Draft details modifications to AOAC International’s PER rat bioassay method to show a formula meets quality factor of sufficient biological quality of protein, one factors FDA considers in evaluating submissions.
Draft guidance on designing, conducting, evaluating and reporting studies using rats and the Protein Efficiency Ratio (PER) bioassay merthod is the Food and Drug Administration’s latest move to strengthen the US infant formula supply chain.
The draft guidance announced on 9 February is intended to build “a more resilient infant formula industry” by helping...
Prominent trade groups call on the European Commission to improve risk assessment of innovative food products by making changes to processes at the European Food Safety Authority.
Along with two instructional videos, FDA provides fact sheet detailing common problems with NDINs while supplement industry awaits guidance on two hurdles for clearing the NDIN process, providing identity information and evidence of safety for ingredients.
Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
