The person screening your submission could email you to provide this missing element in an interactive review to avoid placing your submission on hold, but they are not required to give you a chance to provide this interactively by email. If you do receive an RTA Hold letter, you might be able to correct missing elements on the same day, but the k review clock is automatically reset when your k is placed on RTA Hold. The RTA checklist is the criteria that your submission is being evaluated against.
If your submission has deficiencies during the initial review against the RTA Checklist, the FDA will refuse to accept it and the substantive review will not begin until those deficiencies have been corrected.
Since the FDA does not hide what they are looking for, or how they will evaluate your submission, use that to your advantage. Assuming that you have correctly determined the type of k submission you have, perform a gap analysis of your submission against the RTA checklist.
The scope of the FDA guidance document that is provided for the benefit of the FDA personnel that are reviewing your submission and not specifically for the k submitter. It is also for the purpose of providing a loose framework for systematically reviewing submissions in a consistent manner.
This ensures all submissions receive equal nonbiased treatment. There are some things that this guidance document does not address or alter by its own admission. Other guidance documents address those issues. The most common is that your submission is poorly organized.
Either you did not provide a table of contents, your submission is not organized in accordance with the sections outlined in the guidance, or the pages of your submission are not properly numbered. If it were my decision, I would refuse to complete the entire checklist until you gave me a properly organized submission. The second most common reason for refusal is the submission of a device description that is not adequate. The FDA needs more detail than most companies provide for the device description because they need to understand what the differences are between your device and the predicate device.
This includes much more than just the indications for use. Who are the intended patients and users? What is the intended environment of use? What are the materials for patient-contacting components? What is the source of power for your device? Which design features does your device include when compared to the predicate?
What is the user interface for your device? Which accessory devices are needed with your device? You can even make the mistake of being inconsistent in your submission by not repeating the content in the device description in other sections of the k submission. It is important to duplicate certain content verbatim in other documents such as the k summary, the executive summary, the substantial equivalence comparison, and the instructions for use.
Paraphrasing and summarizing certain information will not work. Ramsey Baghdadi January 11, FDA lists six deficiencies that will likely draw an RTF, none of which should be surprising to sponsors: Materially lacking or inadequately organized applications. The application contains inadequate information for one or more indications when multiple indications are submitted in the same application.
That is unchanged from the version. Reliance on a single trial to support approval of an application without adequate justification, and particularly in cases where FDA already formally requested more than one trial, at the end of Phase 2 meeting, for example. Failure to submit an assessment of studies related to the potential abuse of a drug that are necessary to inform drug scheduling under the Controlled Substances Act and the development of drug product labeling.
Required content is not submitted electronically where the FDA has specified it must be. Create documents by bringing together templates and data. At scale. Legacy document transformation. Convert old file formats to the latest standard to ensure future use. Convert your audio and video files to the format of your choice.
How does the platform work? The basics. Connect all your systems, convert and enrich documents. Maximum scalability. How we scale to your fluctuating demands.
Discover what makes DocShifter 10x faster than comparable solutions. See how easy it is to connect to all your enterprise systems. Automated file format recognition. Supported file formats. Windows, Linux, Docker. On-premise or in the cloud. You choose. Keep your conversion services up and running at all times. See how rendering is used within your organization. Make smarter decisions based on data. About Us. Contact Us. Refusal to File RTF and how modern rendering can reduce non-compliance risk.
September 29, Related Topics. Patient safety is crucial in the Life Sciences industry There are high risks of taking any shortcuts in this long process. Filing for marketing authorization — is success guaranteed? What is refusal to file RTF? How can I avoid a refusal to file from FDA? What are the consequences of receiving a Refusal to file from the FDA? Fines imposed by the FDA. Stock price drops. This is another negative impact that contributes to the significant financial losses incurred after receiving an RTF from the FDA.
For example, there was the case with a pharmaceutical company that filed for marketing authorization of its new drug with the FDA in December Soon after this announcement, the stock prices plummeted by Negative press.
Ensuring patient safety is vital in the Life Sciences industry. And when that happens, the consequences can be truly catastrophic and it can really be the end of the new drug, long before being launched to the market. How can DocShifter help pharmaceutical companies achieve technical document compliance? Speed up time to market, reduce risk of non-compliance and save big. About DocShifter Speed, quality, scalability, and configurability are reasons why biotech, pharma and medical devices companies choose DocShifter to automate and simplify all their document conversion processes.
Filing for marketing authorization - is success guaranteed? Life Sciences , Press Release. Pharma time-to-market reduced thanks to more efficient submission document publishing services. PharmaLex, a leading provider of specialized services for the January 3, Read More. How to design or implement an enterprise file conversion platform? Enterprises deal with a lot of documents, in multiple formats June 30,
0コメント