The US Food and Drug Administration (FDA) regulates the approval and safe public use of
pharmaceutical products in the United States. The FDA uses postmarket surveillance …

Comprehensive methods for evaluating safety are needed to objectively assess the full risk
profile of a medication. The confidence of the prescribing provider in the safety and …

Postmarketing drug safety surveillance has undergone many changes, especially over the
past decade when international harmonization on safety reporting and risk management …

Much has changed in a relatively short period of time. There is a raging debate over the
level of evidence expected to first introduce a treatment to patients based on smaller, more …

Contemporary medicine is a large and complex system involving many participants, all of
whom play a critical role in managing the risks intrinsic to medical product use. Despite the …

Although international medicines regulators adopt a common system to assess the safety
and efficacy of new drugs, pre-market evaluation is recognized as incomplete given the …

Postmarketing drug safety surveillance is a challenging and vital component of
contemporary medical practice. Obtaining new information about the benefits and risks of a …

Post-Authorization Safety Studies of Medicinal Products: The PASS Book bridges the gap in
the literature by providing a complete look at post-authorization safety studies and important …

In addition to standard postmarketing drug safety monitoring, Section 915 of the Food and
Drug Administration Amendments Act of 2007 (FDAAA) requires the US Food and Drug …

Highlights•Pharmacoepidemiology studies need to consider a myriad of approved
drugs.•Undetected immunogenicity of biotherapeutics can impact patient safety.•Anti-drug …