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USFDA Guidance: Establishing Impurity Specifications for Antibiotics and NIOSH-Approved Air-Purifying Respirators Compliance Policy
The FDA continues to strengthen regulatory expectations across both pharmaceutical quality and medical device oversight, with two important draft guidances issued in April 2026. The guidance Establishing Impurity Specifications for Antibiotics (April 2026, Draft) and Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators (April 20, 2026, Draft) provide structured recommendations for industry and regulators. Guidanc
Sharan Murugan
Apr 203 min read