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The European Medicines Agency (EMA) says the EU’s EudraVigilance database received more than 1 million post-marketing expedited adverse-drug-reaction (ADR) reports in 2013. Read More
Manufacturers estimate that a medium-sized drugmaker would have to pay roughly $36 million to implement a serialization and traceability system required under the new federal track-and-trace law. Read More
Drugmakers providing postmarket benefit-risk assessments to Health Canada will soon need to follow rigid, standardized guidelines that provide both preapproval and postapproval data about a drug product’s efficacy. Read More
The Arkansas Supreme Court declined to hear an appeal of its decision to reverse a $1.2 billion verdict against Johnson & Johnson over the practices the company used to market the antipsychotic Risperdal. Read More
The European Commission is moving toward putting new restrictions on drugs that contain domperidone, removing the EC’s approval of the drugs for treatment of bloating and heartburn due to increased heart risks. Read More
Hospira’s quality struggles continue as the injectable giant voluntarily recalled seven lots of generic anesthetic propofol due a defect that led to metal particles in certain vials. Read More
Glenmark Generics, U.S. subsidiary of India-based Glenmark Pharmaceuticals, has recalled a lot of generic ranitidine 150 mg tablets after a pharmacist complained that one bottle of the drug contained 50 mg metoprolol tartrate tablets instead of the intended drug. Read More
Drugmakers must now give Brazil’s Anvisa a full year’s warning before withdrawing a product from the market if the withdrawal could result in a drug shortage. Read More
Australia’s Therapeutic Goods Administration said recently it is evaluating the potential safety risks with Biogen Idec’s multiple sclerosis drug Tysabri following reports of melanoma in patients using the drug. Read More