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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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News in brief

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23-Jun-2016 - India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines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

update

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 ClinicalTrials.gov and FDA review for accuracy and completeness

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

News in brief

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.

News in brief

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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