With a potential US government shutdown looming, Megha Sinha, Kamet Consulting, says to treat FDA disruptions as predictable risks by protecting milestones and early readiness.
The U.S. Food and Drug Administration (FDA) has issued a draft guidance reminding the cosmetics industry that the agency can access a variety ...
In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often ...
The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...
The FDA is ramping up oversight of foreign manufacturing sites by expanding its use of unannounced inspections, a move aimed at leveling the playing field between domestic and international drugmakers ...
On June 2, 2025, the U.S. Food and Drug Administration (FDA) announced the deployment of its own artificial intelligence system, “Elsa.” The large language model-powered system was scheduled for ...
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