Emergency use authorization (EUA), conditional marketing authorization (CMA), and the precautionary principle at the...

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...

Standard precautions are the minimum infection control safeguards used while caring for all patients, irrespective of their disease condition. They help prevent the spread of common infectious microorganisms to healthcare workers, patients, and visitors in all healthcare settings.
Hand hygiene is the most crucial means to prevent the transmission of disease. Employers are legally required to provide their workers with personal protective equipment (PPE) to minimize exposure or contact with...

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...

Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...

Transmission-based precautions are for patients known to be infected or suspected to be infected or colonized with organisms that pose a significant risk to others. Some transmission-based precautions include contact, enteric, and droplet.
Contact Precautions:
Contact precautions are the measures taken to prevent the transmission of infectious agents, especially epidemiologically important microorganisms such as MRSA or influenza, primarily transmitted through direct or indirect contact with an...