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FDA Signals Progress In War On Adulterated Supplements

 
• By Dan Schiff

CDER data show class I recalls of supplements spiked with undeclared drug ingredients fell dramatically the past two years after peaking in fiscal 2010.

A dramatic decline in recalls of adulterated dietary supplements suggests FDA’s collaboration with industry to crack down on such illegal products is bearing fruit.

Data from FDA’s Center for Drug Evaluation and Research show class I recalls of products labeled as supplements but containing undeclared active pharmaceutical ingredients peaked at 131 in...

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More from Post-Marketing Regulation & Studies

EMA Touts Faster Global Post-Approval Changes Via Regulatory Reliance

 
• By Eliza Slawther

The European Medicines Agency says that a regulatory reliance pilot that it is supporting to speed up assessments of post-approval changes appears to be accelerating evaluation timelines in non-EU countries.

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

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

 
• By Sue Sutter

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.

Updated: Makary Backs New Novavax COVID-19 Trial, Political Officials Take Over Product Review

 
• By Sarah Karlin-Smith

In an unusual move, Tracy Beth Høeg, a special assistant to FDA Commissioner Martin Makary, is leading the continued negotiations on Novavax’s delayed COVID-19 vaccine approval.

More from Product Reviews

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.