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FDA issues warning letters to companies selling dietary supplements containing cesium chloride

The U.S. Food and Drug Administration today posted five warning letters issued to companies marketing dietary supplements containing cesium chloride.

13 Oct 2020

FDA awards six clinical trial research grants to enhance development of therapies for rare diseases

Today, the U.S. Food and Drug Administration announced that it has awarded six new clinical trial research grants to principal investigators from academia and industry totaling over $16 million over the next four years.

8 Oct 2020

FDA reaffirms commitment to protect laboratory safety and security

The U.S. Food and Drug Administration's mission to protect and promote public health by ensuring the safety of the nation's food supply, as well as the safety and efficacy of medical products, has always relied on a rigorous analysis of the scientific data available and a strong commitment to safety.

8 Oct 2020

FDA and Mexican regulatory counterparts strengthen partnership on food safety

Today, during a virtual ceremony, the U.S. Food and Drug Administration and its regulatory counterparts in Mexico - the Federal Commission for the Protection from Sanitary Risks and the National Service of Agro-Alimentary Health, Safety and Quality - enhanced a partnership to work together on food safety in both countries.

5 Oct 2020

FDA releases final guidance to improve patient communication about risks of breast implants

Today, the U.S. Food and Drug Administration issued the final guidance, "Breast Implants - Certain Labeling Recommendations to Improve Patient Communication," as part of the agency's effort to help improve the information available to patients and health care professionals about the risks of breast implants.

28 Sep 2020

Ascorbic acid: A versatile catalyst for the synthesis of organic compounds

One of the important objectives of green chemistry is the use of eco-friendly solvents and catalysts to perform chemical reactions.

26 Sep 2020

FDA approves first drug for patients with hypereosinophilic syndrome in nearly 14 years

Today, the U.S. Food and Drug Administration approved Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome (HES) for six months or longer without another identifiable non-blood related cause of the disease.

25 Sep 2020

FDA issues updated recommendations concerning dental amalgam

Part of our role in protecting patients is to regularly evaluate, monitor and update scientific evidence on the risks from medical devices—including issues related to the materials used in devices, such as metals.

25 Sep 2020

FDA takes actions to help provide safe, more affordable drugs to Americans

Today, the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration took actions to help provide safe, effective, and more affordable drugs to American patients as part of the Safe Importation Action Plan, fulfilling the aspect of the July Executive Order on drug pricing to complete the rulemaking to allow states to import certain prescription drugs from Canada.

24 Sep 2020

FDA finalizes molluscan shellfish equivalence determination for two EU Member States

Today, the U.S. Food and Drug Administration finalized a molluscan shellfish equivalence determination for two European Union (EU) Member States, Spain and the Netherlands.

24 Sep 2020

FDA issues emergency use authorization for first serology point-of-care test for COVID-19

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19.

24 Sep 2020

FDA announces requirement of class-wide labeling changes for benzodiazepines

The U.S. Food and Drug Administration announced today in a Drug Safety Communication that it is requiring an update to the Boxed Warning, the agency's most prominent safety warning, and requiring class-wide labeling changes for benzodiazepines to include the risks of abuse, misuse, addiction, physical dependence and withdrawal reactions to help improve their safe use.

23 Sep 2020

FDA proposes updates to clarify evidence related to 'intended use' of FDA-regulated products

Today, we proposed updates to our regulations to clarify the types of evidence the FDA considers when determining the "intended use" of a product.

22 Sep 2020

FDA establishes the Digital Health Center of Excellence

Today, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH).

22 Sep 2020

New comparative performance data published for authorized COVID-19 molecular diagnostic tests

Today, the U.S. Food and Drug Administration published comparative performance data for some authorized COVID-19 molecular diagnostic tests.

16 Sep 2020

FDA takes action against Illinois-based food manufacturer for repeated food safety violations

The U.S. Food and Drug Administration announced today that Fortune Food Product, Inc., an Illinois-based processor of sprouts and soy products, has agreed to stop production until it, among other things, undertakes remedial action and complies with the Federal Food, Drug, and Cosmetic Act.

15 Sep 2020

FDA issues warning letters to website operators for illegally selling opioids online

The U.S. Food and Drug Administration has issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids online in violation of the Federal Food, Drug, and Cosmetic Act.

10 Sep 2020

New data reveals overall decline in e-cigarette use, alarming uptick in use of disposable products by youth

Today, the U.S. Food and Drug Administration, in partnership with the Centers for Disease Control and Prevention, released new data from the 2020 National Youth Tobacco Survey, which show 1.8 million fewer U.S. youth are currently using e-cigarettes compared to 2019.

9 Sep 2020

FDA publishes guidance on control of nitrosamine impurities in drugs

Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Drug Administration has undertaken a thorough investigation in an effort to protect patients.

1 Sep 2020

FDA approves a hybrid closed loop diabetes management device for young pediatric patients

Today, the U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their caregivers for use by individuals aged 2 to 6 with type 1 diabetes.

31 Aug 2020

Cosmetics News and Research

FDA issues warning letters to companies selling dietary supplements containing cesium chloride

FDA awards six clinical trial research grants to enhance development of therapies for rare diseases

FDA reaffirms commitment to protect laboratory safety and security

FDA and Mexican regulatory counterparts strengthen partnership on food safety

FDA releases final guidance to improve patient communication about risks of breast implants

Ascorbic acid: A versatile catalyst for the synthesis of organic compounds

FDA approves first drug for patients with hypereosinophilic syndrome in nearly 14 years

FDA issues updated recommendations concerning dental amalgam

FDA takes actions to help provide safe, more affordable drugs to Americans

FDA finalizes molluscan shellfish equivalence determination for two EU Member States

FDA issues emergency use authorization for first serology point-of-care test for COVID-19

FDA announces requirement of class-wide labeling changes for benzodiazepines

FDA proposes updates to clarify evidence related to 'intended use' of FDA-regulated products

FDA establishes the Digital Health Center of Excellence

New comparative performance data published for authorized COVID-19 molecular diagnostic tests

FDA takes action against Illinois-based food manufacturer for repeated food safety violations

FDA issues warning letters to website operators for illegally selling opioids online

New data reveals overall decline in e-cigarette use, alarming uptick in use of disposable products by youth

FDA publishes guidance on control of nitrosamine impurities in drugs

FDA approves a hybrid closed loop diabetes management device for young pediatric patients

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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