Is Silence Golden For Brand Companies On Inspection Fees?
The inspection and establishment fee issue likely will remain a prickly subject for brand companies in the coming years, especially if a program is successfully launched for generics.
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Inspection Fees Face Tough Road In Congress As PhRMA Remains Opposed
At user fee hearing, PhRMA’s Wheadon counters questions from Rep. Dingell, saying FDA already is receiving resources to conduct GMP inspections outside the U.S.
U.S. FDA Envisions Many Regulatory Coalitions Dealing With Globalization Issues
U.S. FDA could help create several international coalitions to carry out its new globalization plan, which could allow for issue-specific groups focused on individual pharmaceutical sectors