FDA Regulatory Issues and Solutions

FDA Regulatory Issues and Solutions

Jeff Gibbs from Hyman, Phelps & McNamara will be participating in the panel “Optimizing Primary Mode of Action Determination & Process to Appeal FDA Decisions” at Q1’s Combination Product Regulation Conference. See what he has to say on FDA regulatory issues...
Global Combination Products and Human Factors

Global Combination Products and Human Factors

Anoop Padival and Edward Halpern, combination product experts from AbbVie, are taking a deep dive into human factors considerations in the combination product field at Q1’s Combination Product Regulation Conference at the end of February. Padival and Halpern provide a...

ICH Q12 EU Compatibility

The International Council for Harmonization (ICH) works to make global trade in the pharmaceutical industry easier. According to a recent article, the ICH “issued in December of 2017 a draft guidance aimed at more uniformity in rules on the quality of medicines...

FDA Innovative Clinical Trial Designs Launch

FDA Innovative Clinical Trial Designs Launch The U.S. Food and Drug Administration (FDA) is attempting to modernize the drug development process. A new phase of clinical trial designs was recently announced in an effort to help bring new therapies to patients as...