OTCs (Over the Counter)

Safe, effective, and widely available, OTC medicines play a vital and cost-effective role in the United States. Over-the-counter (OTC) medicines, other than those approved by direct application, are marketed under regulations referred to as “OTC monographs,” and have been established through the FDA’s OTC Drug Review.

The FDA determines which active ingredients are generally recognized as both safe and effective (GRAS/E) for their intended uses. The FDA also issues “negative monographs,” which prohibit use in hundreds of specific indications for OTC drug ingredients. The FDA continues to evaluate the safety and effectiveness of OTC medicines.

We can assist you with the following OTC drug requirements:

• FDA Establishment Registration
• Drug Listings and Label Submissions
• U.S. Agent Requirement
• Authorizing Official Requirement
• Medical & Pharmaceutical translations

Label / Ingredient Reviews and Graphic Design

The TechLink International staff of translators and graphic designers has adapted hundreds of OTC labels. You provide the original information, and will receive from us an FDA-complaint version of your label, ready to be printed. Let the TechLink International consulting team put you on the path to compliance and open the door to new sales opportunities in the United States. Call us for more information.

Over-the-counter (OTC) Drug Monograph

OTC drugs are available for sale without prescription. There are several different categories for formulation, which include hundreds of active ingredients. Ingredients, doses, formulations, intended use and labeling have to be described on the monograph. Ingredients not yet cleared by the FDA cannot be used on the formulation, and must be subject to an OTC New Drug Review via NDA (New Drug Application). NDAs for prescription drugs and for OTC drugs are a completely separate procedure. If a drug is being sold as a prescription and will be sold as an OTC, it is necessary to present the FDA with a new NDA for the marketing change. In this case, a new monograph is not necessary.

Pre-Clinical Trials

Before a drug may be tested on humans, pre-clinical studies must be conducted sometimes in vitro but usually in vivo on animals to determine that the drug is safe. The FDA requires a “sponsor” for a pre-clinical trial, which is a pharmaceutical company, research institution, or other health organization that funds a clinical trial and designs its protocol.

Investigational New Drug (IND)

If the pre-clinical trial is successful and the sponsor determines that the product is reasonably safe and effective to be used in humans, the IND is the next step for the opportunity of commercial development. The IND is not an application for marketing approval. It is an application which details in vitro animal pharmacology, toxicology texts, clinical protocols and investigational information.

Clinical Trials (Human)

New Drug Application (NDA)–This is the formal step a drug sponsor takes to ask that the FDA consider approving a new drug for marketing in the United States. An NDA includes all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured, whether the drug is safe and effective for its proposed use(s), and whether the benefits of the drug outweigh its risks.

Drug Review Steps

1. Preclinical (animal) testing.
2. An investigational new drug application (IND) outlines what the sponsor of a new drug proposes for human testing in clinical trials.
3. Phase 1 studies (typically involve 20 to 80 people).
4. Phase 2 studies (typically involve a few dozen to about 300 people).
5. Phase 3 studies (typically involve several hundred to about 3000 people).
6. The pre-NDA period, just before a new drug application (NDA) is submitted. This is a common time for the FDA and drug sponsors to meet.
7. Submission of an NDA is the formal step asking the FDA to consider a drug for marketing approval.
8. After an NDA is received, the FDA has 60 days to decide whether to file it so it can be reviewed.
9. If the FDA files the NDA, an FDA review team is assigned to evaluate the sponsor’s research on the drug’s safety and effectiveness.
10. The FDA reviews information that goes on a drug’s professional labeling (information on how to use the drug).
11. The FDA inspects the facilities where the drug will be manufactured as part of the approval process.
12. FDA reviewers will approve the application or issue a complete response letter.