NECC Crisis Festered in Ambiguity That Reigns Over Compounding

As FDA, Congress and the courts stumbled, compounding pharmacies such as NECC took advantage of a gray area of the law. Legislators will get another try; one proposed subjecting such pharmacies to cGMP requirements.

The fungal meningitis outbreak traced in September to steroids from the New England Compounding Center is forcing Congress to revisit a gray area of the law that has frustrated regulatory authorities for years.

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

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Brazil Pilots Digital Drug Pack Inserts

 

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Robert Califf Stabilized US FDA, His Departure May Signal A Coming Storm

 

The two-time FDA commissioner resigned on 20 January as part of the administration change. Califf is credited with righting an agency demoralized from the COVID-19 pandemic, but worries about its future are high.

US FDA Commissioner Califf’s Farewell Visit To Capitol Hill

 

Robert Califf’s final appearance on Capitol Hill as US FDA commissioner, a 5 December Senate hearing focused on the agency’s food and nutrition functions, was an appropriate coda to his tenure and preview of things to come under the Trump Administration.

EMA Pushes For Industry Collaboration On Psychiatric And Psychedelic Drug Innovations

 

The European Medicines Agency wants to work with other regulators as well as industry, scientists and patients to “find solutions for the most pertinent problems in psychedelic research” and improve treatment options for psychiatric disorders more broadly, says the agency.