EPA Issues Final SNURs for 145 Chemical Substances

August 21, 2019

The U.S. Environmental Protection Agency (EPA) published in the Federal Register final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 145 chemical substances that are the subject of premanufacture notices (PMN).  84 Fed. Reg. 43266.  According to EPA, the chemical substances are subject to orders issued by EPA pursuant to TSCA Section 5(e).  The final SNURs require persons who intend to manufacture (defined by statute to include import) or process any of the 145 chemical substances for an activity that is designated as a significant new use by the rule to notify EPA at least 90 days before commencing that activity.  The required notification initiates EPA’s evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period.

Spotlight

Corbus Pharmaceuticals

Corbus Pharmaceuticals Holdings, Inc. is a Phase 3 clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. The Company's lead product candidate, anabasum, is a novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and fibrotic processes. Anabasum has demonstrated positive clinical data in Phase 2 studies evaluating anabasum for the treatment of diffuse cutaneous systemic sclerosis and for the treatment of cystic fibrosis. Additionally, anabasum is being evaluated in a Phase 2, 12-month open-label extension study in systemic sclerosis, a Phase 2 study in skin-predominant dermatomyositis with a 12-month open-label extension, and another Phase 2 study in systemic lupus erythematosus is scheduled to commence in H2 2017.

OTHER ARTICLES

Transporting biological and chemical materials - what you need to know

Article | February 13, 2020

The landscape of biological and chemical logistics has changed rapidly - as have the regulatory frameworks around it. What has not necessarily kept pace is the end-user understanding of the nature of these logistical processes, their opportunities and their constraints. Twenty years ago, the transmission of biological and chemical materials was limited to a small range of organisations: usually national and international research companies, hospitals, major university departments, police and military departments with forensic responsibilities.

Read More

Setting record straight on testing harm in chemicals

Article | February 13, 2020

The modern world is built on chemicals, be it the medicines we use, or cleaning fluids, crop protection products, or the raw materials for everything from laptops and mobile phones to clothes and furniture. Across all, we have created an entire modern society with chemicals, and, as a result, constantly stretched the size of the world population we can feed, clothe and shelter. Yet, balancing all the gains from the modern chemistry around us against any negative environmental and human impact has been a rising concern, making for ever greater focus on testing and on risk assessment.

Read More

Why chemical characterization is the best way to assess patient risk

Article | February 11, 2020

Everyone is very familiar with the phrase when buying a house: All that really matters are three things - location, location, and location. This same principle applies to extractables and leachables chemistry analysis – the three things that truly matter are identification, identification, and identification. The greatest growth in the past ten years in demonstrating the safety of medical devices and container closure systems for drugs has been using analytical chemistry to determine what chemicals can leach from the device and what the patient is exposed to during its intended use.

Read More

How Chemical Companies Benefit from the Experience Economy

Article | February 10, 2020

To feel or experience from a business engagement started with customer experience mainly in the consumer products business. Today it has extended to even knowledge industries like the chemical industry where experiencing or feeling can be leveraged to include all stake holders from customers primarily to employees to supply chain people & suppliers and all else. With digital technologies this has become easier than before. The benefits from promoting the ‘feel’ or ‘experience’ emotion could be multifarious for the chemical industry as described in this article.

Read More

Spotlight

Corbus Pharmaceuticals

Corbus Pharmaceuticals Holdings, Inc. is a Phase 3 clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. The Company's lead product candidate, anabasum, is a novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and fibrotic processes. Anabasum has demonstrated positive clinical data in Phase 2 studies evaluating anabasum for the treatment of diffuse cutaneous systemic sclerosis and for the treatment of cystic fibrosis. Additionally, anabasum is being evaluated in a Phase 2, 12-month open-label extension study in systemic sclerosis, a Phase 2 study in skin-predominant dermatomyositis with a 12-month open-label extension, and another Phase 2 study in systemic lupus erythematosus is scheduled to commence in H2 2017.

Events