C. Methods validation package (e.g., 21 CFR 21 CFR 5. Nonclinical pharmacology and toxicology section (e.g., 21 CFR (d 21.
Content and format of an application. .. (ii) A copy of the information submitted under paragraph (d)(5)(vi)(a) of this section concerning a summary of.
21 CFR - Content and format of an application. Subchapter D - DRUGS FOR HUMAN USE Title 5 - Administrative Personnel.
Skip to Topics Menu. Effectiveness data from other subgroups of the population of patients treated, when appropriate, such as patients with renal failure or patients with different levels of severity of the disease, also shall be presented. A A statement that the route of administration, 5 dimes poker form, and strength of the proposed drug product are the same as those of the reference listed drug. If a final judgment finds the patent to 21 cfr 314.50 d 5 invalid and infringed, an amended certification is not required. If desired by the applicant, the FDA division director will verify in writing any request for additional data that was made orally. It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. Three copies of the application are required: An archival copy, a review copy, and a field copy.