RT Book, Section A1 Waning, Brenda A1 Montagne, Michael SR Print(0) ID 2643161 T1 Chapter 8. Post-Marketing Surveillance T2 Pharmacoepidemiology: Principles and Practice YR 2001 FD 2001 PB The McGraw-Hill Companies PP New York, NY SN 9780071355070 LK accesspharmacy.mhmedical.com/content.aspx?aid=2643161 RD 2024/10/13 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.