Side-effect reports to the FDA are a contentious subject. Despite a series of efforts to improve adverse-event reporting, numbers from the agency's database tend to be quoted with an accompanying list of disclaimers. But is the Federal Adverse Event Reporting System more reliable than we think?
The FDA reported last week that for about 6 months it has been testing some generic drugs to see how they stack up to the branded products they mimic. That $20 million effort is laudable, but it isn't enough to ensure the generics that fill the medicine cabinets of U.S. consumers are both safe and effective, according to critics of foreign-made pharmaceuticals.
The India-based generics maker pleaded guilty to U.S. drug safety violations and agreed to pay $500 million in penalties, in the largest-ever federal settlement with a maker of copycat drugs.
Smelly pills have led to another recall by Pfizer and this time a drug shortage. Last year Pfizer recalled more than 650,000 bottles of Advil gel tabs from stores because they had a strong odor. This time it is Pfizer subsidiary King Pharmaceuticals recalling 52,000 bottles of its thyroid pill Levoxyl because of a bad odor.
India's struggles to regulate its booming clinical research industry are well told, but now China could be headed down the same path, as a Beijing court has taken issue with how trial-runners pay compensation to patients.
Troubled BioCryst Pharmaceuticals has ditched its preclinical hepatitis C virus program of BCX5191 and its backup compounds after results of a low-dose chimpanzee study, according to documents filed with the SEC.
It's a state court ruling. It directly affects only one drugmaker. But the Alabama Supreme Court's decision to allow a patient to sue Pfizer for damages could ripple through the industry--and not in a good way for branded drugmakers.
An investigation into the deaths of 35 people in Gujranwala, Pakistan, tied to a cough syrup has sparked a controversy over who is to blame.
Congressional Democrats are ramping up two bills intended to put generic drugmakers on par with their Big Pharma counterparts as far as governing how they change product labeling to report updated safety information.
Sandoz Canada is in the spotlight again this week after Canadian health officials told hospitals to quarantine boxes of the company's injectable morphine after one was found to contain another drug.