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Not all clinical trials need to be registered on clinicaltrials.gov, so sponsors need to understand the specific elements that determine if their trial is applicable to those reporting requirements, an expert says. Read More
Makers of drugs to treat opioid-induced constipation need not conduct further large, long-term cardiovascular outcomes safety trials, an FDA advisory panel tenuously concluded June 12, noting that it may be wiser to require postmarket observational studies. Read More
The Therapeutic Goods Administration is considering adopting 15 EU guidelines relating to drug development, including guidance on biosimilars, lipid disorder therapies and bacterial infections. Read More
Indian generics maker Ranbaxy will pay $2.3 million for selling drugs in Oregon that were manufactured in violation of current good manufacturing practices. Read More
French drugmaker Servier and five generics firms are facing roughly $580 million in fines from European antitrust regulators over an alleged pay-for-delay scheme. Read More
Biologics makers planning new genetically engineered drugs derived from viruses and bacteria need to conduct studies to demonstrate whether their product can inadvertently be transmitted to other patients, the FDA says in new draft guidance. Read More
The new rule establishing FDA powers to destroy suspected counterfeit and adulterated drugs could cause shortages if the agency doesn’t protect against officials destroying needed excipients that get caught up in an import dispute, according to PhRMA. Read More