  |
|
 |
|
FDA Home Page | Federal-State | Import Program | Compliance | Inspection | Science | ORA Search  | ||
AIP Procedures1-2 Attachments and ExhibitsATTACHMENTS:
ATTACHMENT A - AIP COMMITTEE MEMBERS/ AIP CONTACT PERSONSSee an updated list of AIP Committee Members/AIP Contact Persons at http://www.fda.gov/ora/compliance_ref/AIP_Contacts.htm. ATTACHMENT B - "MODEL" LETTERS TO THE APPLICANTAttached are examples of two letters that are suggested to be used as model formats: (1) to invoke the AIP, and (2) to revoke the AIP.
Date The Center for [applicable center] has determined that [firm name] submitted [select one or more] a fraudulent application with the Agency, or made untrue statements of material fact, or gave or promised bribes or gratuities to an Agency official. These findings are more fully described in [a letter dated...indicating our intention to withdraw approval of the NDA/ANDA/PLA/BLA for [product], and/or an FDA 483 Inspectional Observations form issued to [firm] on [date]. These findings raise significant questions regarding the reliability of data in [either all or identify the subset] applications (pending and approved) that [firm] has filed with the Agency. In accordance with FDA policy, the Agency will assess the validity of the data and information in all of [firm(s')] affected applications. This assessment will take priority over substantive scientific data review until data integrity questions are resolved. This means that the Agency will defer substantive scientific review (including review of data and labeling) of any pending application, or of any new application or supplemental application filed after the date of this letter. The Agency may continue or resume substantive review of an application prior to completion of the validity assessment in special circumstances where such an action is clearly in the interest of public health. The Agency's policies regarding validity assessments and corrective actions that companies may take are described more fully in the Agency's policy entitled "Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities; Final Policy," which was published in the Federal Register of Tuesday, September 10, 1991. Guidance for firms (regarding audits) and the Agency in conducting validity assessments is also contained in a document entitled "Points to Consider for Internal Reviews and Corrective Action Operating Plans", the availability of which was announced in the same issue of the Federal Register. Enclosed are copies of both documents. The local FDA District Office is available to meet with you to discuss resolution of the data integrity and reliability questions raised in the above-mentioned applications. To arrange a meeting with the District Office, please write to or call: District Director's name, title To discuss the Agency's finding that a validity assessment is warranted, please contact: U.S. Food and Drug Administration Alternatively, you may withdraw the application based on [applicable Center regulation]. A listing that identifies all the firm's currently approved and pending applications filed with the Agency, including those applications for which the Agency invoked the AIP is enclosed. Please inform the Agency of the action you intend to take with regard to each of the applications within ten days of the date of issuance of this letter.
cc: [AIP CONTACT PERSONS NEED TO PROVIDE MAIL CODES FOR ALL IN THEIR CENTER (AREA) WHO SHOULD BE CC'D ON LETTERS FROM OTHER CENTERS THAT INVOKE THE AIP] Date
The Center for [applicable center] advised [firm] in a letter dated [insert date] that the Agency deferred substantive review of [all or identify the subset] approved and/or pending applications submitted by [firm] until questions regarding the reliability of the data were resolved. Since that date, [firm] has advised the FDA that it conducted an internal review to identify and correct the circumstances which gave rise to the submission of fraudulent applications or untrue statements of material fact, which caused the Agency to question the validity and reliability of data in the applications. Furthermore, [firm] has submitted to [Center] and substantially executed a Corrective Action Operating Plan (Plan) applicable to all of [firm] products that contain adequate safeguards and procedures designed to preclude future wrongful acts and noncompliance with regulatory requirements. The FDA's [_____] District Office [or identify the applicable Center investigating unit] has conducted a validity assessment inspection of your firm and has determined that [firm] appears to have implemented the commitments made in the Plan. Therefore, I have directed my staff to resume substantive scientific review of the affected applications. For an application that was withdrawn by the firm and that was not included in the validity assessment, the firm has committed to not refile or reactivate that application until the Agency is satisfied with the reliability of the data/information. If the validity assessment found that the data in the withdrawn application were unreliable, the applicant who wishes to replace the data should submit a new application according to the AIP (56 FR 46191, at 46200). Resumption of substantive scientific review by the FDA of [firm's] applications is not to be construed as approval of any conditions that may be found in the future. Please be advised that the FDA expects [firm] to adhere to the commitments made in its Corrective Action Operating Plan, and the Agency will monitor the firm's operations to verify continued compliance. Should it be determined at any time in the future that [firm] has failed to comply with its commitments, the FDA will not hesitate to take appropriate action. If you have any questions, you may contact [Center Discretion], at [telephone].
cc:
[AIP CONTACT PERSONS NEED TO PROVIDE MAIL CODES FOR ALL IN THEIR CENTER (AREA) WHO SHOULD BE CC'D ON LETTERS FROM OTHER CENTERS THAT INVOKE THE AIP] March 5, 1998 Edit March 4, 2004 for format SS:KS(HFC-230) |
||||
|
||||