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The FDA is moving to ease industry fears that ANDAs filed after September of this year will receive priority over earlier applications simply because they were filed before the law required the agency to assign review deadlines to new applications. Read More
A new bipartisan House bill would stop brandmakers from relying on a drug-control program to deny generics firms the batch samples they need to put together an ANDA. Read More
GlaxoSmithKline must pay a fine of roughly $490 million and change its business practices in China after a Chinese court found the company guilty in a year-old bribery case. Read More
The UK’s health-cost watchdog said it’s not ready to change the way it appraises medicines and other technologies, but acknowledged that further consideration is needed on how new treatments are developed, evaluated and supported for adoption in the National Health Service (NHS). Read More
Generics makers with first-to-file ANDA status say they are frustrated by the FDA’s slow approval times, claiming their 180-day market exclusivity period is jeopardized by agency inaction. Read More
The FDA’s database of inactive drug ingredients needs a complete overhaul to better facilitate ANDA filings, say generics makers, that laid out a variety of other shortfalls they see in the agency’s generic drug approval process. Read More
Indian pharmaceutical authorities have collected only $62 million, or roughly 9 percent, of the $688 million they say drugmakers owe in fines for the overcharging of drugs. Read More
Generic drugmakers submitting ANDAs that indicate impurities in proposed products that exceed established thresholds must provide detailed justification to avoid having the application rejected, the FDA said. Read More
A new report from the Italian Medicines Agency says that 10 percent of Italian hospitals register pharmaceutical thefts, a problem that the European pharmaceutical industry hopes to end with a pan-European verification system set to go live by 2017. Read More
The European Medicines Agency has issued revised guidelines that aim to ease overly burdensome postmarket monitoring and reporting requirements under the EU’s 2010 good pharmacovigilance practices (GVP) regulations. Read More