00088 VALID Act Amending An Application

00088 VALID Act Amending An Application

From Valid Act (f) Amendments to an application.—

“(1) IN GENERAL.—An applicant may amend an original or supplemental application under subsection (c) or (d).

“(2) REQUIRED AMENDMENT OR SUPPLEMENT.—An applicant shall amend or supplement an application submitted under subsection (c) or (d) if the applicant becomes aware of information that—

“(A) could reasonably affect an evaluation of whether the applicable standard has been met; or

“(B) could reasonably affect the statement of contraindications, warnings, precautions, and adverse reactions in the proposed labeling.

“(3) REQUEST FOR AMENDMENT OR SUPPLEMENT.—The Secretary may request that an applicant amend or supplement an application under subsection (c) or (d) with any information necessary for review under this section.