Experts Pitch FDA on Policies to Improve Drug Development

USA – Experts Pitch FDA on Policies to Improve Drug Development

The US Food and Drug Administration (FDA) on Thursday heard from more than two dozen stakeholders on opportunities for the agency to promote more...
Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff : Draft Guidance

USA – Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA...

Executive Summary This document, Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff, sets forth risk-based principles by which the Food...
FDA has little authority to control quality of foreign-made APIs

USA – FDA has little authority to control quality of foreign-made APIs

Following major recalls of Chinese-manufactured medication that contained carcinogenic ingredients, Congress is taking a hard look at the U.S. supply chain of generic drugs. About...
Trump Nominates Hahn to be FDA Commissioner

USA – Trump Nominates Hahn to be FDA Commissioner

President Donald Trump on Friday nominated Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next US...
Experts Pitch FDA on Policies to Improve Drug Development

USA – Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry...

The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of chronic hepatitis D virus (HDV)...
Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff : Draft Guidance

USA – Assessing User Fees Under the Generic Drug User Fee Amendments of 2017...

This guidance provides stakeholders information regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA Reauthorization...
Experts Pitch FDA on Policies to Improve Drug Development

USA – Drug Shortages: Root Causes and Potential Solutions

Drug Shortages: Root Causes and Potential Solutions examines the underlying factors responsible for drug shortages and recommends enduring solutions. The inter-agency Drug Shortage Task Force,...
Determining the Clinical Benefit of Treatment Beyond Progression with Immune Checkpoint Inhibitors

USA – Determining the Clinical Benefit of Treatment Beyond Progression with Immune Checkpoint Inhibitors

In 2018, James Allison and Tasuku Honjo won the Nobel Prize in Physiology or Medicine for their work leading to the development of immune...
Supporting Drug Development Through Physiologically Based Pharmacokinetic Modeling

USA – Supporting Drug Development Through Physiologically Based Pharmacokinetic Modeling

The 16th-century Swiss physician and philosopher Paracelsus once said, “All things are poison, and nothing is without poison. The dosage makes it either a...
Experts Pitch FDA on Policies to Improve Drug Development

USA – Transitioning a Powerful Analytical Tool into Manufacturing to Improve the Quality of...

Mass spectrometry (MS) is a powerful analytical tool used in nearly all protein-based biologics license applications as a characterization method to assess a wide...

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