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India’s national drugs authority is again surveying pharmacists and testing drug samples in an effort to better grasp the extent of the country’s counterfeit and substandard drugs problem. Read More
Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
The FDA unveiled a broad plan that will change the way it inspects drugmakers, approves recalls, issues and reviews enforcement decisions, screens imports and tests products for quality, with drugmakers likely to start feeling the impact by the end of 2015. Read More
FDA investigators will be able to photograph most areas of a facility during an inspection, including product labels and visible contamination of materials, according to a final guidance issued last month. Read More
To make it easier for generics firms to create versions of complex drugs, the FDA is asking industry to identify drug products it would like to see bioequivalence testing guidances written for. Read More
The National Institutes of Health has launched a website that it says should help drugmakers plan and implement clinical research across the globe. Read More
FDA regulations have gotten more restrictive and lengthy, with new data showing a double-digit increase in the percentage of regulatory restrictions from 2000 to 2012. Read More
The UK’s health care costs regulator is recommending Boehringer Ingelheim’s anticoagulant Pradaxa as an option to treat and prevent recurrent and potentially fatal blood clots in the legs and lungs. Read More
Cipla has asked the Indian government to forcibly revoke five patents covering Novartis’s lung disease drug Onbrez to pave the way for generic versions in the country, a move the Indian manufacturer says is needed to address a significant unmet need for the therapy. Read More
Indian companies that export active pharmaceutical ingredients to the European Union can use six months of long-term stability data rather than 12 months, under a new rule that relaxes the time period requirement to show conformity with good manufacturing practices standards. Read More