The U.S. Patent and Trademark Office (USPTO) has released new training materials on “Declaration practice under 37 CFR 1.132 (Rule 132).” The materials were developed under a collaboration initiative with the U.S. Food and...more
The labeling of biosimilar products as “interchangeable” may be important in order to gain acceptance and use in the medical community. This article provides important information regarding revised FDA labeling guidance for...more