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The FDA released the ICH’s Q12 draft guidance on pharmaceutical product lifecycle management (PLCM) for post-approval changes in chemistry, manufacturing and controls. Read More
The FDA recommended systemic characterization of a drug’s effect on blood pressure during drug development in newly issued guidance, which addresses precision of blood pressure measurements in assessing the effects of short-term and chronic use drugs in development. Read More
A lower court’s dismissal of a whistleblower lawsuit against Otsuka and Bristol Myers-Squibb will stand, as the U.S. Supreme Court this week declined to hear the case. Read More
President Trump on Wednesday signed into law the Right-to-Try Act establishing a pathway for terminally ill patients to use non-FDA-approved drugs, calling the legislation “great for the people” and a “fundamental freedom,” but it was a castoff remark he made about lower drug prices that had everyone talking. Read More
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