Archive for May 2018

FDA Commissioner Scott Gottlieb said the agency may ask Congress for more authority to deal with intravenous drug shortages but he also called for voluntarily collaboration by the industry. Source: Drug Industry Daily

In the latest development over alleged misconduct by Insys in promoting its fentanyl-based opioid Subsys, a former sales representative admitted to participating in a scheme to bribe doctors to prescribe the drug under the pretext of paying speaking fees. Source: Drug Industry Daily

The FDA called out brand drugmakers for using REMS to delay and block competitive generic drugs, announcing two draft guidances designed to help generic drug makers get their products to market and preserve the safety controls intended by REMS. Source: Drug Industry Daily

The FDA released the ICH’s Q12 draft guidance on pharmaceutical product lifecycle management (PLCM) for post-approval changes in chemistry, manufacturing and controls. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily

The FDA issued a warning letter to Jilin Shulan after an inspection of the firm’s Shulan City, Jilin Province facility revealed significant GMP deviations for active pharmaceutical ingredients. Source: Drug Industry Daily

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily