Bringing new nebulizer technologies to market: regulatory issues

Robert J Meyer1

  • 1Office of Drug Evaluation, Center for Drug Evaluation and Research, United States Food and Drug Administration, Parklawn Building, 5600 Fishers Lane, Rockville MD 20857, USA.

Respiratory Care
|November 12, 2002
PubMed

Related Concept Videos

Inhaled Medications01:23

Inhaled Medications

Inhaled medications are crucial for managing chronic obstructive pulmonary disease (COPD) and asthma. They are essential for effective treatment and control, ensuring optimal respiratory health and well-being. Inhaled medication delivers drugs directly to the lungs, providing a rapid onset of action and reducing systemic side effects compared to oral or injectable medications. Three primary types of inhalation devices are used to administer these medications: nebulizers, metered-dose inhalers...
Mechanical Ventilation III: Noninvasive Ventilation01:23

Mechanical Ventilation III: Noninvasive Ventilation

Noninvasive positive-pressure ventilation (NIPPV), continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) are essential methods in respiratory care. These ventilation techniques offer unique benefits for patients with various respiratory conditions, providing adequate support without requiring intubation. Let's explore how each method is crucial in improving patient outcomes and enhancing respiratory therapy.
Noninvasive Positive-Pressure Ventilation (NIPPV)
Oxygen Delivering System II: Venturi Mask and Transtracheal Oxygen01:16

Oxygen Delivering System II: Venturi Mask and Transtracheal Oxygen

Oxygen therapy is a pivotal aspect of medical care, particularly for patients with respiratory ailments. Two prominent oxygen-delivering systems include the Venturi mask and the transtracheal oxygen catheter.
Venturi Mask
The Venturi mask, named after the Venturi effect, is designed to deliver precise oxygen concentrations. It consists of a large tube with an oxygen inlet that narrows down, causing a pressure drop that pulls air in through adjustable side ports. The mask is a lightweight,...
Drug Regulation01:25

Drug Regulation

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...
Asthma-IV: Diagnostic and Management01:30

Asthma-IV: Diagnostic and Management

The diagnosis and management of asthma are comprehensive, encompassing clinical assessments, lung function tests, and pharmacological interventions. Here's an overview:
Clinical Assessment for Asthma:
This is the first step in diagnosing and managing asthma. It includes:
Oxygen Delivering System I: Nasal Cannula and Face Mask01:26

Oxygen Delivering System I: Nasal Cannula and Face Mask

The human body requires oxygen to function, and when the natural process of respiration is hindered, external devices, including the following, are needed to help deliver this vital gas.
Nasal Cannula
A nasal cannula is a lightweight tube split at one end into two prongs and placed in the nostrils. It is typically used to deliver low to medium levels of oxygen.
Suggested flow rate: The suggested flow rate for a nasal cannula typically ranges between 1 and 6 L/min.
Oxygen percentage setting:...