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The FDA is currently recruiting and training seven investigators for its India office, growing the agency’s in-country American staff acting from 12 to 19. Read More
Drugmakers should clearly define their validation activities in a validation master plan that accounts for the lifecycle of a product and related plant equipment, the European Commission says. Read More
Israeli-owned RedHill Biopharma and Canada’s IntelGenx have received a complete response letter from the FDA for their RHB-103 migraine drug, which cites problems with the pharma partners’ third-party chemistry, manufacturing and controls, packaging and labeling issues. Read More
The FDA has upgraded the status of Hospira’s troubled Rocky Mount, N.C., manufacturing plant to allow it to begin using the facility to manufacture new products. Read More
The EU’s new pharmacovigilance law could cost drugmakers fees totaling as much as $330,000 for each drug they make to cover postmarketing assessments. The EU proposed the fees, divided into two categories, Thursday as a way to pay for the reviews mandated under the 2010 law. Read More
European regulators have turned down drugmakers’ requests to allow generic labeling of pandemic vaccines, which sponsors argue would help get their drugs to patients much sooner. Read More
When drugmakers change analytical validation methods during a drug’s lifecycle, the FDA says they should archive product samples to permit comparative studies of the old and new validation methods. Read More
Purdue Pharma wants immediate-release opioids subjected to the restrictive labeling and postmarketing studies now required for extended release and long-acting (ER/LA) products such as the company’s flagship drug OxyContin. Read More
The FDA and European Medicines Agency (EMA) have launched a new information-sharing initiative they hope will coordinate and speed international responses to drug safety problems. Read More
Dynavax is withdrawing a European marketing authorization application for the Heplisav hepatitis B vaccine over concerns with adequate safety information. Read More