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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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Oct 18

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

Oct 18

The CDER Reorganization: What It Means for Drugmakers

Oct 23

13th Annual FDA Inspections Summit

Oct 30

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Oct 30

Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

Nov 1

SOPs and Policies for the 21st Century: Why Less is More

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MHRA Recalls Digital Pregnancy Tests

The recall affected one lot involving 58,000 tests distributed in the UK. 
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Miami Pharmacy Owner Admits to Submitting Over $8 Million in Fraudulent Medicare Claims

The plea followed an investigation by the Justice Department’s Medicare Fraud Strike Force.

WHO ADDS RANBAXY ARVS TO PRE-QUALIFICATION LIST

KEYWORDS Daily International Pharma Alert
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The World Health Organization (WHO) has added two of India-based Ranbaxy's antiretroviral (ARV) products to its pre-qualification list. The products approved by the WHO are Efavirenz, in 600 mg tablets and 200mg capsules, and Stavudine, in 30 mg capsules and 40 mg capsules.

With these inclusions, Ranbaxy now has a total of 12 ARVs on the WHO pre-qualification list.

"This is a significant development," said Malvinder Mohan Singh, CEO of Ranbaxy. "Efavirenz is rapidly becoming a preferred drug in HIV treatment program in developing countries, [and] Stavudine, is also being widely used as a first-line therapy against AIDS. Both products increase customer choice enabling patients to access therapy easily."