Webinar: What’s ahead for FDA in Q2 and Q3? | Tuesday, April 4, 2023, 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.
Unpacking FDA’s long-expected Digital Health Technology Framework
As part of the Prescription Drug User Fee program reauthorization, the FDA just published its framework for DHTs. The document provides a roadmap for the development of DHT policies, including the essential questions it must answer and the guidance, policies and activities it plans to undertake.
Congress pushes for new FDA authorities to identify and address drug shortages
A report issued by the Senate Homeland Security and Governmental Affairs Committee Majority highlights the scale and ongoing nature of the drug shortage crisis in the U.S. But FDA watchers should keep an eye on something else: The potential for the report to act as a blueprint for future legislation.
EPA expedites protections on high risk uses of four organophosphates
The EPA has announced updated occupational and non-occupational spray-drift exposure risk assessments for four organophosphate pesticides. In order to mitigate significant risks to human health, EPA has expedited these assessments prior to completing the standard registration review process for diazinon, ethoprop, phosmet, and tribufos.
EU Commission to add dozens of chemicals to PIC Regulation
As part of its annual review of the Prior Informed Consent Regulation’s first annex, the Commission has proposed the inclusion of dozens of new hazardous chemicals. The delegated act implements the Rotterdam Convention as well as relevant EU chemicals legislation to subject new substances to export notification and PIC procedures.
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