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CMS Revises Medicare Part B Biosimilar Coding and Payment Policies
  • Covington & Burling LLP
  • USA
  • November 8 2017

On November 1 and 2, 2017, the Centers for Medicare & Medicaid Services ("CMS") released two final rules addressing changes to Medicare Part B

FDA Announces Public Meetings and Requests Comments on Agricultural Biotechnology Education and Outreach Initiative
  • K&L Gates
  • USA
  • October 16 2017

On October 13, 2017, the U.S. Food and Drug Administration (the “FDA”) announced in the Federal Register a notice of two upcoming public meetings and

FDA Invites Feedback from Stakeholders on Agency Regulations
  • Troutman Sanders LLP
  • USA
  • September 18 2017

With all the recent litigation, legislative efforts, and controversy centered around the U.S. Food and Drug Administration’s Deeming Rule, perhaps

US - Identifying trading partners under the Drug Supply Chain Security Act
  • Baker McKenzie
  • USA
  • August 24 2017

On August 24, 2017, the U.S. Food and Drug Administration (FDA) published in the Federal Register a notice Docket No. FDA-2017-D-1956 announcing the

FDA Publishes Q&A on Precertification Pilot Program for Software Developers
  • Barnes & Thornburg LLP
  • USA
  • August 18 2017

On September 1, the Food and Drug Administration (FDA) will launch a precertification pilot program for software developers, but has limited the

FDA Will Exercise Enforcement Discretion for the Use and Labeling of “Ultrafiltered Milk” in Certain Cheeses and Cheese Products
  • Keller and Heckman LLP
  • USA
  • August 11 2017

Mechanical filtration technologies available for milk processing include ultrafiltration. Ultrafiltered milk (UF Milk) is milk that is mechanically

New FDA Digital Health Program
  • Holland & Knight LLP
  • USA
  • August 1 2017

The Food and Drug Administration (FDA) continues to flesh out its ideas for regulation of digital health. Last week, the agency published a notice in

FDA Postpones Food Labeling Deadline
  • Reed Smith LLP
  • USA
  • July 28 2017

Last month, the U.S. Food and Drug Administration ("FDA") pushed back the deadline for food companies to adopt changes to nutritional labels for

FDA Solicits Comments Regarding Two New Studies Related to Drug Promotion
  • Cooley LLP
  • USA
  • June 19 2017

The U.S. Food and Drug Administration (FDA) published two Federal Register notices today announcing its intent to study different aspects of drug

FDA Delays Implementing Nutrition and Supplement Facts Label Rules
  • Bryan Cave LLP
  • USA
  • June 16 2017

The FDA has announced that it is delaying implementation of the Nutrition Facts and Supplement Facts Label and Serving Size final rules. As we