Last November, we posted that the Food and Drug Administration (FDA) had approved a genetically engineered (GE) salmon: AquaBounty Techonologies’ AquAdvantage Salmon. This approval marked the first time that the FDA authorized selling a genetically engineered animal for human consumption.

Immediate backlash followed the FDA’s November 19, 2015 announcement from environmental and consumer advocacy groups. On March 31, 2016, environmental and food safety groups, as well as fisherman trade associations, sued the FDA and related agencies in federal court in California. The suit seeks to reverse the FDA’s approval of the fish for human consumption.
Continue Reading Lawsuit Challenges FDA Approval of Genetically Engineered Salmon

On November 19, 2015, the Food and Drug Administration (FDA) approved as fit for human consumption a genetically engineered (GE) salmon. AquaBounty Technologies AquAdvantage Salmon has been modified to grow faster than non-engineered farmed salmon. This marks the first time the FDA has authorized the sale of a genetically engineered animal as food.

Because the FDA determined that there are “no biologically relevant differences in the nutritional profile of AquAdvantage Salmon compared to that of other farm-raised Atlantic salmon,” AquAdvantage will not need to label the fish as genetically modified. The FDA further found that approving the GE salmon would have no negative environmental impact.
Continue Reading FDA Approves First Genetically Engineered Animal for Human Consumption

On Monday, August 3rd, the Food and Drug Administration (FDA) approved the first 3D printed pill, signaling a new opportunity for drug makers and 3D printing technology.

Spritam, a medication for epilepsy, is manufactured by Ohio-based pharmaceutical company, Aprecia Pharmaceuticals.  This particular drug has already been on the market, but the new, 3D printed version, is designed to dissolve more rapidly than any other seizure medication.  This new design also allows for a high drug load to be delivered in a single dose, limiting the number of pills necessary.  The 3D printed design may be particularly helpful for children or other patients who have difficulty swallowing large pills.  By layering medication, 3D printing allows the creation of a more porous pill that can dissolve more quickly into liquid.  The pill should be available commercially early in 2016. 
Continue Reading FDA Approves First 3D Printed Pill