Automated systems and reducing hiring time will be crucial in revamping the US FDA’s “antiquated” HR systems, says Commissioner Robert Califf.
India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines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.
Biogen will shutter a bioproduction facility in Massachusetts by the end of the year if it fails to find a buyer.
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.
Czech regulators say three drug wholesalers have “seriously violated” good distribution practices (GDP) guidelines.
AMRI has licensed technology needed to make an analytical standard drug firms working with cannabinoids can use for research and quality control.
Juniper Pharma Services has invested in a tablet press that can produce 42,000 pills an hour citing customers’ clinical trial supply needs as the driver.
Collegium Pharmaceutical has launched the first product formulated using its Deterx anti-abuse technology in the US.