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One committee member voted “no” on the delay, saying “we do patients some potential benefit here if this agent is used constructively and intelligently while we wait for additional data.” Read More
The scheme involved fraudulent claims submissions to Medicare Part D plan sponsors for drugs that the pharmacy never ordered or dispensed to beneficiaries. Read More
A class action lawsuit filed in California claims Genentech took advantage of cancer patients by packaging oncology drugs in oversized vials. Read More
Several pharma industry trade groups and drugmakers wrote to the FDA to endorse a Pfizer petition asking the agency to take more aggressive steps against biosimilar-related misinformation. Read More
The FDA has issued final guidance clarifying its thought process for evaluating bulk drug substances that are being considered for the 503B bulks list, which specifies substances that outsourcing facilities may use in drug compounding. Read More
When food adversely affects a drug’s safety or efficacy, requiring fasted dosing, the sponsor should conduct studies to determine a realistic time interval between drug dosing and meals, the guidance states. Read More
According to the U.S. Attorney for the Eastern District of Pennsylvania, Lehigh received a waiver for its oxycodone hydrochloride NDA but then went on to secure two more waivers for NDAs relating to potassium chloride for oral solution. Read More
A federal judge ruled Teva can’t challenge the FDA’s new policy on generic exclusivity because the drugmaker has not proved a danger of imminent injury. Read More