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SkillsPlus International Inc.

The leader in compliance training

Specializing in:

• FDA cGMP online training programs and courses
• California Designated Representative training courses for license applicants
• California HMDR Exemptee training certification for license applicants

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U.S. Senate narrowly confirms Dr. Robert Califf to lead FDA for second time – Reuters

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

U.S. Senate narrowly confirms Dr. Robert Califf to lead FDA for second time – Reuters

Welcome Back, Commissioner Califf! Robert M. Califf, M.D., was sworn in as the Commissioner of Food and Drugs on February 17, 2022. – FDA.gov

The FDA’s Cigarette Health Warning Rule Is Postponed to April 2023

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U.S. Graphic Health Warnings Postponed Again

According to the article:

Source: FDA.gov

"The U.S. Food and Drug Administration has postponed the effective date of its “Required Warnings for Cigarette Packages and Advertisements” final rule to April 9, 2023, following a Feb. 10, 2022, ruling by the U.S. District Court for the Eastern District of Texas.

The move marks at least the fifth delay for graphic warning health warnings in the United States when counting previously set launch dates of June 18, 2021, Oct. 16, 2021, Jan. 14, 2022, April 14, 2022, and July 13, 2022."

Read the full source article:  U.S. Graphic Health Warnings Postponed Again - Tobacco Reporter

Learn more at: Cigarette Labeling and Health Warning Requirements - FDA.gov

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#FDA #CGMP #GMP

Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe - FDA.gov

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According to the FDA:

"Consumers need to beware of products to lighten or whiten their complexion. These products, which include both injectable skin whitening and skin bleaching products, are potentially unsafe and ineffective, and might contain unknown harmful ingredients or contaminants.

Injectable skin whitening products are marketed for injection into a vein or muscle or under the skin. They are sold online and in some retail outlets and health spas. They often promise to lighten the skin, correct uneven skin tone, and reduce blemishes. Some products even claim to treat conditions such as liver disorders and Parkinson’s disease.

Although the average consumer might not assume so, these products are unapproved new drugs whose sales are not condoned by the U.S. Food and Drug Administration (FDA). The FDA has not approved any injectable drugs for skin whitening or lightening."

Source:  Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe - FDA.gov

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

FDA Warns Companies Illegally Selling Hangover Remedies - FDA.gov

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Read the full news release:  FDA Warns Companies Illegally Selling Hangover Remedies - FDA.gov

According to the article:

... "the U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (doing business as Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC."

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National Women's Health Week - Health Topics on FDA.gov

Mother's Day kicked off National Women's Health Week - May 11-17, 2014.  Follow the links below to information and resources from the FDA.

Women's Health Topics - FDA.gov:

"Take Time to Care about Your Health. Women often spend so much time helping others that they don't take time for themselves. It's OK to take time to focus on good health."

'via Blog this'

More from the FDA:
Watch a video or read a fact sheet to learn helpful tips on health issues like:

• Birth Control
• Breast Implants
• Diabetes
• Heart Health
• Mammograms
• Menopause
• Pregnancy
• Safe Medication Use
• Other Topics like cosmetics, nutrition, and HPV 

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