FDA
The U.S. Food and Drug Administration announced today the approval of Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs.
| 2 min read
The FDA and other regulatory agencies consider the integrity of laboratory data to be an integral part of the drug manufacturing process. Deficiencies of out-of-specification (OOS) investigations continue to be the major cause of warning letters in the pharmaceutical industry.
| 5+ min read
