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 The finalized document follows draft guidance issued on March 28, 2019, filling a requirement of the FDA Reauthorization Act of 2017 (FDARA).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 [...]
adminMTE_04792024-02-26T09:10:23+00:00May 25th, 2020|Categories: Clinical Trial, Compliance, Covid-19, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
The US Food and Drug Administration (FDA) issued a guidance with immediate effect which allows medical device manufacturers to make “limited modifications” to their devices without submitting a premarket approval (PMA), humanitarian device exemption (HDE) supplement or a 30-day [...]
k.janecek2024-02-07T16:16:06+00:00May 18th, 2020|Categories: Clinical Trial, Covid-19, Regulatory, USA|Tags: Clinical Trial, Covid-19, FDA, Regulatory, USA|
FDA issued a guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 emergency. FDA [...]
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