News & Analysis as of September 22, 2024

Prescription Drugs › Animal Health

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FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

Alston & Bird on 3/22/2024

Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved or conditionally approved...more

Alternative Means for FDA Approval of Pet Care Drugs – Part 2: Extended Conditional Approval

Holland & Hart LLP on 6/30/2023

In this article, we look at how Expanded Conditional FDA Approval has the potential to incentivize drug development and provide veterinarians with legally-marketed new animal drugs to treat serious or life-threatening...more

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Prescription Drugs › Animal Health

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

Alternative Means for FDA Approval of Pet Care Drugs – Part 2: Extended Conditional Approval

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