Orphan product definition

Orphan product means a product that lacks a brand, for which the producer is no

Orphan product means a covered electronic product that lacks

Orphan product means a covered electronic product that lacks a manufacturer's brand or for which the manufacturer is no longer in business and has no successor in interest.

Examples of Orphan product in a sentence

• Orphan product designation must be requested before submitting an NDA.

• Orphan product designation does not convey any advantage in or shorten the duration of the regulatory review and approval process.

• Orphan product designation does not convey any advantage in or shorten the duration of regulatory review and approval process.

• Orphan product exclusivity also could block the approval of one of our products for seven years if a competitor obtains approval of the same biological product as defined by the FDA or if our product candidate is determined to be contained within the competitor’s product for the same indication or disease.

• Orphan product grants are a proven method of fostering and encouraging the development of new safe and effective medical products for rare diseases and conditions.

More Definitions of Orphan product

Orphan product means a covered electronic product that lacks a manufacturer's brand or for which the manufacturer is no longer in business and has no successor in interest, or is a brand for which ecology cannot identify an owner.

Orphan product means a mercury-containing light that lacks

Orphan product means a mercury-containing light that lacks a producer's brand, or for which the producer is no longer in business and has no successor in interest, or that bears a brand for which the department cannot identify an owner.

Orphan product means a pharmaceutical product that (a) satisfies the criteria for orphan drug designation established by the FDA or any other Regulatory Authority in the Territory; and (b) has received Regulatory Approval for an Indication other than an Excluded Orphan Indication.

Orphan product means any Licensed Product that [***].

Orphan product means, with respect to a country, a pharmaceutical product that is granted a period of regulatory exclusivity under the applicable Orphan Drug Law in such country.

Orphan product means a ((mercury-containing))