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…

The FDA released the ICH’s Q12 draft guidance on pharmaceutical product lifecycle management (PLCM) for post-approval changes in chemistry, manufacturing and controls.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

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…

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…

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…

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…

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

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. Source: Drug Industry Daily

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. Source: Drug Industry Daily