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FDA’s Priority Reviews May Have Helped Reduce New Drug Shortages

 
• By Michael Cipriano

But agency's policy changes have failed to ameliorate ongoing shortages, GAO finds.

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FDA’s priority review of drug applications and supplements may have played a part in reducing the number of new drug shortages over the past five years, the Government Accountability Office (GAO) says.

According to a report by the government watchdog, new drug shortages have generally decreased each year from 2011...

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No ‘Doomsday’ For US Pharma Despite Political Uncertainties, EU Industry Chief Says

 
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While challenges in the US present an “incredible opportunity” for Europe, there is no “doomsday” happening there, Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says.

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

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Industry Criticizes Dutch Decision To Slash PARP Inhibitor Reimbursement

 
• By Francesca Bruce

ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.

EU Biosimilar Filings, Opinions And Approvals

 
• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 
• By Bridget Silverman

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.