Year: 2026
Type: article
Abstract: A pharmaceutical company trying to manufacture a drug, cosmetic, vaccine, or medical device must first establish its safety and efficacy. This is done by conducting preliminary investigations in animals, followed by establishing clinical efficacy through clinical trials. This whole process spans years before the FDA or other regulatory bodies approve the drug or vaccine for marketing and distribution. In situations involving public health emergencies, pandemics, or potential threats such as chemical, biological, or nuclear incidents, the FDA allows for Emergency Use Authorisation (EUA). This regulatory approach allows for fast-track authorization of unapproved medical products or unauthorized indications of medical products. The FDA also allows the use of EUA when there are no adequate alternative treatment options available.EUA acts as an essential resource for medical practitioners and healthcare professionals during a public health crisis by using all possible medical products and treatments available during the emergency period. The EUA is activated once the government declares a crisis and remains in effect until the end of the said specific crisis it was activated for. For a medical product or treatment to be approved by the EUA, it must be “safe and effective,” and its potential benefits must outweigh its potential risks.
Source: Acta Pharma Reports.
Authors: Trapti Saxena, Maleeha Masood, Rudra Vaishno
Institution: G. Pulla Reddy College of Pharmacy
Language: English
Topic: Healthcare Regulation
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W7159667481