Upcoming webinars: 2023 FDA Forecast and 2023 EMA/EU Device Forecast
Tuesday, December 6, and Wednesday December 7, at 12:00pm ET.
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Our team of nonpartisan experts, along with customizable, intelligent, analysis solutions clear a path through complex regulation, helping you accelerate action in your industry and improve business-critical outcomes.
Access AgencyIQ’s Commitment Letter Tracker
The FDA is preparing to make hundreds of changes as part of its commitments under the upcoming PDUFA, MDUFA, GDUFA and BsUFA reauthorizations. AgencyIQ’s new resource will help you keep track of what commitments are upcoming and when to expect them.
In anticipation of potential naloxone Rx to OTC switch, FDA requests info on regulatory, scientific issues
Naloxone – an emergency opioid overdose reversal measure – is a good candidate for over-the-counter (OTC) designation. However, such an Rx to OTC switch raises some regulatory questions.
EPA publishes final revision to Risk Determination for methylene chloride
The EPA announced the final revision to the Risk Determination for methylene chloride as a whole chemical substance under the Toxic Substances Control Act (TSCA). This revised Risk Determination concludes that methylene chloride presents an unreasonable risk of injury to health and supersedes the previous condition of use-specific no unreasonable risk determinations in the 2020 methylene chloride Risk Evaluation.
Industry weighs in on proposal to restrict dipolar aprotic solvents DMAC and NEP
So far, companies have delivered mixed comments to ECHA on the REACH Annex XVII restriction on DMAC and NEP proposed by the Netherlands. As the ECHA committees prepare their opinions on the Dutch proposal, industry still has a little over a month to make their concerns known in the ongoing consultation on restricting the two dipolar aprotic solvents.
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From biotechnology to agriculture, dietary supplements to nanomaterials, and legal and consulting regulations, AgencyIQ makes navigating through complex rules simple. Sources are tailored to your industry’s world, so you can stay plugged in to the regulatory landscape and clearly map out organizational success. Learn more about our regulatory intelligence solution below.
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