to Require Earlier Release of Adverse Trial Data; FDA Plans More Communication on Drug Risks; FDA Sets Out Rules for Distribution of Papers on Unapproved Uses; Grassley Asks GAO to Probe FDA Approvals; Supreme Court Splits on Rezulin Question; Medical Device Amendments Shield Manufacturers; PDUFA...
The short answer to this question is: Wrong. The good guidance practices regulations (21 CFR 10.115), which were revised in April 2017, address whether guidance recommendations are requirements.2Technically, no, they are not. However, the regulations go on to explain that guidanc...
At the same time, with the continuous mutation and spread of the new crown virus strain, people began to question the effectiveness of the COVID-19 vaccine, and there was some resistance to booster doses and the children’s vaccine. Based on the evolution of the public’s emotions, we ...
A common question that new users have is how to create a system with mixed solvent (urea or DMSO at a given concentration in water, for example). The simplest procedure for accomplishing this task is as follows: * Determine the number of co-solvent molecules necessary, given the box dimensi...
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