All posts by Admin

23

Feb'18

USFDA completed its Inspection at Sun Pharma’s Halol Facility with Three Observations

The Company informed in its’s update that the US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharmaceutical …

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06

Feb'18

Types of Patents, Exclusivity and Hatch-waxman Act.

At the time of fling an ANDA application (Generic drug application), an applicant must provide, information related to any patents …

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22

Jan'18

FDA Releases Agenda for New & Revised Guidances for Year 2018

For year 2018, Centre for Drug Evaluation and Research (CDER) of USFDA is Planning to Published New & Revised Draft …

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08

Jan'18

Drug Recalls

 What is a drug recall? Recall is an action taken to withdraw/remove the drugs from distribution or use in the …

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03

Jan'18

FDA 483 and Warning Letter

For the purpose of protecting public health and ensures compliance with the Food, Drug and Cosmetic Act, Food and Drug Administration …

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