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The U.S. Environmental Protection Agency (EPA) announced on August 11, 2025, the results of process improvements to accelerate the review of Low Volume Exemptions (LVE) in the Toxic Substances Control Act (TSCA) New Chemicals...more
What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more
On May 2, 2025, U.S. Environmental Protection Agency (EPA) Administrator Lee Zeldin announced the “[n]ext phase of organizational improvements to better integrate science into agency offices.” As part of this reorganization...more
Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing....more
On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Act), enacting a number of reforms to the Toxic Substances Control Act (TSCA) that are aimed to modernize and...more