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FDA warns 10 companies for selling unlawful dietary supplements that claim to treat mental health problems

Today, the U.S. Food and Drug Administration announced warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

19 Feb 2021

USDA, FDA highlight no credible evidence of COVID-19 transmission through food or food packaging

After more than a year since the coronavirus disease 2019 (COVID-19) outbreak was declared a global health emergency, the U.S. Department of Agriculture, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention continue to underscore that there is no credible evidence of food or food packaging associated with or as a likely source of viral transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus causing COVID-19.

18 Feb 2021

Using complementary disinfection strategies to make swimming pools safer

Swimming in indoor or outdoor pools is a healthy form of exercise and recreation for many people. However, studies have linked compounds that arise from chlorine disinfection of the pools to respiratory problems, including asthma, in avid swimmers.

17 Feb 2021

FDA approves novel 3D-printed talus implant for humanitarian use

Today, the U.S. Food and Drug Administration approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use.

17 Feb 2021

FDA approves drug to reduce frequency of chemotherapy-induced bone marrow suppression

Today, the U.S. Food and Drug Administration approved Cosela (trilaciclib) as the first therapy in its class to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage (when the cancer has spread beyond the lungs) small cell lung cancer.

13 Feb 2021

FDA issues EUA for bamlanivimab and etesevimab for COVID-19 treatment

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19.

10 Feb 2021

Study sheds light on dangerous nanomaterials lurking in our consumer products

Our consumer products, such as food, cosmetics and clothes, might be filled with nanomaterials - unbeknownst to us.

9 Feb 2021

Commentary on severe allergic reaction to mRNA SARS-CoV-2 vaccines

A commentary by John M. Kelso, Division of Allergy, Asthma and Immunology, Scripps Clinic, published in the latest issue of the journal Vaccines, discusses anaphylactic reactions to these novel mRNA SARS-CoV-2/COVID-19 vaccines.

8 Feb 2021

FDA permits marketing of new prescription only device to reduce snoring and mild sleep apnea

Today, the U.S. Food and Drug Administration authorized marketing of a new prescription only device intended to reduce snoring and mild obstructive sleep apnea.

5 Feb 2021

$FDA approves cell-based gene therapy to treat adults with relapsed or refractory large-B-cell lymphoma$

FDA approves cell-based gene therapy to treat adults with relapsed or refractory large-B-cell lymphoma

Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment.

5 Feb 2021

FDA schedules meeting to discuss EUA request for Janssen’s COVID-19 vaccine

The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Feb. 26, 2021, to discuss the request for emergency use authorization (EUA) for a COVID-19 vaccine from Janssen Biotech Inc.

5 Feb 2021

FDA continues to support the development of medical products to tackle new virus variants

As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic.

5 Feb 2021

Inhaling unfragmented hyaluronan improves lung function in COPD patients

Researchers at the National Institutes of Health and their collaborators found that inhaling unfragmented hyaluronan improves lung function in patients suffering from severe exacerbation of chronic obstructive pulmonary disease (COPD).

1 Feb 2021

FDA takes action on alcohol-based hand sanitizers from Mexico

As part of the U.S. Food and Drug Administration's continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products' safety.

26 Jan 2021

FDA approves first injectable, complete regimen for HIV-1 infection in adults

The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

21 Jan 2021

E-cigarettes stress and inflame the lungs, impair key regulatory proteins

E-cigarettes stress and inflame the lungs of rats, compromising important regulatory proteins through exposure, according to research recently published in the journal Redox Biology.

18 Jan 2021

FDA issues warning letters to firms selling e-liquids which lack premarket authorization

Today, the U.S. Food and Drug Administration issued warning letters to 10 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, advising them that selling these products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S.

17 Jan 2021

CBP, FDA seize counterfeit, flavored e-cigarettes valued at over $719K

U.S. Customs and Border Protection officers at the Dallas Fort Worth International Airport working in conjunction with agents from the U.S. Food and Drug Administration announced today that they have seized 33,681 units of e-cigarettes with a Manufacturer's Suggested Retail Price of $719,453.

13 Jan 2021

Study shows faster uptake of chemicals in people with a genetically weakened skin barrier

The ability of our skin to protect us from chemicals is something we inherit. Some people are less well-protected which could imply an increased risk of being afflicted by skin disease or cancer.

13 Jan 2021

FDA's AI/ML-Based Software as a Medical Device Action Plan released

Today, the U.S. Food and Drug Administration released the agency's first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency's oversight of AI/ML-based medical software.

12 Jan 2021

Cosmetics News and Research

FDA warns 10 companies for selling unlawful dietary supplements that claim to treat mental health problems

USDA, FDA highlight no credible evidence of COVID-19 transmission through food or food packaging

Using complementary disinfection strategies to make swimming pools safer

FDA approves novel 3D-printed talus implant for humanitarian use

FDA approves drug to reduce frequency of chemotherapy-induced bone marrow suppression

FDA issues EUA for bamlanivimab and etesevimab for COVID-19 treatment

Study sheds light on dangerous nanomaterials lurking in our consumer products

Commentary on severe allergic reaction to mRNA SARS-CoV-2 vaccines

FDA permits marketing of new prescription only device to reduce snoring and mild sleep apnea

FDA approves cell-based gene therapy to treat adults with relapsed or refractory large-B-cell lymphoma

FDA schedules meeting to discuss EUA request for Janssen’s COVID-19 vaccine

FDA continues to support the development of medical products to tackle new virus variants

Inhaling unfragmented hyaluronan improves lung function in COPD patients

FDA takes action on alcohol-based hand sanitizers from Mexico

FDA approves first injectable, complete regimen for HIV-1 infection in adults

E-cigarettes stress and inflame the lungs, impair key regulatory proteins

FDA issues warning letters to firms selling e-liquids which lack premarket authorization

CBP, FDA seize counterfeit, flavored e-cigarettes valued at over $719K

Study shows faster uptake of chemicals in people with a genetically weakened skin barrier

FDA's AI/ML-Based Software as a Medical Device Action Plan released

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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