Curtis Rosebraugh Appointed Director of the FDA’s Office of Drug Evaluation II
Curtis (Curt) Rosebraugh, MD, has been appointed as the new director of the US Food and Drug Administration’s (FDA) Office of Drug Evaluation II.
Curtis (Curt) Rosebraugh, MD, has been appointed as the new director of the US Food and Drug Administration’s (FDA) Office of Drug Evaluation II. In 2000, Rosebraugh joined the FDA as a medical officer in the Division of Pulmonary and Allergy Drugs Products. From 2003–2005, he served as the deputy director of the Office of Nonprescription Products and was acting director of the Division of Nonprescription Clinical Evaluation in that office. In 2005, he became deputy director of the Office of Drug Evaluation II and became acting director in September 2007.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Novel Modalities Spur Shift in Outsourcing Processes and Partnerships
May 8th 2025While a one-stop shop still has its advantages, sponsor companies and CDMOs are starting to see each other not as transactional relationships, but true partners with a common goal of getting drugs to patients faster.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
