Simplifying Global Compliance
The FDA is requesting that certain OTC topical antiseptic drugs be repackaged with updated labeling to decrease the risk of infection resulting from their improper use. Read More
Alexion’s recall and replacement of vials of its rare disease drug Soliris could cost the company between $10 and $25 million in the fourth quarter, the drugmaker says in a Tuesday SEC filing. Read More
India plans to extend its postmarket surveillance requirements for drugs from four years to six under a Ministry of Health proposal. Read More
FDA reviewers are recommending approval of Vanda’s sleep drug tasimelteon for the visually impaired, overcoming initial disagreements with the company over acceptable primary endpoints. Read More
Drugmakers should establish a company task force of upper management and quality personnel to prevent drug shortages, according to new good practice guidelines developed by the European Federation of Pharmaceutical Industries and Associations (EFPIA). Read More
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