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March 23, 2018
The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.
March 20, 2018
The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.
The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.
March 16, 2018
The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.
March 15, 2018
The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.
March 13, 2018
Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.
March 02, 2018
This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.
In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.
FDA enforcement efforts and drug approvals trend upward.
Drug companies must consider all factors impacting the cost of drugs, including high costs of early development stages.