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The FDA wants to know how a spouse may influence a partner’s perception of a direct-to-consumer drug advertisement, the second study examining a specific DTC ad scenario that the agency has announced this week. Read More
The FDA said two generic versions of Janssen’s attention deficit hyperactivity disorder drug Concerta may not be therapeutically equivalent to the brand, a decision that could result in the products being withdrawn. 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
Par Pharmaceutical said yesterday the FDA has approved its NDA for Vasostrict injection, making it the first product of its kind to win approval. Read More
A federal judge has finalized an agreement by Pfizer to pay $325 million to settle claims it marketed off-label uses of its epilepsy drug Neurontin. Read More
European regulators yesterday told the European Union ombudsman that they adhered to the law when allowing manufacturer AbbVie to redact information from its clinical study reports, marking the latest twist in the debate over European trial data transparency. Read More
A key Senate health panel will consider a bipartisan bill to hasten the development of Ebola drugs by including the disease under a lucrative voucher program. Read More
The European Medicines Agency has released an online tool designed to help manufacturers report and edit information on their marketed products, as required under the 2010 pharmacovigilance law. Read More
The Scottish Medicines Consortium has approved five new medicines for reimbursement in Scotland, including treatments for cancer, hepatitis C and diabetes. Read More
The European Medicines Agency has lent its support to an initiative to qualify biomarkers that can provide an early warning on an investigational compound’s risks of causing drug-induced kidney injuries, an endorsement that researchers say is necessary to move to the next phase of development. Read More
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