Author: admin

EU: EC Offers New Site Suitability Template under Incoming Clinical Trial Regulation

October 23, 2019
Standards

The European Commission (EC) published a new site suitability template that sponsors of clinical trials can use as part of the application dossier under the EU’s new clinical trial regulation, which...

USA: FDA Drafts Guidance on Patient Engagement in Device Trials

September 27, 2019
Medical Device

The US Food and Drug Administration (FDA) has published draft guidance on how device manufacturers should engage patients when designing medical devices. This Draft Guidance is Intended...

Australia: TGA Implemented the Risk-Based Approach Surrounding Fecal Microbiota Transplants

September 27, 2019
Diagnostics

The Australian Therapeutic Goods Administration (TGA) has adopted a risk-based approach that’s applicable to the Fecal Microbiota Transplants (FMT). The TGA had earlier decided that all the FMT...

China: NMPA Joins IMDRF’s Post-Market Device Safety Data Exchange Scheme

September 27, 2019
Medical Device

The China National Medical Products Administration (NMPA) has joined the International Medical Device Regulators Forum’s (IMDRF) national competent authority report (NCAR) exchange program. NCAR supports...

USA: FDA Confirms the Guidelines in the Development of ALS Drugs

September 27, 2019
OTC

The US Food and Drug Administration (FDA) has finalised guideline to assist sponsors in the clinical development of drugs and biological products for the treatment of amyotrophic lateral sclerosis...

Uncertainty as a Factor in Determining Benefit-Risk for Pre-market Approval of Medical Devices

September 5, 2019
Medical Device

With the recent announcement from FDA’s Center for Devices and Radiological Health (CDRH) about their finalization of guidelines towards accepting a higher premarket uncertainty with regards to the...