Stephen Hahn Should Focus On Stability In First Days As US FDA Commissioner, Stakeholders Say
Among Hahn's primary duties should be to reassure staff that he will not be making radical changes and begin working on a priority list, experts told the Pink Sheet.
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Show Us The Birth Certificate? An Authorless US FDA Import Policy
For two decades it has been almost dogma in the US pharmaceutical industry that no FDA commissioner would sign off on a policy to permit wholesale imports of drugs from Canada. Now that a proposed rule has been issued – it still may be true.
ANDA Approval Records Will End As US FDA Mops Up Backlog
CDER Director Woodcock says generic approvals remain inflated by applications that languished before FDA’s user fee program began, but as sponsors work through their own backlog of FDA responses, the number of ANDAs cleared by the agency appears likely to fall.
Playing It Safe? Hahn's Biosimilar View
US FDA Commissioner nominee gave a general, scripted answer to a question about biologic patents, but did Stephen Hahn inadvertently go against the agency's stance on the issue?