the u. s. food and drug administration is an example of whose interest in health care course hero

What is the food and Drug Administration responsible for?

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA also provides accurate, science-based health information to the public.

Which government agency has the responsibility of enforcing drug standards?

Mar 23, 2021 · For general questions, or if you are unsure of who to contact, contact the Patient Affairs Staff at 301-796-8460 or [email protected]. 2. After 4:30 p.m. ET …

What is the role of the FDA in public health?

Sep 22, 2020 · Digital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses. These technologies span a wide range of uses, from applications in ...

What does the FDA’s authorization mean for the health of Americans?

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease …

What is the phone number for FDA?

Investigational medical devices: 301-796-7100 or [email protected] [CDRH's Division of Industry and Consumer Education] Investigational biologics: 240-402-8020 or 800-835-4709 or [email protected] [CBER's Office of Communication, Outreach and Development]

What time does the FDA open for emergency calls?

2. After 4:30 p.m. ET weekdays and all day on weekends. For emergency requests for all medical products (drugs, biologics, and medical devices) contact FDA's Emergency Call Center at 866-300-4374. Report from the 2018 external assessment of the Expanded Access Program.

When is expanded access appropriate?

Expanded access may be appropriate when all the following apply: Patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition. There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.

What is expanded access?

Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

What is the FDA's focus on digital health?

The FDA’s Focus in Digital Health. Many medical devices now have the ability to connect to and communicate with other devices or systems. Devices that are already FDA approved, authorized, or cleared are being updated to add digital features. New types of devices that already have these capabilities are being explored.

What is the CDRH?

As another important step in promoting the advancement of digital health technology, CDRH has established the Digital Health Center of Excellence which seeks to empower digital health stakeholders to advance health care.

How can digital health be used to improve health care?

These technologies can empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional health care settings. Providers and other stakeholders are using digital health technologies in their efforts to: 1 Reduce inefficiencies, 2 Improve access, 3 Reduce costs, 4 Increase quality, and 5 Make medicine more personalized for patients.

How can digital health technologies help patients?

Patients and consumers can use digital health technologies to better manage and track their health and wellness-related activities.

What is digital health?

Digital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses. These technologies span a wide range of uses, from applications in general wellness to applications as a medical device.

How does technology change our lives?

The use of technologies, such as smart phones, social networks, and internet applications, is not only changing the way we communicate, but also providing innovative ways for us to monitor our health and well-being and giving us greater access to information.

When does the FDA issue an EUA?

On the basis of the determination by the Secretary of the Department of Health and Human Services on Feb. 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and issued declarations that circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.

What is the EUA for Moderna?

Español. Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S.

How old do you have to be to get Moderna?

The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers ...

Is Moderna effective?

The totality of the available data provides clear evidence that the Moderna COVID-19 Vaccine may be effective in preventing COVID-19. The data also show that the known and potential benefits outweigh the known and potential risks—supporting the company’s request for the vaccine’s use in people 18 years of age and older.

What is a human subject?

According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or: Obtains, uses, studies, analyzes, or generates identifiable private information.

What is the only record linking the subject and the research?

The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. As part of the consent process, the federal regulations require researchers to: Provide potential subjects with information at the appropriate reading comprehension level.

What does the IRB have to ensure?

The IRB must ensure that: Confidentiality of the prisoners' health status is maintained. You learn that one of the subjects from your study will be admitted to prison next week. You assert that it is in the best interest of the subject to remain in the study while incarcerated.

What is behavioral research?

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the researcher's car on the way home from work.

What is the purpose of a focus group?

A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery.

What is a consent document?

A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

What is a therapist at a free university clinic?

A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project.