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Results: 1-10 of 409

Medicaid drug rebate program: HHS OIG issues report on dispute resolution between manufacturers and states

  • Hogan Lovells
  • -
  • USA
  • -
  • August 28 2014

On Wednesday, August 20, 2014, the Office of Inspector General (OIG) of the U.S. Department of Health & Human Services (HHS) released areport

Federal Circuit revives certain sham petitioning antitrust counterclaims in Tyco-mutual ANDA litigation

  • Hogan Lovells
  • -
  • USA
  • -
  • August 26 2014

In a split decision, the U.S. Court of Appeals for the Federal Circuit affirmed summary judgment on two antitrust counterclaims brought by Mutual

FDA issues two proposed guidance documents for Laboratory Developed Tests

  • Hogan Lovells
  • -
  • USA
  • -
  • August 25 2014

On July 31, 2014, FDA provided Congress advance copies of two proposed guidance documents regarding Laboratory Developed Tests (LDTs), which the

FDA releases revised de novo pathway guidance

  • Hogan Lovells
  • -
  • USA
  • -
  • August 19 2014

On August 14, 2014, the U.S. Food and Drug Administration (FDA or the Agency) released an updated draft guidance document regarding de novo premarket

California appeals court rules that mere possession of medical information by unauthorized person is insufficient to support breach claims under the CMIA

  • Hogan Lovells
  • -
  • USA
  • -
  • August 6 2014

In a ruling that was welcome news to health care providers, insurers, and others that maintain medical information of California residents, the

Finalized and draft 510(k) guidance documents formalize and clarify FDA’s evaluation of substantial equivalence

  • Hogan Lovells
  • -
  • USA
  • -
  • August 5 2014

On July 28, 2014, the U.S. Food and Drug Administration (FDA) finalized its guidance, The 510(k) Program: Evaluating Substantial Equivalence in

FDA issues final guidance regarding in vitro companion diagnostic devices

  • Hogan Lovells
  • -
  • USA
  • -
  • August 5 2014

The Food and Drug Administration (FDA or the agency) announced on July 31, 2014, the publication of a final guidance on in vitro

FDA notifies Congress of the proposed regulatory oversight of laboratory developed tests

  • Hogan Lovells
  • -
  • USA
  • -
  • August 5 2014

On July 31, 2014, the U.S. Food and Drug Administration (FDA or the Agency) announced plans to formally regulate laboratory developed tests (LDTs

IRS releases final branded prescription drug fee regulations

  • Hogan Lovells
  • -
  • USA
  • -
  • July 28 2014

On 24 July 2014, the Internal Revenue Service (IRS) released final regulations to implement Section 9008 of the Affordable Care Act (as amended by

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