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Manufacturing

Set Alert for Manufacturing

US FDA's Marks: Gene Therapy Success Could Hinge On Regulatory Convergence

Biologics center's director encourages sponsors to invite other regulators to early FDA meetings in effort to scale up markets.

Regenerative Medicine Manufacturing Quality

Generic Industry Not Sold On Benefits Of FDA Emerging Technology Program

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.

Manufacturing Quality BioPharmaceutical

Latest From Manufacturing

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.


Manufacturing Quality

EU Ministers Want Decisive Action On Medicines Access & Shortages

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.

Europe Distribution

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.

Manufacturing Quality

US FDA Could Use More Foreign Investigators If It Could Find Them, Woodcock Says

Hiring travails, inspection pre-announcement, lack of translators highlighted in congressional hearing on FDA foreign inspections.

Enforcement Manufacturing

Sticking To Nitrosamine Evaluations Deadline Is Priority For EU Regulators

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.

Europe Manufacturing

Global Scare Over Nitrosamine Impurities Extends To Diabetes Medication

Singapore recalls trigger international reaction as metformin is added to growing list of chronic medications found to contain NDMA.

Manufacturing Quality
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