Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 - FDA.gov

• Respected FDA GMP online training courses and programs by SkillsPlus International Inc. 

According to the article:

The "U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset."

Read the full source article: Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 - FDA.gov

CDC Recommends One-Shot Johnson & Johnson COVID-19 Vaccine After FDA Authorizes Emergency Use - People

• FDA GMP Online Training - respected CGMP online training courses provided by SkillsPlus International Inc. 

According to the article:

"The vaccine from Johnson & Johnson is the third approved to fight the ongoing COVID-19 pandemic in the United States  ... 

Johnson & Johnson's COVID-19 vaccine has been approved for emergency use in the United States.

On Sunday, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to recommend the Johnson & Johnson vaccine to adults 18 years and older in the U.S., according to the Washington Post.

And on Saturday, the Food and Drug Administration (FDA) authorized the vaccine ... "

Read the full article:  CDC Recommends One-Shot Johnson & Johnson COVID-19 Vaccine After FDA Authorizes Emergency Use - People

Food and its packaging are highly unlikely to transmit Covid, top U.S. food and health officials say - CNBC

• FDA CGMP Online Training - respected GMP online training classes conducted by SkillsPlus International Inc. 

According to the article:

• U.S. and international health experts again conclude that there is no evidence of transmission of the coronavirus via food or food packaging.
• Some scientific studies have identified Covid-19 particles on food packaging.
• Most of that research is finding the genetic fingerprint of the virus, not live virus that can result in human infection.

Read the full source article: 
Food and its packaging are highly unlikely to transmit Covid, top U.S. food and health officials say - CNBC

FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA. gov

• FDA GMP QSR cGMP Online Training. Respected GMP online training courses - provided by SkillsPlus International Inc.

According to the news release:

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts

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. for use in individuals 18 years of age and older."

Read the full news release:  FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine - FDA. gov

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

----

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA Authorizes First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - FDA. gov

• GMP Online Training Courses.  FDA GMP QSR cGMP Training - popular online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training

According to the news release:

"Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. 

“Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes,” said FDA Commissioner Stephen M. Hahn, M.D. “As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.” "

Read the full news release:

Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 - Test is authorized for individuals two years of age or older, including those not showing symptoms - FDA.gov

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine - FDA .gov

• FDA cGMP QSR GMP Training. Highly regarded online training classes taught by SkillsPlus International Inc. 

According to the news release:

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts

"The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide."

Read the full news release: FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine -  FDA.gov

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

------

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

What to Know About At-Home Oxygen Therapy - FDA . gov

• FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.
• California HMDR Exemptee Online Training Certification Course

Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy

Giving yourself too much or too little oxygen can be dangerous. Talk with your doctor & get a prescription before buying an oxygen concentrator for use at home.

Read the full source article:  Pulse Oximeters and Oxygen Concentrators: What to Know About At-Home Oxygen Therapy - FDA.gov

According to the article:

"One way to get extra oxygen into the body is by using an oxygen concentrator. Oxygen concentrators are medical devices required to be sold and used only with a prescription.

You should not to use an oxygen concentrator at home unless it has been prescribed by a health care provider. Giving yourself oxygen without talking to a doctor first may do more harm than good. You may end up taking too much or too little oxygen. Deciding to use an oxygen concentrator without a prescription can lead to serious health problems such as oxygen toxicity caused by receiving too much oxygen. It can also lead to a delay in receiving treatment for serious conditions like COVID-19.

Even though oxygen makes up about 21 percent of the air around us, breathing high concentrations of oxygen may damage your lungs. On the other hand, not getting enough oxygen into the blood, a condition called hypoxia, could damage the heart, brain, and other organs.

Find out if you really need oxygen therapy by checking with your health care provider. If you do, your health care provider can determine how much oxygen you should take and for how long."

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

FDA and OSHA Team Up to Publish Checklist to Assist Food Industry During COVID-19 | FDA .gov

• FDA cGMP QSR GMP Training Courses - online classes by SkillsPlus International Inc. 

According to the update:

"To assist the food industry as it navigates changes to operations related to COVID-19, the FDA has teamed up with OSHA to develop the “Employee Health and Food Safety Checklist for Human and Animal Food Operations During the COVID-19 Pandemic.” The checklist pulls from existing guidance provided by the FDA, CDC, and OSHA and serves as a quick reference to help the food industry assess employee health, social distancing, and food safety within workplaces as operations may be impacted by COVID-19. 

The checklist is broken into two distinct sections. The first section focuses on employee health, screening, and operation configuration for social distancing to prevent or minimize the spread of COVID-19 based on guidelines provided by CDC and OSHA. The second section highlights food safety requirements, found in existing regulations, that can help the food industry assess the potential impact of COVID-19-related operational changes on food safety practices. Some operational changes that could impact food safety include closures, changes among food safety staff, or changes to suppliers or ingredients."

Read the full source article: 
FDA and OSHA Team Up to Publish Checklist to Assist Food Industry During COVID-19 | FDA .gov

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

--------

FDA cGMP QSR GMP Training Courses - online classes by SkillsPlus International Inc. 

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store 

COVID-19 - How To Protect Yourself And Others - CDC.gov

The pandemic is not over yet!

The CDC tells us:

How to Protect Yourself & Others

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
Designated Rep Certification Class
CA Designated Representative Training Program
California Designated Representative Training Program
California HMDR Exemptee Training
Exemptee Certification Class
FL CDR Exam Prep
SkillsPlus Intl Inc. - The Leader in Compliance Training
The Health, Drug, Prescription, and GMP Supersite Gift Store