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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
The FDA has slapped another Indian active pharmaceutical ingredient maker with a warning for data integrity weaknesses, including printing batch records from personal computers over which the company lacked adequate controls. Read More
The FDA chided drugmaker Sciecure Pharma for distributing a sales aid that touted overblown superiority claims and disregarded risk information surrounding its insomnia treatment Doral.
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The FDA has cited Cadila Pharmaceuticals for poor data integrity practices and sloppy investigations into foul smelling batches of active pharmaceutical ingredients (APIs), violations that the agency threatened could result in an import alert. Read More
The FDA is fleshing out its expectations for drugmakers that want to participate in the agency’s rare pediatric disease voucher program, offering new details on requirements for seeking the designation, a five-year post approval reporting schedule and procedures for transferring the vouchers. Read More
The head of the European Medicines Agency was forced to resign after a tribunal found he was improperly selected in 2011, a move agency officials characterized as a procedural issue. Read More
The drug pricing authority of India is calling on industry, public health experts and others to help update the country’s list of life-saving and essential drugs, a move that one observer says is needed to understand which drugs are on the market and under price controls. Read More
English health authorities next month will decide whether to stop reimbursing 25 cancer drugs because they are too expensive, a decision that has riled manufacturers who believe it will restrict patient access to treatments. Read More
Genentech’s cancer drug Avastin won approval Friday to treat platinum-resistant, recurrent ovarian cancer in combination with chemotherapy, marking the eighth time the FDA has greenlighted the blockbuster product. Read More