Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s

USA – FDA issues guidance on PMA, HDE supplements amid COVID-19

The US Food and Drug Administration (FDA) on Thursday issued an immediately effective guidance allowing medical device makers to make “limited modifications” to their...
New guidance on biologics affects authorized generics

USA – Standalone at-home COVID-19 nasal swab kit receives EUA

A nasal swab kit that allows individuals to collect their own samples for COVID-19 diagnostic testing has been granted an emergency use authorization (EUA)...

USA – FDA updates clinical trial guidance for drugs, devices

The US Food and Drug Administration (FDA) this week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address...

USA – Guidance : Clinical Trial Imaging Endpoint Process Standards

The purpose of this guidance is to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of...

USA – FDA authorizes first antigen test for COVID-19, updates EUA templates

After issuing an emergency use authorization (EUA) for the first antigen test for coronavirus disease (COVID-19) over the weekend, the US Food and Drug...

USA – FDA Authorizes First COVID-19 Test Using Saliva Collected at Home

FDA has given the green light to Rutgers Clinical Genomics Laboratory for its COVID-19 laboratory developed test (LDT), which now offers the option of...

USA – FDA issues EUA for saliva-based COVID-19 test, provides path for wider home...

The US Food and Drug Administration (FDA) on Friday granted the first emergency use authorization (EUA) allowing for at-home saliva sample collection for a...
New guidance on biologics affects authorized generics

USA – FDA abandons proposal for devices referencing drugs

The US Food and Drug Administration (FDA) on Thursday said it will abandon a proposed regulatory approach for medical devices referencing drugs (DRDs) that...
Contact Lenses: CDRH Drafts Guidance on Performance Criteria to Support 510(k)s

USA – CDRH explains notification requirements for device shortages under CARES Act

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday issued immediately effective guidance explaining requirements for medical...
FDA finalizes guidance on clinical, in vitro drug interaction studies

USA – FDA tightens oversight of antibody tests for COVID-19

After initially allowing commercial manufacturers and laboratories to market self-validated antibody tests for coronavirus disease (COVID-19), the US Food and Drug Administration (FDA) says...

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