Joanne S. Eglovitch
Senior Editor
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Latest From Joanne S. Eglovitch
FDA Slams Teligent For Lax Approach To Complaint Handling And Stability Testing
Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.
The FDA Builds On Lessons Learned In Rebuilding Quality Metrics Program
US FDA officials tell industry that implementing a quality metrics program is an agency priority and that a rejiggered program will incorporate various elements of other quality metrics initiatives being piloted by the agency, industry and academia.
Data Integrity Remains Challenging For API Manufacturers
Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.
US FDA Mulls Pilot To Examine Separate Review Pathway For Novel Excipients
Proposal could yield a bounty of new options for innovative drug delivery systems.
US FDA Says Data Integrity Remains Challenging For API Manufacturers
Data integrity issues were raised in many warning letters to active pharmaceutical ingredient manufacturers over the past four years.
US FDA Suggests Using ICH Drug Guidance To Meet Device Quality Requirements for Transdermals
FDA’s draft guidance on transdermal and topical delivery systems says manufacturers can leverage pharmaceutical development studies principles for device design control requirements.