Cosmetics News and Research

RSS

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

FDA conditionally approves first oral treatment for dogs with lymphoma

Today, the U.S. Food and Drug Administration conditionally approved Laverdia-CA1 (verdinexor tablets) to treat dogs with lymphoma, a type of cancer of the lymph nodes and lymphatic system.

11 Jan 2021

FDA alerts health care providers and clinical laboratory staff about SARS-CoV-2 viral mutation

The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus's genome assessed by that test.

8 Jan 2021

FDA takes first steps in bringing clarity to emerging area of individualized drug development

Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases.

4 Jan 2021

FDA approves first generic glucagon for injection to treat severe hypoglycemia

Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus.

28 Dec 2020

FDA takes further steps to strengthen REMS program to confront opioid crisis

While our efforts to combat COVID-19 remain at the forefront of our day-to-day activities, the U.S. Food and Drug Administration also continues its work on a number of important public health issues and, in particular, the opioid crisis.

23 Dec 2020

FDA authorizes first device to treat patients with walled-off pancreatic necrosis

Today, the U.S. Food and Drug Administration authorized marketing of the EndoRotor System to resect (cut out) and remove necrotic (dead) tissue for patients with walled-off pancreatic necrosis (WOPN), a potentially deadly condition which can occur several weeks after an episode of severe acute pancreatitis, often requiring tissue removal.

23 Dec 2020

FDA issues warning letters to companies illegally selling unapproved CBD products

Today, the U.S. Food and Drug Administration issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

22 Dec 2020

FDA issues first emergency use authorization for second COVID-19 vaccine

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).

21 Dec 2020

FDA approves first adjuvant treatment for patients with non-small cell lung cancer

Today, the U.S. Food and Drug Administration approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.

18 Dec 2020

FDA approves first implant system for adults who have above-the-knee amputations

The U.S. Food and Drug Administration today approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant system marketed in the U.S. for adults who have transfemoral—or above-the-knee—amputations and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis.

18 Dec 2020

FDA approves first oral drug for treating adult patients with advanced prostate cancer

Today, the U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer.

18 Dec 2020

Certain male enhancement and weight loss products may pose serious health risk, warns FDA

The U.S. Food and Drug Administration is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk.

18 Dec 2020

FDA issues new emergency use authorization for BinaxNOW COVID-19 Ag Card Home Test

Today, the U.S. Food and Drug Administration issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription.

16 Dec 2020

FDA grants marketing authorization for new ACL implant

Today, the U.S. Food and Drug Administration granted marketing authorization—under the De Novo premarket review pathway—for an anterior cruciate ligament (ACL) implant, intended to serve as an alternative to ACL reconstruction to treat ACL tears.

16 Dec 2020

FDA issues emergency use authorization for first fully at-home OTC COVID-19 diagnostic test

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.

15 Dec 2020

Hazardous chemicals in plastics threaten human health

Plastics contain and leach hazardous chemicals, including endocrine-disrupting chemicals (EDCs) that threaten human health.

15 Dec 2020

Study: Silica offers the best environmental alternative to plastic microbeads

Following bans on plastic microbeads in wash-off cosmetics, a new study weighs up the environmental costs of alternatives. Microbeads have been included in personal care and cosmetic products ranging from toothpaste and sunscreen to body scrubs and industrial hand cleaners, usually to improve qualities like abrasiveness.

15 Dec 2020

FDA approves first IGA in GalSafe pigs for human food, promising therapeutic uses

Today, the U.S. Food and Drug Administration approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics.

15 Dec 2020

FDA approves first COVID-19 direct-to-consumer test

Today, the U.S. Food and Drug Administration authorized LabCorp's Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription.

9 Dec 2020

Cosmetics News and Research

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

FDA conditionally approves first oral treatment for dogs with lymphoma

FDA alerts health care providers and clinical laboratory staff about SARS-CoV-2 viral mutation

FDA takes first steps in bringing clarity to emerging area of individualized drug development

FDA approves first generic glucagon for injection to treat severe hypoglycemia

FDA takes further steps to strengthen REMS program to confront opioid crisis

FDA authorizes first device to treat patients with walled-off pancreatic necrosis

FDA issues warning letters to companies illegally selling unapproved CBD products

FDA issues first emergency use authorization for second COVID-19 vaccine

FDA approves first adjuvant treatment for patients with non-small cell lung cancer

FDA approves first implant system for adults who have above-the-knee amputations

FDA approves first oral drug for treating adult patients with advanced prostate cancer

Certain male enhancement and weight loss products may pose serious health risk, warns FDA

FDA issues new emergency use authorization for BinaxNOW COVID-19 Ag Card Home Test

FDA grants marketing authorization for new ACL implant

FDA issues emergency use authorization for first fully at-home OTC COVID-19 diagnostic test

Hazardous chemicals in plastics threaten human health

Study: Silica offers the best environmental alternative to plastic microbeads

FDA approves first IGA in GalSafe pigs for human food, promising therapeutic uses

FDA approves first COVID-19 direct-to-consumer test

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Latest News