Galena Biopharma agreed to pay more than $7.5 million to settle a whistleblower suit alleging the drugmaker violated the False Claims Act by paying doctors to prescribe its fentanyl-based drug…

Drug companies can move beyond simply satisfying FDA regulations by meticulously tracking quality elements, Baxter International quality expert Kevin Cloonan said Monday at the PDA/FDA Joint Regulatory Conference in Washington,…

The FDA’s Pediatric Advisory Committee voted overwhelmingly that the risks outweigh the benefits of using opioids to treat coughs in children. Source: Drug Industry Daily

FDA commissioner Scott Gottlieb highlighted the agency’s efforts to improve clinical trials during a keynote address Monday at the RAPS’ 2017 Regulatory Conference. Source: Drug Industry Daily

A federal appeals court rejected a challenge by Otsuka Pharmaceuticals to the FDA’s decision to deny exclusive marketing rights to Otsuka’s antipsychotic injectable Abilify Maintena vis-a-vis a competing antipsychotic drug.…

FDA researchers are developing methods to examine and control chemical reactions that can impact the shelf-life, quality, safety and efficacy of protein-based biopharmaceuticals. Source: Drug Industry Daily

The ICH has finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Source: Drug Industry Daily

An FDA advisory committee voted 13-to-1 in favor of adding a warning about the risk of gadolinium retention to prescribing information for gadolinium-based contrast agents used in MRI scans. Source:…

The FDA cited a Chinese drug and API facility for a slew of violations of agency standards, based on an inspection of the company’s plant in Tianmen. Source: Drug Industry…

Shortly after taking office in January, President Trump issued an executive order directing agencies to identify regulations considered to be outdated, unnecessary or ineffective; inhibit job creation; or impose costs…