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Sponsors seeking marketing authorization for new drugs in the EU must now apply for a numerical code unique to the submission, the European Medicines Agency says. Read More
The UK’s Medicines and Healthcare products Regulatory Agency recorded a nearly 20 percent increase in complaints about drug advertisements in 2013 — the majority coming from companies complaining about their competitors. Read More
U.S. Food and Drug Administration Commissioner Margaret Hamburg said her 10-day trip to India succeeded in syncing U.S.-India views on quality of medical products. Read More
Drugmakers should test porcine trypsin, a starting material used in biologic drugs, just after it is produced to ensure material from a single infected pig doesn’t enter production batches, the European Medicines Agency says. Read More
The U.S. Food and Drug Administration and European Medicines Agency have launched a new information-sharing initiative aimed at speeding international responses to drug safety problems. Read More
The European Medicines Agency is advising drugmakers to create a separate program to assess the effectiveness of risk-minimization efforts for each marketed drug. Read More
Drug companies could pay as much as US $330,000 per authorized product to cover postmarketing assessments required by the EU’s new pharmacovigilance law, under fees proposed by European lawmakers. Read More
The FDA’s crackdown on compounders continues with two pharmacies receiving warning letters for compounding drugs without a prescription, mixing an unapproved drug ingredient into compounded products and failing to maintain sanitary facilities. Read More
The surge of opposition to Zogenix’s controversial painkiller Zohydro ER shows no signs of abating, with state officials joining congressional critics in calling for a reversal of the single-entity hydrocodone product’s approval. Read More
The FDA has rejected Avedro’s NDA for its riboflavin ophthalmic solution/KXL System, saying additional data supporting the drug-device combo’s efficacy and safety are required for approval. Read More
Australia’s Therapeutic Goods Administration (TGA) said Tuesday it is evaluating the potential safety risks of Biogen Idec’s multiple sclerosis drug Tysabri following reports of melanoma occurring in patients using the drug. Read More
The FDA has extended by three months the PDUFA-review date for Biogen Idec’s Plegridy, a drug candidate proposed to treat relapsing multiple sclerosis (MS), the drugmaker said Tuesday. Read More