Editing Food and Drug Administration (section)

=====Post-market safety surveillance=====
After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis.<ref>21 CFR 314.80: Postmarketing Reporting of Adverse Drug Experiences</ref> The FDA also receives directly adverse drug event reports through its [[MedWatch]] program.<ref>{{cite web | url = https://www.fda.gov/Safety/MedWatch/default.htm | title = MedWatch: The FDA Safety Information and Adverse Event Reporting Program | archive-url = https://web.archive.org/web/20190422112808/https://www.fda.gov/Safety/MedWatch/default.htm | archive-date=April 22, 2019 | access-date = October 9, 2007 | publisher = U.S. Food and Drug Administration }}</ref> These reports are called "spontaneous reports" because reporting by consumers and health professionals is voluntary.

While this remains the primary tool of [[Postmarketing surveillance|post-market safety surveillance]], FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional [[clinical trials]], called Phase IV trials. In some cases, the FDA requires risk management plans called [[Risk Evaluation and Mitigation Strategies]] (REMS) for some drugs that require actions to be taken to ensure that the drug is used safely.<ref name=Nelson>{{cite journal | vauthors = Nelson LS, Loh M, Perrone J | title = Assuring safety of inherently unsafe medications: the FDA risk evaluation and mitigation strategies | journal = Journal of Medical Toxicology | volume = 10 | issue = 2 | pages = 165–172 | date = June 2014 | pmid = 24414251 | pmc = 4057549 | doi = 10.1007/s13181-013-0374-z }}</ref><ref>{{cite journal | vauthors = Brown WV, Bramlet DA, Ross JL, Underberg JA | title = JCL roundtable: Risk evaluation and mitigation strategy | journal = Journal of Clinical Lipidology | volume = 10 | issue = 6 | pages = 1288–1296 | date = October 14, 2016 | pmid = 27919344 | doi = 10.1016/j.jacl.2016.10.007 }}</ref> For example, [[thalidomide]] can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many [[opioid]] drugs have REMS programs to avoid addiction and diversion of drugs.<ref name=Nelson/> The drug [[isotretinoin]] has a REMS program called [[iPLEDGE]].<ref>{{cite journal | vauthors = Kovitwanichkanont T, Driscoll T | title = A comparative review of the isotretinoin pregnancy risk management programs across four continents | journal = International Journal of Dermatology | volume = 57 | issue = 9 | pages = 1035–1046 | date = September 2018 | pmid = 29508918 | doi = 10.1111/ijd.13950 | s2cid = 3726217 }}</ref>