29-Jun-2016 - Set standards for Phase I trials could stop serious adverse events and patient deaths, says a DIA panellist discussing the recent Bial trial tragedy.
29-Jun-2016 - Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.
28-Jun-2016 - The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.
28-Jun-2016 - Indian companies in the UK are among many in the pharma industry facing an uncertain future after Britain voted to exit the single-market last week.
27-Jun-2016 - The pharma industry is underprepared for the upcoming global regulations says Recipharm, which has inked three new tech deals as part of its €40m serialisation effort.
24-Jun-2016 - Japan “welcomes innovation” as it makes significant investments in infrastructure and regulatory changes.
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.
23-Jun-2016 - India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines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.
22-Jun-2016 - Czech regulators say three drug wholesalers have “seriously violated” good distribution practices (GDP) guidelines.
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.
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.
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.
17-Jun-2016 - The US FDA has banned Phalanx Labs from shipping products to the US after the Indian API and intermediates firm refused to let inspectors visit its site in Visakhapatnam.
16-Jun-2016 - A plan to charge drug firms more to import APIs into India has won the support of the Government’s Drugs Technical Advisory Board (DTAB).
16-Jun-2016 - Indian regulator CDSCO is developing a new Drug and Cosmetics Act that is more in keeping with the modern pharmaceutical industry.
15-Jun-2016 - The UK MHRA has identified GMP deviations at two manufacturing sites operated by US firm Pharmaceutics International Inc (PII).
15-Jun-2016 - The Taiwanese drugmaker stopped shipping products to the US after an FDA inspection but failed to commit to corrective actions, states a warning letter published this week.
14-Jun-2016 - French authorities have started a manslaughter investigation in connection with a Ph I trial conducted by Rennes-based CRO Biotrial in which one volunteer died and five others were hospitalised.
13-Jun-2016 - CDSCO has renewed a number of API firms’ ‘written confirmation’ documents – which are needed to ship to Europe – days after an industry group called for renewals without re-inspection citing trade concerns.
13-Jun-2016 - The UK MHRA has identified GMP deficiencies at an Akums Drugs & Pharmaceuticals facility in India that was being lined up to make progesterone for Nordic Pharma.
It is well known that implementation of Rapid Microbiological Methods in Pharma environments is accompanied by a large validation work...