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- Written by: DigiTrends4U.com
- Category: Health Care
Development and Regulation of OTC (Nonprescription) Drug Products
Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through the New Drug Application (NDA) Process. FDA's review of OTC drugs is primarily handled by the Center for Drug Evaluation's Office of Drug Evaluation IV.
OTC Drugs Developed Through the NDA Process
A sponsor seeking to market its product OTC, either as a new NDA or as a switch from a prescription product, applies to the Division of Nonprescription Drug Products (DNDP) in the Office of Drug Evaluation IV. DNDP will oversee drug development, including the review and regulatory action on Investigational New Drugs (INDs), and may obtain input from the specific subject matter review division (SSMRD) during the development process. After a sponsor submits an NDA, DNDP reviews the consumer studies, the post marketing safety data, the OTC labeling, and any regulatory issues. The SSMRD collaborates with DNDP (see MAPP 6020.5 Good Review Practice: OND Review Management of INDs and NDAs for Nonprescription Drug Products) and typically provides review of the efficacy and safety data related to controlled clinical trials. Additional input is obtained as needed from other disciplines outside of DNDP, including clinical pharmacology, statistics, and chemistry.
Read the full article in U.S. Food & Drug Administration (FDA) website
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- Written by: DigiTrends4U.com
- Category: Health Care
Abstract
The term liquid biopsy is used in contraposition to the traditional “solid” tissue biopsy. In the oncology field it has opened a new plethora of clinical opportunities as tumor-derived material is shedded into the different biofluids from where it can be isolated and analyzed. Common biofluids include blood, urine, saliva, cerebrospinal fluid (CSF), pleural effusion or bile. Starting from these biological specimens several analytes can be isolated, among which we will review the most widely used: circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), circulating tumor RNA (ctRNA), proteins, metabolites, and exosomes. Regarding the nature of the biomarkers it will depend on the analyte, the type of tumor and the clinical application of the liquid biopsy and it includes, somatic point mutations, deletions, amplifications, gene-fusions, DNA-methylated marks, tumor-specific miRNAs, proteins or metabolites. Here we review the characteristics of the analytes and the methodologies used for their isolation. We also describe the applications of the liquid biopsy in the management of patients with cancer, from the early detection of cancers to treatment guidance in patients with advanced tumors. Finally, we also discuss some current limitations and still open questions.