- Safety Evaluation of Impurities in Generic Drugs

The FDA’s Office of Generic Drugs (OGD)-Division of Pharmacology/Toxicology (Pharm/Tox) Review (DPTR) conducts safety assessments to ensure that generic drugs have similar safety profiles as their respective reference listed drugs (RLDs). The impurity profile of a generic drug may differ from its RLD due to allowable differences in manufacturing processes of the active pharmaceutical ingredient and finished drug product. Justifications are submitted to support the safety of generic drugs so that they can be substituted for the RLD. This webinar will focus on the safety evaluation of drug substance-related and drug product-related impurities in generic drugs. Key principles in the safety evaluation of genotoxic and non-genotoxic impurities will be discussed. OGD’s Division of Pharm/Tox Review approaches and relevant guidances for the safety evaluation of impurities will be discussed. In addition, case studies will be presented to highlight common data gaps/pitfalls as well as successful practices seen in impurity safety justifications submitted by applicants and DMF holders.

- Everything but the API: Evolving Methods for Impurity Hazard Identification and Risk Assessment

There are almost no pharmaceutical products that are given to patients as a pure substance; the promiscuous nature of chemical reactions means that there are often substances within a drug that are not the chemical entity defined as the drug product or substance. Furthermore, residual solvents, elemental impurities, shared manufacturing facilities and degradation products must also be considered in the toxicological profile of a drug. This talk will examine current guidelines, thresholds, regulatory experience, and methodologies for examining potential impurities found in pharmaceuticals.