(a) An applicant may transfer ownership of its application. At the time of transfer the new and former owners are required to submit information to the Food and Drug Administration as follows: (1) The former owner shall submit a letter or other document that states that all rights to the application have been transferred to the new owner. (2) The new owner shall submit an application form signed by the new owner and a letter or other document containing the following: (i) The new owner's commitment
The procedures in this part apply when- (a) A person has a right to an opportunity for a hearing under the laws specified in § 10.50 ; or (b) The Commissioner concludes that it is in the public interest to hold a formal evidentiary public hearing on any matter before FDA. 21 C.F.R. §12.1
(a) The objective of a formal evidentiary hearing is the fair determination of relevant facts consistent with the right of all interested persons to participate and the public interest in promptly settling controversial matters affecting the public health and welfare. (b) Accordingly, the evidence at a hearing is to be developed to the maximum extent through written submissions, including written direct testimony, which may be in narrative or in question-and-answer form. (1) In a hearing, the issues
(a) The Commissioner shall promulgate regulations and orders after an opportunity for a formal evidentiary public hearing under part 12 whenever all of the following apply: (1) The subject matter of the regulation or order is subject by statute to an opportunity for a formal evidentiary public hearing. (2) The person requesting the hearing has a right to an opportunity for a hearing and submits adequate justification for the hearing as required by §§ 12.20 through 12.22 and other applicable provisions
If the Food and Drug Administration withdraws approval of an application or abbreviated application for a new drug, FDA will publish a notice in the FEDERAL REGISTER announcing the withdrawal of approval. If the application or abbreviated application was withdrawn for grounds described in § 314.150(a) or § 314.151 , the notice will announce the removal of the drug from the list of approved drugs published under section 505(j)(6) of the act and shall satisfy the requirement of § 314.162(b) . 21 C