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Tips To Follow And Mistakes To Avoid In The FDA Investigational New Drug Process – Food and Drugs Law


The Investigational New Drug Application or IND is a key step
in this journey. The IND application is the process by which a new
drug sponsor must receive approval from the Food and Drug
Administration (FDA) to begin clinical testing on human subjects.
IND approval also serves an important legal function in permitting
sponsors to transport an investigational new drug across state
lines for clinical trials.

The IND approval process is rigorous and for good reason.
Human safety and lives are at stake.

Effectively navigating the IND application process requires
early preparation and securing the right expertise when needed.
Here, we’ll look at the process in more detail:


An IND is required for any clinical investigation that
involves administering a drug or biologic to humans and that is not
exempt from IND requirements.

A drug generally
includes any article that is intended for the “diagnosis,
cure, mitigation, treatment, or prevention of disease” and is
also intended to “affect the structure or any function of the
body.” Supplements and food products can be considered a
“drug” if they are used in an unconventional way to
affect, cure, mitigate, or prevent a disease by affecting a
structure or function of the body. Biological
products also require IND approval and include, among other
products, cytokines, monoclonal antibodies, growth factors, gene
therapy products, allergenic extracts, and bacterial
Exemptions to
the IND requirements include certain research with already approved
drugs where there is no intent to use the investigation to support
a new indication, no significant labeling changes, and no
significant change in advertising. Exemptions also apply for
studies to compare unapproved generic versions of a drug with
approved drugs and for human research studies involving radioactive
or cold isotopes. Dietary supplements are generally not considered
a drug and fall outside of the IND requirements.


The review and approval process is overseen by the FDA’s
Center for Drug Evaluation and Research (CDER) and Center
for Biologics Evaluation and Research (CBER), depending
on whether the product is a drug or biologic. While the FDA
distinguishes between commercial IND’s and those sought solely
for research purposes, the same requirements apply equally to both
categories of applicants. The IND application requires sponsors to
provide information on three broad fronts, including:

  • Animal Toxicology and Pharmacology
    —Preclinical data from animal studies that
    indicate the drug is reasonably safe for testing in humans. This
    may also include other experience with the drug in humans (i.e.
    foreign use).

  • Chemistry, Manufacturing, and Controls
    —Information that ensures the sponsor company can
    produce and supply the drug to market with consistency.

  • Proposed Clinical Study Protocols and Investigator
    —Detailed clinical study protocols,
    information on the qualifications of the investigator who will
    oversee the clinical trial, and assurances to obtain informed
    consent from research subjects and to obtain the study’s review
    by an appropriate institutional review board (IRB).

Once the IND is submitted, the FDA has 30 days to either
approve the product for clinical trials or otherwise place the IND
on a “clinical hold.” If the study is placed on hold, the
sponsor must suspend the proposed clinical trials to address
potential issues. The IND application must then be re-submitted and
the review process starts over again.

Once IND approval is received from the FDA, the sponsor can
begin testing with human participants. Clinical testing occurs in
three distinct phases:

Phase 1 testing is conducted on a small
number (20-80) of healthy participants to determine the basic
pharmacological and toxicological effects of the drug on

Phase 2 testing is administered to a larger
group of patients (100-300) with the disease or condition that is
targeted by the new drug. A key focus of this phase is to determine
the drug’s effectiveness, side effects, and its optimal dosage
and administration.

Phase 3 testing involves testing the drug
against a placebo with a larger number of participants (up to
3,000) from the patient population for which the drug is to be
used. Phase 3 testing is typically carried out over a longer time
period to establish a larger body of clinical evidence and to
assess labeling concerns. Importantly, data gathered during Phase 3
studies inform the FDA’s ultimate risk-benefit analysis in the
New Drug Application (NDA) approval process.

The clinical trial process continues until the sponsor decides
to end the trials or files a new drug marketing application (NDA)
to take the drug to market. A successful NDA will heavily depend on
a well-designed clinical trial that ensures the study reaches
clinical endpoints. Knowledgeable planning of the clinical trials
can also reduce the risk of a clinical hold during trials, as the
FDA can issue a clinical hold at any stage of the clinical trial
process if concerns arise as to the safety or efficacy of the drug,
the adequacy of clinical protocols, or CMCs. At Crowley Law LLC, we
work with a network of highly experienced contract research
organizations who are experts at planning and conducting clinical
trials to maximize NDA success.


Setbacks at the IND application stage are often costly and can
significantly delay getting a product to market. Yet aside from
simply having a poor study design, many IND application problems
can be avoided with thoughtful evaluation and planning.

Let’s take a look at the most common reasons that clinical
trials are delayed.

1) Poorly Written and Organized

The FDA receives hundreds of original INDs each
year—reviewers have little time to waste. It is incumbent
upon applicants to make sure their application is well-organized,
clear, and to the point. Your application should include relevant
and adequate data to support clinical protocols, labeling claims,
and safety assurances.

At the same time, too much data that has little direct
relevance to your proposed study can make it cumbersome and
time-consuming to sort and make sense of your application package.
When writing your IND, keep in mind how your application can best
be streamlined to ease the job of reviewers.

2) Technical and Grammar Mistakes

Since May of 2018, the FDA has required all commercial INDs to
be submitted through its Electronic Common Technical Document
(eCTD) portal. Sponsors who are unfamiliar with the FDA’s
electronic submission process often make inadvertent mistakes that
can cause their application to be rejected. These can include
things like formatting errors or failing to include required
documents. It’s also important to carefully review your
submission for grammar, spelling, and formatting mistakes. This
will make your reviewer’s job easier and ultimately increase
your odds of success.

3) Not Seeking FDA Guidance

The FDA recognizes that the IND process can be daunting,
especially for smaller companies with limited resources and
experience with the IND process. In such cases, the FDA highly
encourages sponsors to take advantage of its Pre-IND Consultation
Program. The program allows new drug sponsors to request early
dialogue with the FDA and is a key first step in establishing your
reputation and communication channels with the agency. More
specifically, the Pre-IND meeting can help a sponsor verify that it
is using the appropriate animal model to determine product safety,
that toxicology data supports clinical trials, and to discuss
specific roadblocks or data concerns.

The Pre-IND meeting can be especially helpful in situations
where a drug is new, has a novel indication, or treats a
life-threatening or serious disease. The Pre-IND meeting is also
important where the sponsor is new to drug development or has
particular questions for which there is little existing FDA
guidance. Existing FDA guidance and instructions should be
thoroughly consulted before seeking a pre-consultation meeting to
ensure the meeting is necessary and that meeting time is


Pre-IND Meeting Request

Sponsors must file a formal request to schedule a Pre-IND
meeting. Meetings are typically scheduled within 60 days of the
request. To facilitate meeting outcomes, FDA guidance suggests that the meeting
request include the following information:

  • The meeting objectives and a proposed agenda

  • A list of specific questions categorized by discipline

  • Proposed sponsor and FDA participants

  • Proposed meeting date (usually 6-8 weeks out)

  • When the background packet will be submitted (at least 4 weeks
    from the meeting date)

  • Information about the quantitative composition of the drug,
    proposed indication, and dosing regimen

Preparing the Pre-IND Meeting Packet

The Pre-IND meeting is the first time the FDA will have eyes
on your study. It serves as a preliminary test run for how your IND
will be received by the agency. As such, your pre-meeting packet
must provide adequate information to inform the FDA’s feedback.
Along with an overall program synopsis, your pre-meeting packet
should include industry data, CMCs, and information about the IND
product characteristics, including animal testing and toxicology
data. The FDA also requests that you include a copy of the initial
meeting request with current and updated information.

Preparing for Your Pre-IND Meeting

Sponsors should strive for total transparency and full
disclosure throughout the Pre-IND meeting process. This will help
to both improve meeting outcomes and establish your credibility
with the agency. And credibility with the agency is essential for
your success.

Ultimately, the focus of the Pre-IND meeting is to expose your
scientific data in a neutral way and get FDA feedback on their
specific concerns. Ask good questions and listen to the FDA’s
response. An experienced consultant can help you prepare so you get
the most out of your Pre-IND meeting.

Navigating the FDA approval process for new drug therapies can
be difficult and time-consuming. The IND application process is a
tremendous investment in time and resources and requires careful
and informed planning. A skilled and experienced attorney who has
an understanding of the FDA and how to navigate the application and
review processes can help streamline the IND application

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.

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