Submission process

Schools also like the online submission process because they find it is safe and secure. Applications can t get lost in the mail. As soon as you access an online application, your progress may be tracked, so the school to which you are applying knows when you have begun the process, when you have finished, and when you have submitted the application. For example, the University of Michigan s website asserts that every submitted online application was received by our office last year with the data intact and loaded directly into our student information system, with the... 

Ensure formalized change management procedures are in place during the submission process. 

Think of the submissions process as a major exam but one for which you have the questions in advance, can use your notes, and—on hopefully rare occasions—can retake the test if necessary. 

Examine electronic submission options. Most FDA submissions can be made manually (paper) or electronically. Obviously, the electronic submission process is more efficient, particularly when delivering large documents (INDs routinely run over 5,000 pages NDAs may be even larger), ffowever, there are some additional considerations. 

The submissions process can be traumatic. Whether you are a start-up company filing your first meeting request or a major pharmaceutical organization with an NDA for the latest blockbuster, there is a great deal resting on the process and the result. 

For meeting requests, orphan-drug applications, INDs, NDAs, 505b(2) NDAs, Abbreviated New Drug Applications (ANDAs), Orphan Annual Reports, and Annual Reports, the tools, checklists, and FDA guidelines are provided. With this tool kit, your organization can regain control of a rational, predictable submissions process. 

The electronic submission process is defined as the receipt, acknowledgment, routing, and notification to a receiving center of the receipt of an electronic submission. In this definition,... 

The objective of this User Guide is to provide industry participants with information and guidance on how to prepare and send documents through the FDA ESG. A list of submissions that the FDA ESG will accept is given in Table 1.2. This document provides a high level description of the electronic submission process via the FDA ESG. 

TABLE 1.5 Submission process aspects and help and information contacts... 

Help and Information. There are resources that can be contacted if you need assistance with various aspects of the submission process. These are provided in Table 1.5. 

The steps for the electronic submission process for FDA ESG Web Interface users are provided in the following sections. 

The Submission Process When a submission is sent by using the FDA ESG Web Interface, it goes through the following steps. 

The responses to these challenges fall into three general categories, each resulting in modifications in the drug submissions process. FDA responses will likely fall in the general realm of outsourcing, industry responses will require diversification, and the responses of the various publics will all require enhanced information. ... 

The clinical batch record should be reviewed for GMP compliance and documentation requirements. The biobatch and stability batch records should be reviewed for equivalence to the information included in the NDA/ANDA submission. Process controls, specifications, bioequivalence data, and other information supported with foreign data should be submitted with a certified translation of that data. 

In the last 15 years, the size of a typical new drug application has grown from thousands of pages to several hundred thousand pages. To cope with this and to help speed up the submission process, a number of software tools have been developed. These tools provide control and access to documents in a collaborative... 

For all other biological products, sponsors must submit two applications, an establishment license application (ELA) and a product license application (PLA). Both submission processes (BLA or ELA/PLA) may require nonclinical and clinical data, chemical and biological information, and information on the product manufacturing process and facility. Ultimately, the single-application... 

Last but not least, point 6 in Fig. 40.4 shows the importance of long-term stability tests of the drug product. Often together with the carcinogenicity studies their availability trigger the submission process and therefore they are project-wise on the critical path. 

The Local sequence identifier is most prominently used in the data submission tool Sequin (see Chapter 4). Each sequence will eventually get an accession, version identifier and a gi number, but only when the completed submission has been processed by one of the public databases. During the submission process, Sequin assigns a local identifier to each sequence. Because many of the software tools made by NCBl require a sequence identifier, having a local Seq-id allows the use of these tools without having to first submit data to a public database. 

The submission process is governed by an international, collaborative agreement. Sequences submitted to any one of the three databases participating in this collaboration will appear in the other two databases within a few days of their release to the public. Sequence records are then distributed worldwide by various user groups and centers, including those that reformat the records for use within their own suites of programs and databases. Thus, by submitting a sequence to only one of the three major databases, researchers can quickly disseminate their sequence data and avoid the possibility that redimdant records will be archived. 

The submission process is quite simple, but care must be taken to provide information that is accurate (free of errors and vector or mitochondrial contamination) and as biologically sound as possible, to ensure maximal usability by the scientific community. Here are a few matters to consider before starting a submission, regardless of its form. 

The inclusion of the protein sequence serves as an important, if not essential, validation step in the submission process. 

Proteins include the enzyme molecules that carry out many of the biological reactions we study, and their sequences are an intrinsic part of the submission process. Their importance, which is discussed in Chapter 2, is also reflected in the submission process, and this information must be captured for representation in the various databases. Also important are the protein product and gene names, if these are known. There are a variety of resources (many present in the lists that conclude these chapters) that offer the correct gene nomenclature for many organisms (cf. Genetic nomenclature guide, Trends in Genetics, 1998). 

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