adminMTE_04792024-02-29T16:53:39+00:00July 13th, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The Food and Drug Administration (FDA) announced the plan to resume on-site domestic inspections beginning the week of 20 July 2020. The resume process will be different in each state according to local rules and epidemiological situation. Moreovoer, a [...]
k.janecek2024-02-29T14:46:51+00:00July 1st, 2020|Categories: Compliance, Covid-19, Regulatory, USA|Tags: Covid-19, FDA, Regulatory|
The US Food and Drug Administration (FDA) has published final guidance for unique device identification compliance dates for Class I and Unclassified Medical Devices. This immediately in effect guidance also clarifies the Agency policy concerning compliance dates for certain [...]
k.janecek2024-02-29T17:02:19+00:00June 29th, 2020|Categories: Clinical Trial, Compliance, Regulatory, USA|Tags: Clinical Trial, FDA, Regulatory, USA|
The Food and Drug Administration (FDA) issued guidance on inspections of medical device establishments. The finalized document follows draft guidance issued on March 28, 2019, filling a requirement of the FDA Reauthorization Act of 2017 (FDARA). The guidance specifies [...]
adminMTE_04792024-02-29T17:05:07+00:00June 24th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
FDA published a Q&A document to respond frequently asked questions from submitters and applicants on regulatory matters and issues relating to medical devices arising from the COVID-19 public health emergency. This guidance addresses the following: Meetings with Industry MDUFA [...]
adminMTE_04792024-02-26T09:26:25+00:00June 18th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The FDA issued guidance to provide sponsors with statistical advice in order to maintain trial integrity and reduce the impact of the COVID-19 emergency on clinical trials conduct. This new document follows the agency’s guidances on the conduct of [...]
adminMTE_04792024-02-29T17:13:19+00:00June 9th, 2020|Categories: Covid-19, Regulatory, USA|Tags: Covid-19, Digital Health, FDA, USA|
FDA issued "guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the [...]
k.janecek2024-02-29T17:18:32+00:00June 5th, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, USA|
The US Food and Drug Administration (FDA) updates its guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency. The Agency added information about electronic signatures for informed consent and provided clarification about remote assessments during [...]
adminMTE_04792024-02-26T10:55:19+00:00June 2nd, 2020|Categories: Clinical Trial, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA|
The U.S. Food and Drug Administration is making its previously developed FDA MyStudies app available to investigators as a free platform to obtain informed consent securely from patients for eligible clinical trials when face-to-face contact is not possible or [...]
adminMTE_04792024-02-26T09:34:50+00:00May 28th, 2020|Categories: Compliance, Regulatory, USA|Tags: Covid-19, FDA, USA|
FDA released recommendations for sponsors of decontamination and bioburden reduction systems about what information should be included in a pre-Emergency Use Authorization (pre-EUA) and/or EUA request to help facilitate FDA’s efficient review of such request. Decontamination and bioburden reduction [...]
adminMTE_04792024-02-07T16:13:06+00:00May 25th, 2020|Categories: Covid-19, Regulatory, USA|Tags: Covid-19, FDA, Regulatory, USA|
The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) published a guidance describing how medical device manufacturers should notify CDRH of shortages during the COVID-19 emergency. This is a new reporting requirement for medical [...]
Become part of Meditrial! Subscribe to our newsletter.
Meditrial Europe - VAT CHE-115.033.718 © 2009 - 2024 | All Rights Reserved | Privacy | Terms of Use | Advertising Policy
