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Latest From Drug Safety
Filing stays litigation but state attorneys general will be battling company's settlement proposal in US bankruptcy court. Details emerge on Purdue finances, rebate expenditures and litigation costs.
Pharmacy petitions for recalls after finding ‘inherent instability’ in antacid that could pose carcinogenic risk.
Many stakeholders interviewed by the GAO find the US FDA's updated guidance on treatment of adverse event data gathered under expanded access to be helpful, but some continue to be concerned that the data will be used to negatively impact development programs.
Ellis Unger tells the Pink Sheet that Premarket Safety Assessment Working Group is overseeing various projects aimed at bringing more standardization to NDA and BLA safety assessments across applications and review divisions, while also bolstering the quality of those reviews; initiatives include development of queries that group similar types of adverse events together and standardizing the safety information requested at pre-NDA meetings.
A major new study showing that the risk of breast cancer in women taking hormone replacement therapy is double previous estimates has prompted UK and EU regulatory agencies and England’s health technology assessment body to look further into the matter.
Yell It From The Rooftops: Hep C Drug Safety Notice Another Example Of FDA's Limited Power Over Prescribers
After its bully pulpit, the US FDA's options to encourage physicians to follow labeling recommendations for hepatitis C drugs are limited.
Rejection of Sarepta’s golodirsen has become latest flashpoint in debate over release of complete response letters. In this case, though, FDA’s reasoning seems fairly obvious, based on the prior eteplirsen review.
A review of barriers to the prescribing of cannabis-based medicines for children with epilepsy in England suggests that much needs to be done to generate the necessary evidence to assuage prescribers’ concerns.
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