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When President Obama signed the Drug Quality and Security Act into law in November, it immediately preempted all state measures for track and trace and established one federal system for pharmaceuticals. Read More
With the new pharmaceutical track-and-trace law’s deadline for lot-level pedigrees looming, the FDA is still unclear about how it will regulate the complex requirement. Read More
The FDA may refine its planned quality metrics program to include rankings of individual drugmaker quality — at the request of industry — that will show how a company’s quality system stacks up against its peers. Read More
Novel Laboratories failed to adequately address black specks on drug products and pieces of rubber found in a product container, according to a Form 483 given to the drugmaker. Read More
Roche subsidiary Genentech received a Form 483 from the FDA after an inspection found parts of the processing area for making active pharmaceutical ingredients (APIs) was covered with what resembled rust. Read More
China’s Food and Drug Administration (CFDA) is renewing its push to have all manufacturers of blood products, vaccines and sterile injectables obtain a revised good manufacturing practices (GMP) certificate. Read More
A new analysis of opioid availability in 104 countries suggests regulators in emerging markets increasingly important to industry are hindering sales of opioid painkillers to cancer patients. Read More
Generic drugmakers are pushing back against proposed new tight deadlines for responding to FDA questions about ANDAs, and the industry also wants the agency to show greater leniency in dealing with deficiencies in applications. Read More
The FDA, showing no signs of easing its advertising and marketing enforcement, has rapped DARA BioSciences for omitting risk information about its cancer drug Soltamox in a sales aid. Read More