DOES manipulating an egg prior to IVF turn it into an experimental “product”
that has to be regulated like a new drug or medical device? Yes, says the US
Food and Drug Administration.
This month, the agency wrote to several fertility clinics warning them that
any treatments that genetically alter egg cells or embryos would constitute a
“clinical investigation” and so fall under the agency’s authority. The
announcement will effectively prevent clinics using a controversial technique
known as “ooplasmic transfer”. This involves adding cytoplasm from a healthy
young woman’s egg to the egg of an older woman, which is supposed to improve the…
