The Clinical Data Interchange Standards Consortium (CDISC) created the standard. FDA SEND supports the approval process. SEND stands for the Standard for Exchange of Non-clinical Data. It’s vital to follow FDA SEND compliance regulation guidelines to streamline the approval process. The Study Data Tabulation Model(SDTM)is a standard for organizing and formatting data.
SEND involves the use of the SDTM for nonclinical studies. It’s a way to consistently collect and share nonclinical data. Moreover, the FDA requires applicants to use SEND standards. SEND increases the efficiency and quality of a scientific review. It also improves communication with the FDA. In the end, the purpose of SEND is to eliminate paper submissions.
Keep reading for a guide to FDA SEND compliance and its best practices.
CDISC created SEND in 2002. The consortium designed it specifically for the submission of nonclinical studies. The framework reduces the time regulators must spend going through reports. It helps them to find pertinent data faster.
In this way, SEND speeds up the development of drugs. As a result, it helps to reduce drug development costs.
At any stage during a study, a lab may need to communicate with the FDA. As a result, it’s critical to consider SEND policies as early as during the planning stage of the study. Sponsors must manage the receipt, review, and submission of data. They must also work within a framework for archiving information.
You must communicate effectively with your sponsoring company. This will help them fulfill their responsibility to submit datasets correctly. SEND also helps sponsor companies to meet Electronic Common Technical Document (eCTD) submission requirements.
SEND offers many benefits. It reduces data entry greatly. It also accelerates the review process.
You can use SEND to support the use of existing visuals for standardized datasets. It also enables cross-study analyses and visualization. Furthermore, it allows for comparison, despite the sponsor or lab facility.
The FDA recognizes that effective and timely communication during an investigational new drug application is vital. It gives sponsors needed information. It also informs the design of trials and studies. Information from the FDA also informs product quality information. Furthermore, it supports approval for future FDA marketing applications.
The FDA tries to respond to questions quickly. At the same time, however, the agency must balance public health, regulatory, and other obligations.
The SEND standard streamlines information processing. It helps the FDA meet these goals. Let’s look closer at FDA suggestions for specific kinds of SEND communications.
The FDA suggests that formal meetings are useful to sort out questions that come up during the lifecycle of R&D. There are important reasons why a sponsor may want to speak with the FDA in person.
The agency can provide valuable regulatory and scientific advice. This information can result in more efficient and robust R&D.
Formal meetings can also help sponsors better understand the evidence needed for their applications. This evidence might include:
Sponsors must understand the FDA’s perspective. Sponsors need feedback from the FDA about appropriate requirements for evidence and compliance. Furthermore, they need this information in advance of FDA marketing applications. In this way, formal meetings can help sponsors develop an efficient R&D program.
You may have a complex scientific, technical, policy, or regulatory question. In that case, the FDA recommends a request for a formal meeting. Alternatively, you can pose your question in a formal submission.
The FDA recommends that regulatory project managers (RPMs) should establish letter templates when communicating with the agency. Templates will ensure accuracy and consistency in communications.
The agency also recommends that RPMs send courtesy copies of written correspondence to sponsors. They should use secure email when doing so if the correspondence references regulatory actions.
This kind of action may include a clinical hold. The FDA also recommends that RPMs use secure email when they have time-sensitive questions. In some cases, an RPM can’t set up a secure email with a sponsor. If so, they should send a courtesy notice by fax.
Investigational new drug development takes significant time. During that time, a sponsor company needs to send an assortment of submissions to the FDA. Each of these submissions requires varying degrees of feedback, review, or response.
Some submissions are administrative. For instance, they might include:
Other submissions may center around patient safety. Yet others could describe clinical or nonclinical trial plans.
With this in mind, sponsors must adhere to timelines for their submissions. They must also follow timelines when submitting a new protocol amendment. The same applies when a sponsor adds an investigator to complete a previously submitted protocol.
RPMs must send a written acknowledgment and receipt of submission. These submissions include those that have review timelines. A charging request is an example of this kind of submission.
Regulatory project managers must provide acknowledgments within three business days. This advice applies to calls, emails, and other submissions from sponsors. The acknowledgment can even include the response.
Likewise, sponsors should acknowledge the receipt of information requests from the FDA. They should also provide the FDA with an estimated response time.
Sponsors should use secure mail when communicating with the FDA. Furthermore, the email service should allow for complete and transparent communication. However, secure email isn’t a substitute for formal submission.
Sponsors should submit formal paper submissions to the appropriate document room. Alternatively, they can use an official electronic gateway if it’s available. When using unsecured email, sponsors can’t include confidential commercial information. This information might include trade secrets, manufacturing, or patient information.
It’s vital to establish secure email with the FDA. Sponsors can request a secure email by contacting the FDA’s Office of Information Management and Technology (OIMT).
It’s acceptable for FDA RPMs and sponsors to communicate via phone. In some instances, however, they must discuss complex, regulatory, or technical issues during the conversation. In that case, the caller should follow up with a written record.
The record should document the discussion. It might also respond to information requested during the phone conversation. Even if you documented a call on the administrative record, however, it’s not a substitute for formal submission.
In some cases, it’s not possible to establish a secure email between a sponsor and the FDA. Again, secure email is not a substitute for formal submission. You should submit any form of submission through the proper channels. However, you can use a fax to communicate in the absence of secure email if needed.
Sponsors and RPMs should contact a fax recipient before transmission. They should arrange for a fax receipt confirmation before sending the document. The FDA and sponsors receive a high volume of faxes. This practice ensures the recipient won’t overlook the fax.
You should always include a cover sheet with your faxes. A cover sheet will ensure accurate and timely routing.
Hopefully, our guide to FDA SEND compliance will help you to streamline your lab communications with the Food and Drugs Administration.
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