FDA Looks to Company Executives More to Address Quality Control Issues

November 5, 2010
Recent FDA warnings that it will hold pharma executives accountable for companies’ violations signify “somewhat of a change in philosophy,” for the agency as it works to identify and publicize industry-wide quality issues sooner, an FDA official says. The agency expects clear and open communication from corporate officials, particularly if a problem that could impact public health is identified, CDER Office of Compliance Director Deborah Autor said at FDAnews’ Fifth Annual FDA Inspections Summit. This can help the agency act quickly on problems that could impact other companies.
Drug Industry Daily