Next Upcoming Seminar: Food Labeling Compliance Seminar – April 3-4, 2017

Specializing in FDA Regulatory Matters

Investigational New Drugs

EAS Consulting Group, LLC. assists clients in obtaining the necessary permissions to perform testing of Investigational New Drugs in human clinical trials as well as consult with FDA on your company’s applications. EAS can also assist in the design of the clinical study.

FDA’s role in the development of a new drug begins when the drug’s sponsor (usually the manufacturer or potential marketer), having screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans.

At that point, the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system. Sponsors who are testing their Investigational New Drugs (IND) may wish to do so in multiple states, requiring an exemption to federal laws which require that drugs transported across state lines have an approved marketing application.

An exemption allowing for this transportation can be sought from FDA under 21CFR Part 312 allowing the IND to be transported across state lines, and thus allowing for the preclinical determinations of safety prior to approvals and commercial development.

There are three IND types:

  • An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.  A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
  • Emergency Use INDallows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with  21CFR , 312.23 or Sec. 312.34.  It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.
  • Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.

The IND application must contain information in three broad areas:

  • Animal Pharmacology and Toxicology Studies – Preclinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans.
  • Manufacturing Information – Information pertaining to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product.
  • Clinical Protocols and Investigator Information – Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks.

Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials.  During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.

EAS can assist with the preparation and submission of the Pre-IND meeting request, briefing package, meeting preparations. Also, we can prepare and manage the IND application and for foreign companies act as the appointed U.S. Agent.