FDA Aims to Create Online Database of Bioequivalence Study Guidelines
Information on designing bioequivalence studies for various types of products would be available online under a draft guidance issued by the FDA’s Office of Generic Drugs.
To receive approval for an abbreviated new drug application (ANDA), a generic drugmaker must prove that the generic product is absorbed at the same rate as the comparator drug, a concept known as bioequivalence, according to the FDA.
Currently, drugmakers can submit requests for assistance in bioequivalence study design to the Office of Generic Drugs, and the agency responds to individual companies in written form, according to the guidance, which was published in the May 31 Federal Register.
The FDA recently published a report detailing many of the scientific issues that impede the development of generic drugs, including the need for improved bioequivalence testing methods.
The agency has also published in the Federal Register a guidance listing roughly 200 drugs for which bioequivalence study recommendations are now available. The individual product guidelines are available at www.fda.gov/CDER/guidance/bioequivalence/default.htm.
Upcoming Events
-
23May
-
30May
-
13Jun
-
20Jun
-
21Oct