Simplifying Global Compliance
Items Tagged with 'risk'
The FDA has started a new program to reassess risk-benefit determinations for certain new molecular entities 18 months after they’re approved, according to CDER Director Steven Galson. Read More
The European Medicines Agency (EMEA) has published a draft guideline describing scientific principles and methodology for conducting environmental risk assessments (ERAs) of gene therapy medicinal products that contain genetically modified organisms, or GMOs. Read More
Sponsors wishing to test high-risk new drugs for the first time on human subjects are advised to undertake additional preliminary studies in some circumstances, under a new draft guideline from the European Medicines Agency (EMEA). Read More
Advocacy group Public Citizen has asked the FDA to ban what it calls a "dangerous, misleading" TV ad for Pfizer's arthritis pain medicine Celebrex. Read More
Individual adverse events in clinical trials are not necessarily the same thing as unanticipated problems and may not have to be reported as such to the institutional review board (IRBs), according to new draft guidance from the FDA. Read More
As part of a Senate Finance Committee investigation, Sen. Chuck Grassley (R-Iowa) is requesting information from Eli Lilly regarding the marketing of its antipsychotic drug Zyprexa. Read More
The HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) under its new chairman, Samuel Tilden, has recommended ethics training for investigators, IRB members and others, and has proposed a definition of “minimal risk” clinical trials. Read More
Sponsors wishing to test new high-risk drugs for the first time in human subjects are advised to conduct additional preliminary studies in some circumstances under a new draft guideline from the European Medicines Agency (EMEA). Read More
Results from a recent open-label study showed that Pfizer’s antibiotic Zyvox increased the risk of death in patients with Gram-negative, catheter-related infections, according to an FDA MedWatch report issued March 16. Read More
Australia’s Therapeutic Goods Administration (TGA) has released a discussion paper aimed at improving access to consumer medicines information (CMI) and product information (PI). Read More
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