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Making Imodium Rx-Only No Help On Curbing Opioid Abuse – CHPA

 
• By Eileen Francis

Making OTC diarrhea remedy loperamide Rx-only is unlikely to reduce abuse and would cause problems for millions of US consumers who depend on the product, says the Consumer Healthcare Products Association, responding to a petition advocating the change.

Making all loperamide-containing diarrhea remedies Rx-only is unlikely to reduce abuse and misuse of the drug but would unfairly limit access for millions of consumers who use OTC versions safely, says the Consumer Healthcare Products Association.

In a Sept. 5 letter to FDA, Jay Sirois, CHPA's senior director of regulatory and scientific affairs, suggests...

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• By Bridget Silverman

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CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 
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US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
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ACIP Members ‘Not Easy’ To Find After Clean Sweep, US CDC Director Nominee Says

 
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EU Health Chief Declares There Is No Better Alternative Than TEVs to Spark Antibiotic Innovation

 
• By Francesca Bruce

Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.

EU Fines Alchem Over Buscopan API Cartel

 
• By Dave Wallace

After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

 
• By Eliza Slawther

Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.