Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency FDA has issued a Guidance for Industry entitled “Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency.” This guidance provides recommendations on statistical considerations to address the impact of COVID-19 on meeting trial objectives for clinical trials conducted during the duration of the COVID-19 public health emergency.
Trial Master File (TMF): Good Practices and TMF SOPs The TMF is required for firms who are subject to 2001/20/EC Article 15(5) in EU and should be helpful for those who are subject to 21 CFR Part 312 in the US. What is a Trial Master File (TMF)? A TMF is the collection of documentation that allows the conduct of
Ovarian Cancer | PARP Inhibitors Cancer that forms in tissues of the ovary (one of a pair of female reproductive glands in which the ova, or eggs, are formed). Most ovarian cancers are either ovarian epithelial carcinomas (cancer that begins in the cells on the surface of the ovary) or malignant germ cell tumors (cancer that begins in egg cells).
FDA In Vitro Diagnostic Medical Devices and Clinical Trials By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 28, 2014 In Vitro Diagnostic Devices with Clinical Trial Data The following IVD 510(k)s have been cleared by FDA with clinical trial data since January 1, 2013. Device Name Applicant 510(k) No. Decision Date Sofia(R) Rsv Fia Quidel Corp.
FDA Guidance Information Sheet Guidance For Sponsors, Clinical Investigators, and IRBs Waiver of IRB Requirements for Drug and Biological Product Studies This guidance is for drug and biological product studies. January 2006; Updated on October 2017 INTRODUCTION This guidance is intended to provide information for sponsors and sponsor-investigators about requesting a waiver of Institutional Review Board (IRB) requirements for drug and
European Union (EU) Clinical Trials for Medicines: FAQs Clinical Trial Facilitation Group FAQs EudraLex – Volume 10 Clinical trials guidelines Access link to the guidelines at http://regulatorydoctor.com/wp-content/uploads/2013/10/EudraLex-Volume-10-Clinical-trials-guidelines.pdf Clinical trials are investigations in humans intended to discover or verify the effects of one or more investigational medicinal products (“IMPs”). Requirements for the conduct of clinical trials in the EU are provided for
By Regulatory Doctor; LinkedIn; Google Plus; Twitter The following shows the list of 177 510(k)s cleared with clinical trials since 2009. Pursuant to 21 CFR § 807.92(a)(3), a 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket
FDA Guidance for Industry on Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring This guidance assists sponsors of clinical investigations in developing risk-based monitoring strategies and plans for investigational studies of medical products, including human drug and biological products, medical devices, and combinations thereof. The overarching goal of this guidance is to enhance human subject protection and the
From the monster’s mouth: has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) Incretin mimetics have been called “the darlings of diabetes treatment” and they may soon also be licensed for treating obesity. But a BMJ investigation has found growing safety concerns linked to the drugs’ mechanism of action. Deborah Cohen