Form FDA 3489

Submission and Review Process in the EU 117 INSTRUCTIONS FOR FILLING OUT FORM FDA 3S6h... 

Annual Report = periodic reports for licensed biological products (for NDAs Form FDA-2252 should be used as required in 21 CFR 314.81 (b)(2)) ... 

Items I through 20 on the reverse side of the form constitute a check list that should be used to indicate the types of information contained within a particular submission. Please check all that apply. The numbering of the items on the checklist is not intended to specify a particular order for the inclusion of those sections into the submission. The applicant may include sections in any order, but the location of those sections within the submission should be clearly indicated in the Index. It is therefore recommended that, particularly for large submissions, the Index immediately follows the Form FDA 356h and, if applicable, the User Fee Cover Sheet (Form FDA 3397). 

Figure 12.2 Form FDA 2656 used for registration of a drug establishment.

Form FDA 3500 Voluntary reporting of adverse events (reactions, failures, malfunctions) with drugs or devices by medical personnel... 

Form FDA 3500A Mandatory reporting of adverse drug events by manufacturers Mandatory reporting of adverse device events by manufacturers, importers and device user facilities... 

Form FDA 1932 Mandatory reporting of Veterinary Adverse Drug Reactions, Lack of Effectiveness, or Product Defects by manufacturers... 

R. C. Schultz, Stability of Dosage Forms, FDA-Industry Interface Meeting, Washington, DC, Oct. 7, 1983 Stability Guidelines, Congressional Record, May 7, 1984. 

ICH has also given guidance on design, dose selection, statistical analysis and interpretation for such studies (1995, 1996, 1997). FDA has also offered guidance, the most recent form (FDA, 2001) in a 44-page document available on line. 

Reporting Forms. FDA form 3500/3500A (see Figure 20.1) is the standard form for notifying expedited reports and can also be used by companies to submit IND safety reports. Foreign cases may be reported on the CIOMS I form. 

If the inspector believes the cGMP has been violated. Form FDA-483 is used to record the observations. Samples may be taken by the FDA inspector for analysis. In this case, Form FDA-484 is issued to the manufacturer for the receipt of samples. A normal practice for the manufacturer is to take more samples for internal analysis and compare them with the FDA data when required. 

After inspection, the inspector prepares a detailed Establishment Inspection Report (EIR). This is the FDA s primary record for the inspection. Time is given to the manufacturer to respond to the deficiencies found and recorded on Form FDA-483. Failure to comply with satisfactory resolution of the deficiencies found will result in the FDA sending out a Warning Letter notifying the manufacturer to comply. If the manufacturer is unable to resolve the deficiency after the deadline set by the FDA, the FDA may proceed to prosecute the manufacturer with an injunction. The injunction is a court order called Consent Decree, and the manufacturer may be required to cease operations until the problem is rectified (see Exhibit 10.4). 

Regulatory authorities inspect GMP facilities to ensure compliance to GMP. The FDA carries out surveillance and compliance inspections. A system-based approach is adopted quality, facilities and equipment, materials, production, packaging and labeling, and laboratory control. Deficiencies are reported on Form FDA-483, which may lead to a warning letter and consent decree if unresolved. 

Where FDA determines any deviation from GMP, the inspector leaves a form, FDA-483, specifying the manufacturing deficiencies. It is essential in these circumstances that the company immediately make all corrections and respond to FDA in writing about them. It can be expected that FDA will reinspect the establishment and look both for what has been done to correct the prior deficiencies and for any new deficiencies that can be found. The pharmaceutical industry believes that FDAoften lists insignificant matters, that establishments which have passed without observed deficiencies in the past suddenly will be the subject of major deficiencies because of a change of inspectors or of interpretation, and that the requirements vary widely from individual inspector to individual inspector and from FDA district to FDA district. The industry has found, however, that its complaints fall on deaf ears, and thus that it must comply with whatever is required by the individual inspector or face the threat of serious regulatory action. 

If the inspector determines that there are deviations from cGMP, he will complete a form FDA-483 (Inspectional Observations) detailing the violations. The findings are presented to the manufacturer, which is given an opportunity to respond. The FDA-483 advises ... 

In addition to providing a form FDA-483, FDA investigators prepare an establishment inspection report (EIR), which is sent to FDA headquarters, which then evaluates the report and determines the corrective action, if any. The FDA then classifies the inspection as no action indicated, voluntary action indicated, or official action indicated. The EIR contains much greater detail than contained in the 483 and is not provided to the manufacturer until after the inspection is deemed closed. 

For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h "Application to Market a New Drug, Biologic or an Antibiotic Drug for Human Use" May 1999... 

To submit electronically a request for a meeting or teleconference, the sponsor should use the Request for a Meeting or Teleconference form provided by the CVM (Form FDA 34895 OMB No. 0910-0452). The sponsor should enter the data directly into an Adobe Acrobat form, attach the Agenda for the meeting, and submit the form to CVM as an Adobe portable document format (PDF) file (compatible with Adobe Acrobat 6.0).6 The electronic submission of a request for meeting or teleconference is part of the Center s ongoing initiative to provide a method for paperless submissions. 

A copy of Form FDA 3489 Request for a Meeting or Teleconference (for use with electronic submissions) is available on the CVM Electronic Submission Page at http //www.fda.gov/cvm/esubstoc.html. 

Checklist for Electronic Submission of a Request for a Meeting or Teleconference Using Form FDA 3489... 

An applicant submitting an electronic request for a meeting or teleconference should create an agenda as a single PDF file. This file will be attached to Form FDA 3489. This checklist describes the process applicants should follow to fill out the form, attach the agenda, and submit the information. 

Where to Send the Application. The initial IND submission and each subsequent submission to the IND should be accompanied by a Form FDA 1571 and must be submitted in triplicate (the original and two photocopies are acceptable). Mailing addresses for initial IND submissions are... 

Filling Out the Form FDA 1571. The numbers below correspond to the numbered boxes on the Form FDA 1571. 

If an emergency IND number was previously assigned by the FDA, or the Form FDA 1571 is being included with an amendment to the original IND, then that IND number should be entered here otherwise, the space should be left blank. 

Item 6 requires that the protocol be submitted, along with information on the investigators, facilities, and IRB, copies of the completed Form FDA 1572 with attachments would suffice for 6 b-d. 

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