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

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

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 ...

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 ...

Regulatory Affairs Specialists work to ensure that biotechnology or ... They apply for all necessary approvals and marketing permits from the FDA as well as international regulatory offices, and track ...

The FDA recently announced it appointed Ross Segan as the new Director of the Office of Product Evaluation and Quality (OPEQ) ...

Prescription Drug User Fee Act date, in short, PDUFA date, refers to the date/period by which the FDA is mandated to give its verdict on the regulatory application filed by the sponsor company.

For instance, at a recent presentation to the Society of Quality Assurance 2022 Annual Meeting, the FDA Office of Regulatory Affairs Bioresearch Monitoring Division Director Anne Johnson ...

Following in the footsteps of the other review programs at the US Food and Drug Administration's (FDA) Office of ... for Veterinary Medicine, Office of Regulatory Affairs, Rockville, MD, September ...

The Office of Legal Affairs provides comprehensive legal services to the IAEA Director General, Secretariat, Policy-Making Organs and Member States to ensure that the Agency conducts its activities in ...

“FDA clearance of our disposable insulin ... “Our research and development, medical affairs and regulatory teams identified an unmet need within the diabetes community and shepherded this ...

“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 ...