Communication with the FDA

Once the initial IND application has been assigned a reference number, the sponsor can keep submitting information to the FDA file to enable the clinical development to move through the various trial phases. 

Information amendments are used to inform the FDA of new pharmacology or toxicology data, final non-dinical study reports, new chemistry-manufacturing-control information, or notice of the discontinuation of a clinical study. 

The sponsor is obliged to submit safety reports for SUSAR events to the same timelines as apply in Europe. They must also report within 15 days any findings from animal studies that would suggest an increased risk to human subjects, such as carcinogenidty or mutagenidty. 

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Requests for permission to conduct clinical trials with pharmaceuticals in the US are termed Investigational New Drug Applications (INDs). The applications are actually a request for an exemption to supply a drug without a marketing authorisation. A cover sheet (Form 1571) must accompany the application. This cover sheet should also be used with each subsequent communication with the FDA, with each form consecutively numbered, starting at 000 for the initial submission. A copy of the form is shovm in Figure 5.6. 

Responds as the expert resource for CDER to issues and meeting requests from the Office of the Commissioner and interfaces on common botanical issues and fosters communication with the FDA Center for Food Safety and Applied Nutrition and the National Center for Complementary and Alternative Medicine and the Office of Dietary Supplements at the National Institutes of Health (NIH). 

Communications with the FDA will take the form of meetings, telephone contacts, regulatory submissions, general correspondence, and faxes. Regardless of the form, each communication should be considered as an opportunity to build on the working relationship necessary for long-term... 

The firm could have prevented this situation and citation by ensuring that the appropriate person was responsible for communicating with the FDA s PAI manager to effectively schedule the inspection. The appropriate person is someone who has adequate interface with and information from the various departments, units, and personnel that need to be inspection-ready. Ideally, one individual is selected to communicate with various units within the company as well as the FDA. This person could be the PAI project manager or someone in the QA area. It is essential that this individual be apprised of the status of critical inspection activities, such as equipment qualification, process validation, and overall inspection-readiness. 

Communication with the FDA contact can take a variety of forms most will accept telephone calls and e-mails and will request formal, written communications when significant issues arise. But regardless of the format, keep your contact in the loop if schedules or plans change. 

Since the IND is often the first formal communication with the FDA, it often sets the tone for ongoing FDA relations. A reputation for care and diligence, built with a strong IND, can strengthen continuing interactions, while a poorly designed or incomplete IND can sour the same future relationships. 

For FCNs, specifications serve to ensure that the substance marketed by the manufacturer/supplier identified in the notification is the same as that subjected to the safety evaluation when the FCN became effective. Several specifications may be given in an FCN. Specifications are applicable only to the manufacturer/supplier identified in the FCN and are well known to them. Thus, they are generally not included in FCN letters. As noted above, the notifier is held to the specifications and use conditions identified in the FCN. Accordingly, changes in the manufacturing process that result in new impurity profiles may require communication with the FDA and, if warranted, new FCN submissions. 

The FDA has established a Request for Designation process that allows a Sponsor company to request the FDA to designate the lead Review Division for the product early in the development process. Thereafter, communication with the FDA on the product will go primarily to the lead Center however, it is important to assure that reviewers from both Centers are involved in the development process and all concerns and comments are incorporated into the product development strategy. 

It is important to maintain fluid communication with the FDA when applying for an IDE. The application process can take over a year or more and often more than one round of responses and requests for additional data on both sides of the submission. At the same time, the FDA provides the guidance needed to ensure complete disclosure of the device before its use in a patient. The process is a learning experience for both the FDA and the applicant company. Ultimately the FDA and the apphcant company have the same goal creation of a reliable device that will ensure safety and efficacy when used in a patient. 

The planning and preparation of either a new product or investigational product application requires a multidisciplinary approach. Most companies developing new products utilize formal project management systems to facilitate the collaboration between the technical disciplines, which may include personnel from research and development, manufacturing, formulation development, regulatory affairs, quality assurance, and other disciplines, as required. In addition to planning for the required elements, most FDA review divisions have specific preferences on how data should be analyzed and presented. When complex applications are planned, such as INDs, IDEs, PMAs, NDAs or BLAs it is critical for communications with the... 

Effective communication, both within the applicant s organization and with the FDA review team, is an integral part of planning any submission. It has been demonstrated consistently that the success of a new product application is dependent on the effectiveness of the organization s submission team and the working relationship developed between this group and the agency review team. 

The communication plan included direct interaction with the FDA review team to work through the issues early in the preparation of the NDA. 

Any consideration of these actions should also involve communications with the local district office and should address any other products or lots of the same product that may have similar problems. This approach accomplishes several things. First, it may serve to intercept an FDA seizure second, it will allow the firm to gauge the degree of FDA s concern. It may be that FDA was not really pursuing seizure, just seeking a responsible action on behalf of the firm s management. 

Test Account Setup and Approval. The account application is reviewed by the FDA ESG Administrator. The Administrator verifies that a letter of nonrepudiation agreement is on file, that the digital certificate conforms to the X.509 version 3 standard, and that all data fields in the Issuer and Subject fields are completed (see Appendix A, Digital Certificates for more information). The Administrator will also communicate with the Transaction Partner to confirm the application information. If these conditions are met, a test account is set up, and connections to the FDA ESG test system are established before the submitting organization is approved as a Transaction Partner. 

Communications between the FDA and applicants Dispute resolution Drags with potential for abuse Approval of an application and an abbreviated application... 

The information found in Table 39.1 was obtained from a variety of sources personal communications with the toxicologists who designed the programs, the FDA Web site, the EMEA Web site, and the package insert for the product... 

The issue of off-label information is certain to remain controversial for some time, with the FDA seeking ways to restrict the dissemination of off-label information about prescription drugs and the legal community and industry seeking ways to provide such information to health professionals without stimulating enforcement actions. 

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