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FDA
FDA: Biosimilars Labeling Guidance
After several delays the FDA has finally released its draft guidance that says a biosimilar's label does not have to be…
Update on Biosimilars US Regulation 1st Quarter 2016
Yesterday the FDA approved Inflectra the Pfizer/Celltrion version of Remicade, becoming the second biosimilar and the…
FDA Announces Labeling Changes for Immediate Release Opioid Medications
The United States Food and Drug Administration has announced new required class-wide safety labeling changes for…
FDA National Direct to Consumer Advertising Survey – Again
If at first you don't succeed try, try again. That seems to be the theme of a recent announcement by the Food and Drug…
PDFUA-MDUFA Update March 2016
Last year, the U.S. Food and Drug administration kicked off the reauthorization process for MDUFA, or the Medical Device…
Amarin and FDA Off Label Free Speech Settlement
The United States Food and Drug Administration (FDA) and Amarin announced that they have reached a proposed settlement…
FDA Draft Guidance: Best Practices for Communication Between IND Sponsors…
To guide investigational new drug application (IND) sponsors' communication with the FDA during development phases, a…
FDA Offering Free Biosimilars CME Course
There is a ballooning interest in biosimilars and interchangeable products in the pharmaceutical industry, especially…
FDA Guidance: Determining the Extent of Safety Data Collection Needed in…
The FDA finalized a guidance it originally released in 2012 that is aimed to help industry collect safety data in…
Robert Califf Confirmed as FDA Commissioner 89-4
Despite months of hand-wringing and opposition, the Senate overwhelmingly voted to confirm Dr. Robert Califf as the next Food and…