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Tainted Supplement Recalls Prompt Call For Tighter Regulations – Letter

 
• By Lisa Gillespie

A research letter says that tainted supplements accounted for more than half of class I recalls from 2004-2012, and the researchers argue for stricter regulation. Industry points to a steep drop-off after 2010, and call for stronger enforcement of existing regulations.

The authors of a research letter showing adulterated supplements accounted for 51% of class I recalls over a nine-year period say the evidence supports stricter regulation for dietary supplements.

Supplement advocates, however, point out the data show a drop-off in such recalls since FDA announced it was targeting products...

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More from Post-Marketing Regulation & Studies

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By Mandy Jackson

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

After Sarepta Reversed Course On Elevidys, Could An Adcomm Be Next?

 
• By Derrick Gingery and Mandy Jackson

One option for the FDA going forward could be holding an advisory committee meeting on its safety concerns after Sarepta agreed to stop all shipments of its DMD gene therapy.

Sarepta Refuses To Stop Elevidys Shipments After Third Death Linked To Gene Therapy Vector

 
• By Mandy Jackson

Sarepta knew about the death in a Phase I trial of SRP-9004 for LGMD when it recently revealed a restructuring plan, but did not disclose the event. The now-discontinued gene therapy candidate uses the same AAV vector as Elevidys, which has been linked to two DMD patient deaths.

US FDA Advisory Committee Supports Vaccine Safety, Scrutinizes AE Reporting Quality

 
• By Sue Sutter

The Pediatric Advisory Committee supported routine safety monitoring for three vaccines and 21 drugs, but the panel’s consumer representative said adverse event reporting needs improvement and FDA literature reviews should include lawsuits as well as social media.

More from Product Reviews

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
• By Neena Brizmohun

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.