White House Reiterates Confidence In FDA Expertise, Independence With J&J Vaccine Pause

Not only did White House and other officials support the recommendation, but also made clear they had no advance notice of it.

White House and other officials affirmed their confidence in the US Food and Drug Administration and the Centers for Disease Control and Prevention after the agencies caused a stir by recommending a pause in administration of the Janssen Biotech Inc. coronavirus vaccine because of concerns about rare blood clots.

FDA and CDC officials announced 13 April that six cases of cerebral venous sinus thrombosis in combination with thrombocytopenia had been seen a few days after the J&J shot had been administered in women age 18 to 48

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Safety Review Prompts EMA to Suspend Ixchiq Chikungunya Vaccine For Seniors

 

The European Medicines Agency is investigating whether Valneva’s Ixchiq is safe to use in the elderly, following reports of 17 serious adverse events, including two cases resulting in death, in people aged 62 to 89 years who received the vaccine. This follows actions by US and French authorities last month regarding Ixchiq’s use in people over 65.

Opioid Safety: US FDA Hears Mixed Messages On Adding Posmarketing Studies To Labeling

 
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Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.

US FDA Asks Adcomm If Opioid Postmarketing Studies Are Relevant, Warrant Action

 
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Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.

US FDA Commissioner Makary Wants To Combine Adverse Event Reporting Systems

 

In discussing FDA’s adverse event monitoring, Makary also seemed to falsely imply the agency did not fully investigate the myocarditis signal with COVID-19 vaccines.

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US FDA Restoring Some Library Resources

 

Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.

Recent and Upcoming FDA Advisory Committee Meetings

 
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.