22-B DCMR 10623
10623. NEW INDICATIONS FOR USE
Cite as D.C. Mun. Regs. tit. 22-B, § 10623
10623 NEW INDICATIONS FOR USE
10623.1 An applicant seeking a new indication for use of a HUD approved under this section shall obtain a new designation of HUD status in accordance with § 10619 and shall submit an original HDE in accordance with § 10620.
10623.2 An application for a new indication for use made under § 10620 may incorporate by reference any information or data previously submitted to the Department under an HDE.
SOURCE: Final Rulemaking published at 60 DCR 10252 (July 12, 2013).
District of Columbia Municipal Regulations
Public Health and Medicine
22-B DCMR § 10623