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Veterans Health Administration officials are still not routinely checking records before writing opioid prescriptions, not regularly testing patients to make sure the drugs are being used properly and not properly securing informed consent before putting veterans on long-term opioid programs, according to the Government Accountability Office. Read More
More than three dozen state attorney’s general wrote Congress in support of bills that would increase penalties for opioid manufacturers that fail to report suspicious orders. Read More
Patients with tears in their digestive tracts should generally be excluded from clinical trials of drugs designed to treat complicated intra-abdominal infections, the FDA says. Read More
Despite opposition from some stakeholders, the European Commission proposes to grant waivers to Europe’s drugmakers to produce generic drugs for export to countries outside the EU. Read More
The announcement “likely signals that China is gearing up its enforcement efforts and looking into those industries that are most prone to corruption risk, particularly the pharmaceutical industry,” the attorneys said. Read More
An administrative law judge tossed out the Federal Trade Commission’s complaint challenging an agreement between Impax Laboratories and Endo Pharmaceuticals that the FTC claims illegally kept a generic version of the opioid pain medication Opana ER off the market. Read More
FDA officials indicated that the shortest median time to meaningful pain relief in the pivotal trial was 92 minutes — longer than the hour in which patients generally expect pain relief to take effect. Read More