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Guide to FDA IND meetings and applications

29 September 2021

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Guide to FDA IND meetings and applications

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Guide to FDA IND meetings and applications

FDA IND applications are a crucial milestone for pharmaceutical companies seeking to bring new drugs into the American market. IND, or Investigational New Drug, applications are the opportunity for you to demonstrate to the Food & Drugs Administration that your medicinal product is safe, compliant and suitable for testing in humans. A successful IND application means your investigational product is approved for use in clinical trials and for transportation across state lines within the United States.

Pre IND meeting with the FDA

For support you on your way to clinical and market approval, you may find it useful to get guidance and support from the FDA at the critical ‘Pre-Clinical Development’ stage of the application. 

Pre-IND programmes and meetings can be used to get any questions answered, and it’s recommended that multiple people in your organisation review your data collection as it’s being built for any gaps or omissions.

The FDA offers two programmes to guide and accelerate your IND processes:

These programmes are designed to establish an effective working relationship between your organisation and the FDA, and will usually make the IND submission and review stages quicker and easier.

Checklist for your pre-IND meeting with the FDA

In this step-by-step checklist, we cover the essential things you need to know about filing your IND application and arranging a meeting with the FDA.

Download checklist

 

Types of FDA IND application

There are multiple types of IND application. Broadly speaking, your IND will be either 1) commercial or 2) research – depending on whether you intend to submit a marketing application afterwards or not.

There are then three IND ‘types’ underneath this broad categorisation:

  • Investigator IND, for investigation of an unapproved drug. The most common IND type.
  • Emergency use IND, for quick authorisation of a drug for use in an emergency situation (such as the COVID-19 pandemic) when no alternative treatment exists
  • Treatment IND, for drugs already in the clinical stage which are showing effectiveness in treating serious conditions

Around a third of IND applications relate to biopharmaceutical products. Two thirds relate to small-molecule drugs.

 

Filing an IND: when should you begin your IND process?

Ultimately, the IND stage begins once your pre-clinical activities are concluded. That means you should:

  • Be confident in the strength and integrity of your product performance, and ready to take it into the human testing stage. 
  • Have sufficient proof-of-concept data to present to the FDA to attest to your product’s safety and efficacy so far

The IND submission process is like any other regulatory hurdle: you’ll need documented information, and lots of it. Replicable results, performance hypotheses and activity analytics are all solid and reassuring data that the FDA will expect to see in tandem with demonstrable GxP operation on your part.

 

Key pieces of IND submission data include:

  • Toxicology and pharmacology data from animal testing
  • Storage and stability data
  • Manufacturing information showing how you intend to manufacture your product at scale and with sufficient quality
  • Clinical research plans and clinical protocols to assess potential risk to humans
  • Target clinical indication to contextualise your submission

GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) benchmarks should underpin all the data you submit to the FDA.

 

IND submissions

So you have all your pre-clinical data and are ready to proceed to clinical development. The IND submission stage begins.

Your collected data should be submitted in triplicate to the FDA alongside three supplementary forms. The FDA then has 30 days to review and reject your product. In the case of approval, or simply a lack of rejection in the 30-day timeframe, your product has the green light to progress to the clinical testing stage and may be transported to clinical investigators in different states.

 

 

Managing your IND application

 Managing, controlling and co-authoring your IND data pack can be a long and complex task that distracts you from your core product development work.

Needless to say, organisations going through the IND submission process do make mistakes – and common errors have emerged as recurring blockers of the process.

 

As we can see from this graph, in the FDA’s 2020 fiscal year it received 6,954 IND submissions (blue) and took 7,603 actions (yellow) against them – meaning that on average, every single IND submission required a corrective FDA response within the 30-day timeframe, with about 9% requiring more than one response.

A controlled right-first-time approach is therefore a great way to impress the FDA and accelerate your route to the clinical stage.

In the past five years, the three most common reasons for IND data pack rejections have been:

  • Submission mistakes: missing documents or incorrect eCTD formats
  • Disorganised and unclear data that the FDA simply cannot process and digest within 30 days
  • Unfocused and irrelevant data that doesn’t support your clinical protocol or adequately explain potential risks

These mistakes are compounded and multiplied by outdated document creation and review techniques, with multiple uncontrolled versions circulating simultaneously by email or spreadsheet. For multi-site and international organisations, coordinating relevant stakeholders and establishing a clear and cogent route to submission can be a serious challenge.

How to mitigate and minimise these mistakes:

Document collaboration systems such as PleaseReview are becoming increasingly adopted and invaluable tools for life science organisations looking for effective and painless IND submissions.  

Use PleaseReview’s cloud-based co-authoring functionality to:

  • Invite stakeholders in your organisation to collaborate on single, centralised, shared versions of IND documents, wherever you’re based.
  • Flag mistakes, fix omissions and make comments together.
  • Access complete audit trails and histories of all document changes and revisions.
  • Produce high-quality FDA IND documents and review them collaboratively with 65% shorter review times.

Accelerate your FDA IND application with PleaseReview

Join the industry standard and discover how PleaseReview could transform the way that your company collaborates on complex documents such as FDA IND applications.

Download PleaseReview Success Stories
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Written by

Nicola Pearson

With a background in research, Nicola Pearson is a blogger on all things business, financial and technology. She is passionate about the topics of wellbeing, leadership and collaboration in the workplace. She enjoys hiking, travelling and yoga in her spare time. 

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