Drug Industry Daily

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The FDA has notified Chelsea Therapeutics that its proposal for using initial results from an ongoing clinical trial of its Northera neurogenic orthostatic hypotension (NOH) drug is not enough to undo the complete response letter it received in March, the orphan-drug maker says.

Drugmakers are paying anywhere from $3 billion to $5 billion annually for clinical trial procedures that may not be necessary, a new study concludes.

Sen. Chuck Schumer (D) is asking the FDA to finalize a long-standing proposed rule calling for stricter warning labels on opioids for pregnant and lactating women.

Purdue Pharma is denying reports it plans to seek FDA approval for pediatric OxyContin, despite an ongoing clinical trial studying the painkiller in children ages six to 16.

Drug companies will have to submit updated safety and efficacy data, as well as an updated analysis of a drug’s risks and benefits when renewing marketing authorizations in the EU, according to an European Medicines Agency (EMA) final guideline on processing renewal applications.