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 Dr. Osterberg joins the consultants at Aclairo®, bringing his many years of academic and preclinical regulatory experience, and allowing Aclairo® to offer more expertise in preclinical regulatory drug development than ever before. Previously, Dr. Osterberg held numerous positions in CDER at FDA. His leadership positions in FDA included supervisory/team leader activities in the Divisions of Anti-Infective; Special Pathogen; and Anti-Inflammatory, Analgesic, and Ophthalmic Drug Products. Dr. Osterberg also held acting positions as the Associate Director of Pharm/Tox for CDER, and began his career in CDER as Deputy Director in the Anti-Viral Division. Dr. Osterberg also has experience in the Centers across FDA, including Veterinary Medicine, Foods, and experience in the US Consumer Product Safety Commission.
He assisted in the development of acute, subchronic, and chronic toxicology testing protocols for the Interagency Regulatory Liaison Group (IRLG), OECD and the Bureau of Foods' Red Book.
Dr. Osterberg has extensive experience with anti-infective, ophthalmological, topical dermal and systemic pharmaceuticals, including antibiotics, anti-fungal, and anti-parasitic drug products. He continues to be one of the central figures in expanding the pharmaceutical industry's understanding of FDA/CDER guidances, preclinical testing, and pharm/tox policies.
Dr. Osterberg was the safety coordinator for FDA/CDER to the ICH process and was either a topic leader or expert working group member for most of the ICH Safety guidances and for the Q3A, B and C guidances |
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