LIFE-CYCLE STRATEGIC PLANNING

KKB works closely with clients on strategic planning to ensure that products receive the full protections from competition that they are accorded under law. For example, we have developed and recommended approaches in the following areas:

		Legal standards for advertising applied by FDA, FTC, various State government agencies, and courts under the Lanham Act
		Innovator drug product exclusivity
		Orphan drug exclusivity
		Pediatric exclusivity
		Petitions to assure adequate scientific/legal showing of bioequivalence and therapeutic equivalence
		Generic drug product exclusivity
		Patent term restoration
		Effects of exclusivity on subsequent product development
		Products marketed without FDA approval
		Strategic approaches in preparation of Food Additive and GRAS submissions
		Strategic approaches to medical device labeling and innovation

We develop life-cycle strategies that take into consideration FDA and FTC requirements and current policies.