Are you sure you'd like to remove this alert? You will no longer receive email updates about this topic.
Biologics center's director encourages sponsors to invite other regulators to early FDA meetings in effort to scale up markets.
FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.
Latest From Manufacturing
Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.
Health ministers have called for more action on access to medicines, including a new EU work agenda, rebuilding Europe’s manufacturing capabilities, further action on pricing, and greater leeway for member states to mitigate drug shortages by restricting parallel exports.
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.
Hiring travails, inspection pre-announcement, lack of translators highlighted in congressional hearing on FDA foreign inspections.
EU regulators say that sponsors must complete their nitrosamine-related risk evaluations for all EU medicines containing chemically-synthesised active substances within the six-month timeframe.
Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.
All set! This article has been sent to email@example.com.
All fields are required. For multiple recipients, separate email addresses with a semicolon.
Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.