We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Clinical Trials Transformation Initiative is developing several new sets of recommendations relating to clinical trials — on the qualification of investigators, the potential legal and regulatory hurdles to decentralized trials, and obstacles to incorporating mobile technology, according to its 2017 annual report. Read More
An FDA advisory committee voted Thursday that Infocare’s NDA for stannsoporfin injection’s overall risk-benefit profile does not support the drug’s approval. Read More
The administration is considering whether to revisit if drug companies’ rebates should be allowed safe harbor from anti-kickback laws in an effort to help curb rising healthcare costs, FDA Commissioner Scott Gottlieb told the Food and Drug Law Institute’s annual meeting in Washington, D.C. Read More
The sponsor found a statistically significant benefit from plazomicin over colistin for 28-day mortality in the bloodstream infection subgroup. Read More
The judge dismissed the remaining claims, saying they did not meet the threshold for whistleblower lawsuits as they cited third-party sources. Read More
The FDA Antimicrobial Drugs Advisory Committee voted 15-0 that Achaogen’s NDA for plazomicin proved safety and effectiveness for complicated urinary tract infections in patients with limited or no treatment options. Read More
The FDA finalized guidance on assessing user fees under PDUFA VI — covering fiscal years 2018 through 2022 — describing the new fee structure and the types of fees organizations are responsible for under the act. Read More
The agency noted that Health Canada-implemented ICH guidances take precedence over its existing guidances and said it is working to remove any inconsistencies. Read More
The U.S. Patent Trial and Appeal Board ruled in February 2017 that CRISPR patents granted to the Broad Institute for use in eukaryotic cells would stand. Read More