medical image storage solutions, and medical image communications devices

  • Hogan Lovells
  • -
  • USA
  • -
  • June 24 2014

In a 20 June 2014 draft guidance, the Food and Drug Administration (FDA or Agency) proposed that, once the guidance is finalized, the Agency would

340B program: HRSA posts orphan drug exclusion policy, PhRMA responds

  • Hogan Lovells
  • -
  • USA
  • -
  • June 19 2014

There have been a number of developments since the U.S. District Court for the District of Columbia "vacated," or invalidated, HRSA's final rule on

FDA issues long-awaited draft guidances on internet and social media advertising

  • Hogan Lovells
  • -
  • USA
  • -
  • June 17 2014

This morning, the Food and Drug Administration (FDA) finally issued long awaited guidelines regarding internet and social media advertising for

FDA issues new draft guidance on identification of suspect products and notification

  • Hogan Lovells
  • -
  • USA
  • -
  • June 13 2014

On 11 June 2014, FDA announced the availability of a draft guidance titled "Drug Supply Chain Security Act Implementation: Identification of Suspect

FDA grants MIWG petitions requesting a full review of agency regulations and policies on the communication of medical and scientific information about investigational products and unapproved new uses

  • Hogan Lovells
  • -
  • USA
  • -
  • June 11 2014

On June 6, 2014, FDA granted (see full response here) a series of Citizen Petitions submitted by the Medical Information Working Group ("MIWG") in