Eleven drugmakers led by Pfizer and Novartis have set aside a combined $2 billio...
) are also investing in gene therapy manufacturing, according to a Reuters analysis of public filings and executive interviews.
One of the former executives, Brian Kaspar, denied wrongdoing in a statement to Reuters. Another, his brother Allan Kaspar, could not be reached for comment. According to four of them, the FDA has stressed in recent meetings the need for continuity in production processes all the way from the development of a drug to its commercialization.
“Manufacturing consistency is always a major concern for the agency,” FDA spokeswoman Stephanie Caccomo told Reuters.
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