We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as ...
The attributes of the DS or DP that are to be tested to obtain the necessary information about product quality safety and efficacy are determined during the Drug Development stage. The information ...
Method-transfer kits help simplify analytical method transfer for global site certifications. Method transfers are required to enable critical medications to reach ...
Method-transfer kits help simplify analytical method transfer for global site certifications. Method transfers are required to enable critical medications to reach ...
The data generated using analytical test methods is essential for many of the critical decisions made in the pharmaceutical industry. To be confident in the integrity of this data it is crucial that ...
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