A Sign Of Long-Term Improvement Of ANDA Review Process
February 12, 2014, 3:45 PM EST
Law360, New York (February 12, 2014, 3:45 PM EST) -- On Jan. 23, the U.S. Food and Drug Administration announced the establishment of a public docket for comments on improving the completeness and quality of abbreviated new drug application submissions to the agency. Specifically, the FDA is asking how it can reduce the occurrence of common deficiencies in the following aspects: filing, chemistry, sterility, bioequivalence, fatal flaws and drug master files.
The FDA is asking about the difficulties that sponsors experience, and is also seeking input on how to best share its own suggestions to improving...