ANDA question-based-review adherence
Executive Summary
More than 90 percent of ANDA submissions include quality overall summaries as of July, FDA reports. The agency requested in January that generic drug applications include a quality overall summary that answers questions related to the ANDA's Chemistry, Manufacturing and Controls section. Over the span of seven months, that number has increased dramatically, showing a positive response to the agency's use of question-based reviews. Although the goals, implemented in 2005 as a pilot program, caused some generic firms to express concern that QbR would extend review periods and provide FDA more opportunity to find fault with applications, initial experiences with the program have not shown such adverse effects (1"The Pink Sheet" Nov. 13, 2006, p. 17)...
You may also be interested in...
Question-Based Review Not Raising Questions For Generic Sponsors, FDA
Initial experiences with question-based reviews of the chemistry, manufacturing and controls section of ANDAs suggest the quality initiative will not adversely affect the generics review process for sponsors
California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits
The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.
Kenvue Breaks Ground On New Headquarters, Appoints Chief Corporate Affairs Officer
Firm hosts groundbreaking for 290,000 square-foot global headquarters it’s having built in Summit, NJ, starting with 100,000 square-foot science and innovation and expected to open in 2025. It announced adding Russell Dyer as chief corporate affairs officer starting 13 March.