Enforcement on steroids: As expected, FDA enforcement went into overdrive last year. The warning letter rate doubled and punishments were swift and harsh. But that was just the beginning. The agency expanded its field force, and after a few years of training, its new investigators will bring it on. No more dithering about Form 483 findings. Import alert hits Apotex 10 days after inspection. KV gets consent decree just four weeks after inspectors find it failed to file field alerts. Ranbaxy ANDA reviews halted by FDA's GMP concerns, even though EU and WHO saw nothing wrong. FDA's criminal investigators will coordinate more with the rest of the agency and others. Last year's 34 warning letters harped on the same issues as before, but with a new focus on foreign API makers. FDA's new foreign offices focus on data integrity in India and GMPs in China. Congress showers FDA with money but further constrains its regulatory discretion. Expect Dingell's Globalization Act to decorate 2012 PDUFA Christmas tree
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.
The UK Health Research Authority’s latest three-year strategy sets ambitious targets to make research more transparent. One World Health Organization official believes the authority can go further by setting equally high standards for the timely reporting of clinical trial results.
Other authorities are expected to mirror the European Medicines Agency’s decision to lift the temporary restriction it placed on using Valneva’s chikungunya vaccine in people aged 65 years and older.
