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

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13th Annual FDA Inspections Summit

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

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

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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.

FDA ANNOUNCES BLACK BOX WARNING ADDITIONS FOR APTIVUS

KEYWORDS Daily International Pharma Alert
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German drugmaker Boehringer Ingelheim and the FDA have announced updates to the black box warning for Aptivus, a treatment for HIV, after it was linked to multiple fatal cases of brain hemorrhaging.

A recent letter to healthcare providers, distributed through the FDA's MedWatch program, said that Aptivus (tipranavir) was linked to 14 events of intracranial hemorrhaging (ICH), including eight fatalities, out of 6,840 HIV-1 infected individuals taking the drug.

The black box warning urges doctors to be cautious in prescribing Aptivus, which is co-administered with Abbot's Norvir, particularly for patients with chronic hepatitis B or hepatitis C co-infections.

Many of the patients experiencing ICH suffered from other medical conditions or were taking other drugs that may have caused or contributed to these events, the letter said. In higher doses and in extreme cases, Aptivus treatment led to bleeding in multiple organs and death.