New guidance on biologics affects authorized generics

USA – GDUFA III: Use MDUFA model to create competition in generic drug markets

As negotiations for the reauthorization of the Generic Drug User Fee Act (GDUFA) continue, stakeholders should consider a new financial model to improve equity...

USA – FDA overdue on guidance as DSCSA deadline looms

Legal experts advised the pharmaceutical industry to start preparing now to meet the November 2023 deadline for having fully electronic interoperable systems in place...
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

USA – Rare diseases, STAR expansion considered in PDUFA VII premarket negotiations

Newly released minutes from meetings between industry and the US Food and Drug Administration (FDA) give observers more insight into premarket review issues in...

USA – FDA: Master protocols have value in COVID-19, and beyond

An official from the US Food and Drug Administration (FDA) recommended that developers of COVID-19 drugs consider using master protocols to assess the benefits...

USA – FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities...

During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities that manufacture FDA-regulated products. These tools include...

USA – NIH trial of anti-CD14 antibody to treat COVID-19 respiratory disease begins

A clinical trial testing the safety and efficacy of an investigational monoclonal antibody for treating people who are hospitalized with respiratory disease and low...

USA – FDA, CDC recommend J&J vaccine pause while rare clots investigated

In a joint statement followed by a Tuesday morning press conference, the US Food and Drug Administration (FDA) and Centers for Disease Control and...

USA – FDA withdraws 5 opioid ANDAs for no REMS or reports

Five generic opioid drugs are being withdrawn from the market by the US Food and Drug Administration (FDA), according to a Federal Register announcement. The action comes...
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) : Guidance

USA – PDUFA VII postmarketing talks focus on REMS, Sentinel

As the US Food and Drug Administration (FDA) and industry worked through FDA commitments for the upcoming reauthorization of the Prescription Drug User Fee...

USA – NIH begins study of allergic reactions to Moderna, Pfizer-BioNTech COVID-19 vaccines

A clinical trial is underway to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for...

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