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BIO 2016

Commissioner Califf commits to tackling staffing issues at US FDA

Image: iStock/NicoElNino

23-Jun-2016 - Automated systems and reducing hiring time will be crucial in revamping the US FDA’s “antiquated” HR systems, says Commissioner Robert Califf.

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India to rewrite 75-year old drug laws with an eye on business, biologics and devices

23-Jun-2016 - India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.


Three drug wholesalers have failed GDP checks according to Czech regulator

22-Jun-2016 - Czech regulators say three drug wholesalers have “seriously violated” good distribution practices (GDP) guidelines.

Opko extended-release kidney disease drug approved after Catalent 483 delay

22-Jun-2016 - The US FDA has approved Opko Health’s kidney disease drug Rayaldee, delayed by almost three months due to manufacturing concerns at its CMO Catalent.

Scancell stops dosing in long-term trial of cancer vaccine SCIB1

21-Jun-2016 - Scancell Holdings has stopped dosing in a long-term extension arm of a trial of its cancer vaccine SCIB1 after discovering the product is no longer within original specification.

Comparing and FDA review for accuracy and completeness

20-Jun-2016 - Clinical trial sponsors are required by law to report results to; however it’s not clear if these posts are complete and accurate.

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Cheryl Laboratories added to US FDA "Red List" after refusing to allow inspection

20-Jun-2016 - The US FDA has drug manufacturer Cheryl Laboratories from shipping products to the US after the CMO stopped inspectors from visiting its facility in Navi Mumbai, India.

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CDSCO working on new Drug and Cosmetics Act; calls for input

16-Jun-2016 - Indian regulator CDSCO is developing a new Drug and Cosmetics Act that is more in keeping with the modern pharmaceutical industry.

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