A new FDA guidance was announced today in the Federal Register (emphasis added): FDA is announcing the availability of a draft guidance entitled “Guidance for IRBs, Clinical Investigators,[…]
An article in the October 2012 issue of Applied Clinical Trials describes a warning letter study that was undertaken by Rajendra Talele of Lambda Therapeutic Research and Dr. Suresh K. Bowalekar[…]
OHRP sent out an email update this morning regarding Superstorm Sandy’s potential disruption of IRB operations. The following actions are recommended for institutions and IRBs[…]
OHRP sent out an email update this morning regarding Superstorm Sandy’s potential disruption of IRB operations. The following actions are recommended for institutions and IRBs[…]
In mid-October, after studying the issue for more than a year, the Presidential Commission for the Study of Bioethical Issues issued its report on whole genome sequencing. The introduction gets[…]
In mid-October, after studying the issue for more than a year, the Presidential Commission for the Study of Bioethical Issues issued its report on whole genome sequencing. The introduction gets[…]
The capability to remotely monitor, interrogate and reprogram implanted medical devices provides important benefits for patients. It also makes the devices vulnerable to attack, similar[…]
In a warning letter dated September 24, 2012, FDA says the Texas Applied Biomedical Services Research Review Committee (TABS RRC) ”significantly violated…21 CFR Part 56″. The[…]
A study published this week in the Journal of Clinical Oncology suggests that physicians need to work on their presentation of phase 1 trials to parents[…]
The total count of CNS and joint infections related to the multistate fungal meningitis outbreak has risen to 247, with 19 deaths reported (including 8 in Tennessee, the hardest hit[…]