Webinar: The latest with the FDA user fee reauthorization: Where do we go from here?
August 16, 2022 | 1:00 PM ET
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In Warning Letter to Amazon, FDA makes a case for closer oversight of third-party sellers
A new Warning Letter issued August 10 to Amazon CEO Andy Jassy makes the case that it’s the company’s problem – and not just its third-party sellers – that regulators are able to find unapproved drugs for sale on the company’s website, even though the company itself isn’t making the products. It’s not the first time Amazon has attracted the FDA’s scrutiny, although it could be a harbinger of additional regulatory actions to come.
The new drug pricing legislation: What regulatory professionals need to know
The Senate-passed Inflation Reduction Act (IRA) includes several drug pricing policies that are intended to reduce costs for the Medicare program and its beneficiaries. While most of the policy outlines the reimbursement policy, AgencyIQ took a look at how specific provisions within the legislation might affect regulatory filing strategies by companies.
ECHA finds risk management action for acyl glycinates and sarcosinates not necessary
Last week the European Chemicals Agency (ECHA) published a regulatory needs assessment for acyl glycinates and sarcosinates, concluding that the substance group, whose members are commonly used as surfactants and lubricating and cleaning agents in cosmetics, and washing and cleaning products, among others, does not warrant initiating regulatory risk management measures at the EU level given currently available information.
EPA reaches out to communities exposed to ethylene oxide emissions from commercial sterilizers
The EPA made an announcement on August 3 of its plans to address the risks posed by ethylene oxide (EtO) emissions from commercial sterilizers and to engage with the communities most affected by these emissions due to their proximity to the facilities. EPA will hold a webinar on August 10, to provide current information on risks and plans to reduce exposure followed by meetings in affected communities. EPA also announced a proposed air pollution regulation addressing EtO emissions from commercial sterilizers will be issued later this year.
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