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An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. (Source: Drugs@FDA Glossary of Terms)

A 510(k) device refers to a device classified under Section 510(k) of the United States Food, Drug, and Cosmetic Act (a.k.a. Premarket Notification).  A device that reaches market via a 510(k) notification must be "substantially equivalent" to a predicate device on the market.  A device that reaches market via the 510(k) process is not considered to be "approved" by the FDA. Nevertheless, it can be marketed and sold in the United States. They are generally referred to as "cleared" or "510(k) cleared" devices.

ICH-GCP is a commonly used abbreviation for the ICH Harmonised Tripartite Guideline on Good Clinical Practice E6

The objective of the ICH GCP Guideline is to provide a unified standard for the European Union (EU), Japan and the USA to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

A CRA is a professional who, regardless of job title, monitors the administration and progress of a clinical trial on behalf of a sponsor. The sponsor, whose intent is the research of pharmaceuticals, biologics, and/or devices, may employ these individuals either directly or indirectly (via CROs or independent consultants/contractors). The CRA must be independent of the investigative staff conducting the research at the site or institution, and should not be employed or supervised by the investigative site or the institution.

An AE (Adverse Event)/ADR (Adverse Drug Reaction) whose nature, severity, specificity or outcome are not consistent with the information in the global core product information.

Please note that AEs/ADRs are classified in the pharmacovigilance database, according to whether they are considered to be included in the following global reference documents:

An inspection is conducted by a regulatory authority(ies) whereas an audit is conducted by the sponsor's auditor.

According to ICH-GCP, an inspection is an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial (under scrutiny) and that may be located at the site of the trial, at the sponsor's and/or contract research organization’s (CRO’s) facilities, or at other establishments deemed appropriate by the regulatory authority(ies) - see ICH GCP §1.29.