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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
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Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.

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FDA Medical Device Compliance and Enforcement: Lessons from Last Year and Your Game Plan…

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Medical Device Complaint Management: Escape the Labyrinth

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FDA’s 2019 Medical Device Regulation Agenda: Are You Prepared

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REMS Regulatory Developments and Best Practices

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Conducting Advanced Root Cause Analysis and CAPA Investigations

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ICH GCP E6 R2: Meeting CRO-Vendor Oversight Requirements

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FDA Clears Soft Tissue Visualization Addon for MRIdian SmartVision

The updated system offers improved imaging for more precise targeting of tumors.
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Compounder to Pay $775,000 Over Kickback Allegations

The payment will resolve a whistleblower lawsuit over unwanted compounded medications from the pharmacy that were billed to Medicare.

CHINESE JVS COULD EASE AMINO ACID PRICE PRESSURE

KEYWORDS Daily International Pharma Alert
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European amino acid manufacturers feeling the pinch from cheaper Chinese imports should consider entering into joint ventures in Asia, advises Frost and Sullivan, since manufacturing costs are lower but quality is still high.

LabTechnologist.com (http://www.labtechnologist.com/news/ng.asp?n=68018-frost-and-sullivan-amino-acids-china)