The system, to be established by the US Securities and Exchange Commission (SEC) and the North American Securities Administrators Association (NASAA)(1), will be based on technology used in the new Web-based Central Registration Depository (CRD) coming on line later this month.
Minivelle is currently the smallest estrogen patch available at 2.48cm 2 per patch (about 34% smaller than Vivelle-Dot). Minivelle contains bioidentical estradiol, a plant-based estrogen that is chemically identical to the estrogen produced naturally by a woman's body.
â¢ This MAPP describes the Office of Generic Drugs (OGD) policy and procedures for review of investigational new drug applications (INDs) submitted for bioavailability or bioequivalence studies under 21 CFR 320.31. As stated in 21 CFR 320.31(a), any sponsor planning to conduct an in vivo bioavailability or bioequivalence study in humans should submit a Bio-IND if: (1) The study involves a radioactive labeled drug product, or (2) The study involves a cytotoxic drug.