TY - CHAP M1 - Book, Section TI - Chapter 8. Post-Marketing Surveillance A1 - Waning, Brenda A1 - Montagne, Michael PY - 2001 T2 - Pharmacoepidemiology: Principles and Practice AB - Post-marketing surveillance (PMS) is the identification and collection of information regarding medications after their approval by the U.S. Food and Drug Administration (FDA). Systematic PMS of drugs began in the early 1970s and has increased substantially since then. The monitoring of drugs after their approval has become necessary for many reasons. In the 1950s and 1960s, there were fewer drugs available and, thus, fewer drugs to monitor. Today, drugs are being developed and consumed at increasingly high rates. Other factors contributing to the need for PMS include changes in the FDA’s approval process. As discussed in Chapter 4, this lengthy process has been criticized. The FDA has responded by developing channels and opportunities for patients in need to obtain critical drugs. As a result, the dangers associated with use of some drugs may not be determined in the premarketing phase. SN - PB - The McGraw-Hill Companies CY - New York, NY Y2 - 2024/11/02 UR - accesspharmacy.mhmedical.com/content.aspx?aid=2643161 ER -