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FDA Makes Two Announcements on Electronic Tracking of Prescription Drugs to Comply with the Drug Supply Chain Security Act
  • Hogan Lovells
  • USA
  • July 20 2017

On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to


House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech
  • Hogan Lovells
  • USA
  • July 8 2017

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017


Follow the Money: FDA Issues New Procedures for Evaluating Financial Ties Between Application Sponsors and Clinical Investigators
  • Hogan Lovells
  • USA
  • July 5 2017

In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA


SCOTUS Narrows Opportunity For ITC Section 337 Jurisdiction Over Imported Biosimilars Based On 180-Day Notice Provision
  • Hogan Lovells
  • USA
  • June 28 2017

Under 42 U.S.C. 262 (l)(2)(A) of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), an Applicant seeking FDA approval of a


Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical investigations
  • Hogan Lovells
  • USA
  • June 27 2017

Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 Questions and Answers." The draft guidance is intended


Draft Senate Health Bill Finally Revealed Vote Could Take Place as Early as Next Week
  • Hogan Lovells
  • USA
  • June 23 2017

On June 22, 2017, Republican Senators released a "discussion draft" of the Better Care Reconciliation Act (BCRA). The draft is the first public


Continuous Manufacturing of Pharmaceuticals: FDA Wants to Hear from Industry
  • Hogan Lovells
  • USA
  • June 23 2017

Continuous manufacturing has often been highlighted by FDA as an exciting technology in the area of pharmaceutical manufacturing, but one that the


Slow but Steady: CMS Proposes to Simplify and Slow Down the Quality Payment Program Rollout
  • Hogan Lovells
  • USA
  • June 23 2017

On Tuesday, June 20, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule1 to continue the rollout of the Quality Payment


The Challenges Surrounding Patenting 3-D Bioprinted Organ and Tissue Technology
  • Hogan Lovells
  • USA
  • June 20 2017

In this hoganlovells.com interview, New York-based partner Arlene Chow talks about the emergence of 3-D bioprinting and the ability of innovators in


FDA Requires Reprocessing Validation Data for Certain Reusable Devices
  • Hogan Lovells
  • USA
  • June 20 2017

On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of