FDA Considering Manufacturer Contracting Guidance
Document could provide more detail on the agency’s contractor management expectations, which now are covered in several different documents.
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Public meeting will solicit stakeholder comments on how FDASIA-mandated import regulations should be implemented as the expedited entry program reemerges.
FDA will need a bit of time to develop a comprehensive database of all the facilities that produce active pharmaceutical ingredients and finished dosage forms for the U.S. market as part of the proposed generic drug user fee program.
The effort to prepare for and prevent drug shortages resembles a “he said, she said” argument between FDA, practitioners and industry, where the actual cause of many shortages remains a matter of debate.