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Theqmnweeklybulletin

Sept. 7, 2012

Vol. 4 No. 36

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ICH Guidance Advocates Use of Risk Assessments for CtQAs

Drugmakers should use risk assessments to identify material attributes and manufacturing process parameters that may affect a drug’s critical quality attributes (CtQAs), an International Conference on Harmonisation (ICH) draft guidance states. Read More

Medtronic Neuro Gets Warning Letter, FDA Wants to Meet on Motor Flaws

Medtronic’s neuromodulation unit has received an FDA warning letter on allegations the business segment did not handle complaints properly, among other corrective and preventive action (CAPA) violations. Read More

EMA to Wait for More Experience Before Issuing Guidance on Companion Diagnostics

Known for its relatively relaxed regulations on companion diagnostics (CDx), guidance from the European Medicines Agency is not expected until there is more experience with these drug-device products, an expert says. Read More

Smartphone Medical Apps Present Opportunity and Challenge: Expert

Mobile medical apps that run on such consumer devices as smartphones and tablets represent a rapidly growing and lucrative device market for innovative companies that do their homework before diving in, an expert in the field says. Read More

Sun Recalls Nimodipine Capsules on Crystallization Concerns

Sun Pharmaceutical is recalling one lot of its 30-mg nimodipine after a customer complaint about possible crystallization of the solution inside the capsule. Read More

Devices Flowing Again After Twin Government Strikes in Brazil End

Brazil’s Anvisa should be operating again at full capacity by mid-September, following government strikes that crippled the agency this summer and left devicemakers unable to obtain registration licenses or get their products in and out of the country. Read More

Apotheca Cited for cGMP Violations in FDA Warning

FDA inspections of Apotheca have revealed possible metal shaving contamination and broken, leaking or damaged bottles for various drugs, resulting in a warning letter. Read More

Chinese Thermometer Plant Warned After ‘Losing’ Design Documents

Ningbo Huahui Medical Instruments was handed an FDA warning letter after telling investigators it lost its design documents for a digital thermometer last year. Read More