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The FDA is investigating reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in women over 165 lbs. and don’t work at all for women over 175 lbs. Based on its review, labeling changes for the drugs may be forthcoming. Read More
Three years after placing heavy restrictions on GlaxoSmithKline’s type 2 diabetes drug Avandia, the FDA said Monday it is relaxing those restrictions in line with its advisers’ recommendations. Read More
Amgen is the latest drugmaker caught up in the FDA’s recent flurry of enforcement letters for false or misleading promotional materials. An ad developed by the company for its anemia drug Aranesp omitted risks and inflated efficacy claims, the agency says. Read More
EU regulators on Friday assured Ariad that its leukemia drug and sole product Iclusig can continue to be sold throughout Europe for its approved indications. Read More
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
Drugmakers have 13 months to revamp how they track drugs after the Senate voted Nov. 18 to send to President Barack Obama’s desk a measure that would establish a nationwide track-and-trace requirement for prescription drugs. Read More
The European Commission (EC) is threatening to take legal action against Italy, Poland, Slovenia and Finland for failing to implement the Falsified Medicines Directive, an EU-wide anti-counterfeit initiative that has been in effect since Jan. 2, 2013. Read More
Shortly after Duchesnay received FDA approval for its morning sickness drug Diclegis, the agency says the Canadian drugmaker sent a letter to customers touting the drug’s benefits but none of its risks. Read More
The European Medicines Agency (EMA) has concluded a review of adverse event reporting deficiencies at Roche, concluding the company’s failure last year to report adverse events for 19 drugs did not cause any additional risks to consumers. Read More
Tamper-evident packaging and registered product trademarks are two features Johnson & Johnson (J&J) employs to minimize a product’s risk of being counterfeited or diverted. Read More
Sponsors of medical device clinical trials should avoid recruiting and putting at risk an unnecessarily large number of patients, a new guidance by the UK’s Medicines and Healthcare products Regulatory Agency says. Read More
For the first time brand and generic drugmakers are required to notify the EMA and individual country regulators when they withdraw a drug from the market anywhere in the EU, and the reasons why, to comply with the EU’s newly amended pharmacovigilance law. Read More