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Canada lags significantly behind other developed countries in providing coverage for new medicines, with Canadians waiting on average 462 days for novel, potentially lifesaving drugs, a new report shows. Read More
The number of critical deficiencies at pharma facilities registered in the UK nearly doubled from 2012 to 2013, spurred mainly by problems with data integrity, regulators say. Read More
The European Commission will revise four sections of its good manufacturing practice guideline and add a new one, as it moves to harmonize GMPs with international standards and speed the path to mutual reliance with foreign regulators, a UK official says. Read More
The U.S. Food and Drug Administration expects to boost its China office staff to 35 within the next two years and its India staff to 23 as the agency focuses on increasing inspections in both countries. Read More
India’s national drugs authority will hire 147 inspectors this year to ensure adherence to good manufacturing practices, but training will determine success, an observer says. Read More
Just as the U.S. Food and Drug Administration is ramping up inspections in China, Chinese regulators are increasing their oversight of overseas manufacturing operations, conducting 30 inspections so far in 2015. Read More
The U.S. Food and Drug Administration plans to provide guidance by year’s end on naming biosimilars, potentially ending much of the confusion over how the products will be labeled and tracked. Read More
All drug and biologic applications and drug master files must be submitted electronically by May 15, 2017, and all commercial investigational new drug applications one year later, under final guidance from the U.S. Food and Drug Administration. Read More
Sponsors of applications for drugs that are highly soluble in water but not easily absorbed through the intestines can now request waivers of studies proving the drug has a systemic effect or is equivalent to a reference product. Read More
The percentage of drug adverse event assessments leading to updated patient safety information in the EU nearly doubled between 2013 and 2014, from about 20 percent to 40 percent, a new report by the European Medicines Agency shows. Read More
Sponsors seeking EU authorization to market fixed-dose drug combinations should conduct multiarm, randomized, controlled trials comparing the FDC with its individual components, the European Medicines Agency says. Read More