Regulatory Affairs

06

Feb'15

FDA warning letters-2015 on Data Integrity Issues

FDA issued two warning letters in January 2015 relating to Data Integrity Data integrity is essential requirement in a pharmaceutical …

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24

Dec'14

Rapivab (Peramivir) got US FDA Approval

On December 19, the U.S. Food and Drug Administration approved Rapivab (Peramivir) to treat influenza infection in adults. Influenza, commonly …

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24

Dec'14

An Over view of Stability Testing of Pharmaceutical Products

Over view of Stability Testing of Pharmaceutical Products What is Stability? Stability of a pharmaceutical product may be defined as …

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