the role of regulatory affairs personnel is essential to ensure compliance with legislation in all regions in which a company wishes to distribute its drug. Our two interviewees this month discuss ...

In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA ...

The FDA reached a significant milestone when it approved its reorganization and created its new unified Human Foods Program ...

Two words: regulatory ... the FDA published the internal dissension with their approval documents. One of the most vocal objections came from Dr. Ellis Unger, who was director of the Office ...

Regulatory affairs specialists or quality assurance associates can work in the biopharmaceutical or biotechnology industries. In the pharmaceutical world, these professionals manage all the red tape ...

They usually transition after gaining some kind of on-the-job experience in regulatory affairs (e.g., helping to author a new drug application for a compound, or shadowing someone in the regulatory ...

The Food and Drug Administration is ramping up its investigation of the clinical trials that tested an Ecstasy-based therapy, ...

Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of Pharmaceutical Science, the Office of Biotechnology Products (OBP) is currently in ...

“Our team enables Purdue’s pursuit of a culture of compliance and ethical behavior in research by providing comprehensive guidance and support across multiple areas.” —Jamie Mohler, Associate VP for ...

After the FDA declined to approve Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder, companies are pivoting away from or delaying similar therapeutics targeting the ...

There's more bad news for the company behind an experimental MDMA therapy for post-traumatic stress disorder, which the Food and Drug Administration roundly rejected earlier this month. According ...