FDA to beef up cell and gene therapy staff

USA – FDA to beef up cell and gene therapy staff

Citing the 800 active INDs for cell therapy and gene therapy candidates and the expectation that it will be receiving more that 200 INDs...
Bipartisan Bill would allow Drug Imports from Canada

Canada – Bipartisan Bill would allow Drug Imports from Canada

Sens. Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) introduced legislation Wednesday that seeks to allow importation of drugs from approved pharmacies in Canada. The bill, called the...
FDA to beef up cell and gene therapy staff

USA – Gottlieb describes Innovation Office, Biosimilars Policies at JPM

FDA Commissioner Scott Gottlieb described plans to create a new office dedicated to advancing innovation in drug development, and telegraphed upcoming initiatives aimed at...
CDER Outlines Drug Safety Priorities

USA – CDER Outlines Drug Safety Priorities

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) on Tuesday released a new report on drug safety priorities...
Drug Sponsors Urge FDA to Think Bigger About Master Protocols

USA – Drug Sponsors Urge FDA to Think Bigger About Master Protocols

Leading drugmakers are urging the FDA to think bigger about its master protocol guidelines for clinical trials and expand beyond cancer trials. In September, the...
FDA updates endpoint guidance for cancer trials

USA – FDA updates endpoint guidance for cancer trials

Cancer trials that rely on event-free survival and complete response to treatment as surrogate endpoints will be acceptable to FDA reviewers, the agency said...
FDA to Test PreCert De Novo Requests Under Pilot

USA – FDA helps to lead fight against antimicrobial resistance

Scientists and public health officials around the world are working to counter the threats posed by increasingly hard-to-treat, drug-resistant bacteria. In the U.S., the...
Aorta Tears With Certain Antibiotic Use, FDA Warns

USA – Aorta Tears With Certain Antibiotic Use, FDA Warns

Fluoroquinolone antibiotics can, in some patients, increase the occurrence of rare but serious ruptures or tears in the main artery of the body, called...
FDA updates endpoint guidance for cancer trials

USA – FDA Revises Guidance on Oncology Endpoints

Replacing a guidance from 2007, this latest guidance from the US Food and Drug Administration (FDA) clarifies how certain oncology endpoints can serve different...
Warren Seeks to Create Government-Run Generic Drug Manufacturer

USA – Warren Seeks to Create Government-Run Generic Drug Manufacturer

Sen. Elizabeth Warren (D-MA) and Rep. Jan Schakowsky (D-IL) introduced identical bills in the Senate and House on Tuesday that would create an Office...

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