The process of selecting clinical trial sites and launching studies, beginning with site identification and ending with study start-up completion, takes an average of 31.4 weeks, a full month longer…
As part of its heightened focus on data integrity the FDA has increased the sophistication of its inspections to identify hard-to-find data violations, according to a former CDER official who…
Investigations and lawsuits against opioid manufacturers and distributors continued as Sen. Claire McCaskill (D-Mo.) accused a drugmaker of blocking a Senate investigation and the city of Chicago sued three distributors.…
FDA Commissioner Scott Gottlieb called the drug contracting system “rigged” in remarks Wednesday at the America’s Health Insurance Plans National Health Policy Conference in Washington, D.C. Source: Drug Industry Daily
The FDA hit Chinese firm Zhejiang Ludao Technology with a warning letter after an August inspection revealed significant testing issues at its Taizhou, Zhejiang facility. Source: Drug Industry Daily
CBER’s advertising and promotional labeling branch sent an untitled letter to a drugmaker in Pennsylvania saying the company overpromised the impact of its hemophilia treatment. Source: Drug Industry Daily
Opioid sales increased more than eightfold between 1992 and 2015, according to a new analysis by the FDA that found no clear links between price and volume. Source: Drug Industry…
The Drug Enforcement Administration told an Ohio federal judge it would divulge nearly a decade’s worth of data on opioid sales after long resisting the disclosure, but only under a…
The FDA issued Kath Chemicals a Form 483 after an inspection of its Sterling Heights, Michigan facility revealed problems with batch reviews, product testing and cleaning, among other deficiencies. Source:…
Health Canada issued an updated risk classification guide to ensure consistent decisions by agency inspectors when classifying GMP observations by risk and assigning overall compliance ratings to an inspection. Source:…