FDA Related News

FDA Leadership Upheaval Yields Uncertainty: Post

A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.

Medical Devices

FDA Issues Early Alert on Abiomed Impella Introducer Kits

FDA issues an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used with Impella heart pu...

Human Drugs

FDA Bought Unapproved New Drugs on Amazon

FDA warns Amazon it is marketing unapproved new drugs on its Web site.

FDA General

Gottlieb Praises Clinical Trial Initiative; Calls for FDA Career Leadership

Former FDA commissioner Scott Gottlieb supports the agency's newly announced initiative to accelerate early-stage clinical trials, arguing that the p...

Human Drugs

Guide on Using Quantitative Systems Pharmacology Models for Trial Dosing

FDA posts a draft guidance outlining how sponsors can use quantitative systems pharmacology models to determine starting doses for first-in-human clin...

Human Drugs

FDA Revises Guide on Demonstrating Drug Effectiveness

FDA publishes a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new drugs and biologics, ...

Human Drugs

Agency Updates Draft Guidance on Master Protocols

The agency releases a revised draft guidance aimed at helping sponsors design and conduct clinical trials using master protocols, a trial framework in...

FDA General

HHS Unveils Initiative to Accelerate U.S. Clinical Trials

HHS unveils a broad, department-wide initiative aimed at speeding clinical research, reducing regulatory barriers, and attracting more clinical trials...

Human Drugs

Regenxbio Gets FDA Agreement to Refile Gene Therapy BLA

Regenxbio reaches an agreement with FDA on a path toward a potential accelerated approval of Navsunli (clemidsogene lanparvovec-sngl), the first gene ...

Human Drugs

How Global Regulators Handle Cancer Drugs After FDA First Approval: Study

A new journal article finds substantial differences in how major international regulators evaluate and approve oncology drugs that first receive exped...