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
Australia’s Therapeutic Goods Administration (TGA) is offering drugmakers a more streamlined approach for reporting adverse events in an effort to reduce manual data entry and the possible double handling of information. 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
A bill that will require drugmakers to establish a pedigree system for pharmaceuticals within one year is expected to reach President Obama’s desk this Friday. Read More
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