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Drug Safety

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Latest From Drug Safety

Will Purdue Bankruptcy Filing Resolve 'Unrelenting Chaos' Of Opioid Litigation?

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.

Legal Issues Policy

FDA And EMA Evaluate Claims As Nitrosamine Worries Turn To Zantac

Pharmacy petitions for recalls after finding ‘inherent instability’ in antacid that could pose carcinogenic risk.

Manufacturing Quality

Expanded Access Program Improving, But Sponsor Concerns Linger

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.

Clinical Trials Drug Safety

US FDA Looks To Standardize Premarketing Safety Assessments

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.

Drug Review Drug Safety

HRT: European Agencies Scrutinizing New Higher Breast Cancer Risk Data

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.

Drug Safety Cancer

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.

Drug Safety Liver & Hepatic

Sarepta’s Golodirsen Rejection: Do We Really Need The US FDA’s Letter?

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.

Neurology Complete Response Letters

Endo And Allergan Could Edge Out Of Opioid Bellwether Trial Spotlight With Proposed Settlements

Companies reach agreements in principal with plaintiffs in bellwether trial in the US multidistrict litigation as court date nears; plaintiffs narrow their claims from 11 to seven.
Legal Issues Advertising, Marketing & Sales

NHS England Tackles Barriers To Use Of Cannabis-Based Medicines

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. 

United Kingdom Neurology
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