The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Tag Archives: FDA Guidance

Trends in 2009: Genetically Engineered Animal Approvals

The past few weeks have seen at least three conspicuous developments towards a functional regulatory regime that will lead to increasing numbers of FDA approvals for Genetically Engineered (GE) animals:

  1. The FDA released their final Guidance on Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs (pdf), as well as a FAQ and comment responses.
  2. The FDA approved ATryn, a drug produced in the milk of GE goats.  Consistent with the Guidance, CBER approved the human biologic based on its safety and efficacy, and CVM approved the rDNA construct in the goats that produce ATryn.  In keeping with the comment responses, the FDA took steps to increase the transparency of the process by holding a public hearing prior to approval.
  3. Yesterday, a report surfaced (so to speak) about the FDA’s visit to Aqua Bounty Farms, in Prince Edward Island, Canada for an inspection in connection with Aqua Bounty’s application for approval of GE salmon, and the FDA spokesperson reached by CBC said approval could come “soon.”

All in all, it looks like the FDA is not wasting any time trying out its shiny new guidance.  Other Canadian products noted in the FAQ are “pigs with smaller environmental footprints, as well as GE animals intended to produce human pharmaceuticals.”

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News: FDA Off-Label Guidance

The FDA released updated guidance today on the use of journal articles to promote off-label uses.  Here is a link directly to the FDA guidance.

Here is the Reuters story, which notes some Congressional (Waxman) and consumer (Public Citizen’s Health Research Group) opposition, and PhRMA support.

One concern is that a permissive approach to off-label promotion will decrease incentives to file for approval of new uses.  We’re watching  to see if Wyeth v Levine will provide some new incentives in the opposite direction.

Comments on the new guidance?  Do you think it will survive in the new administration?  Discuss…

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