NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Daniel Davis, MD, MPH

Practice Area Focus

  • Drugs
  • Devices
  • OTC
  • Combination Products
  • Regulatory Strategy & Submissions
  • Development Strategy
  • Drug Safety
  • Obstetrics and Gynecology
  • Infectious Diseases

Biography

Dr. Daniel Davis joined NDA Partners as an Expert Consultant in 2017. He was formerly a Medical Officer for 19 years with the FDA Division of Bone, Reproductive and Urologic Products (DBRUP) within CDER where he reviewed 100’s of INDs and numerous NDAs for all forms of contraception, heavy menstrual bleeding, female sexual dysfunction (FSD), fibroids, overactive bladder, female and male hormone replacement, medical abortion, and products undergoing OTC switch. He drafted new guidelines at FDA for clinical trials for bacterial vaginosis, spermicides, microbicides for HIV prevention, FSD, emergency and hormonal contraception, and reviewed ISO guidances. His expert consulting includes advising on clinical trial design, evaluating efficacy and safety data, and reviewing, editing, and writing FDA regulatory submissions.

Prior to joining FDA, Dr. Davis was in private practice of Obstetrics, Gynecology and Infertility for twenty years and is an expert in all forms of non-hormonal and hormonal contraception, FSD, gynecological disorders, menopausal drugs, and HIV prevention using vaginal medications. He is board certified in Obstetrics and Gynecology, and a former Fellow of The American Congress of Obstetricians and Gynecologists and the American Public Health Association.