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- Title
Eyes on New Product Development.
- Authors
Novack, Gary D.
- Abstract
Issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law. Several firms released results of clinical trials covering a wide range of novel therapeutics from anterior to posterior, from re-purposed small molecules to new chemical entities to gene therapies. In this review period, the U.S. Food and Drug Administration (FDA) issued warnings about the marketing of unapproved ophthalmic drugs, including one which was also contaminated.
- Subjects
NEW product development; POSTERIOR segment (Eye); MACULAR degeneration; BUSINESS negotiation; OPHTHALMIC drugs
- Publication
Journal of Ocular Pharmacology & Therapeutics, 2023, Vol 39, Issue 9, p583
- ISSN
1080-7683
- Publication type
Article
- DOI
10.1089/jop.2023.29114.gdn