Issue link: http://www.e-digitaleditions.com/i/793410
FDA Guidance addresses botanical products SILVER SPRINGS, MD—The FDA issued "Guidance for Industry: Botanical Drug Development," final- izing its August 2015 draft Guidance on the topic. The document describes the steps to follow in developing botanical products before seeking approval of new drug applications (NDAs) and offers recommendations for submitting investigational NDAs for future botanicals. The Guidance specifies the areas where the Agency plans to apply regulatory policies that differ from those applied to synthetic, semi-synthetic, highly purified, or chemically modified APIs and antibi- otics derived from microorganisms. It also provides general information about the over-the-counter mono- graph system for botanical drugs. ODS publishes strategic plan BETHESDA, MD—The Office of Dietary Supplements (ODS) pub- lished its strategic plan for 2017 to 2021, which lists its goals, strategies, and activities. They include expand- ing the scientific knowledge base of dietary supplements, enhancing the dietary supplement research work- force, fostering the development and dissemination of research resources, and translating research findings into useful information for consumers, health professionals, researchers, and policymakers. IPEC-Americas publishes DMF position paper, joins atypical actives coalition ARLINGTON, VA—IPEC-Americas published a position paper about excipient drug master files (DMFs). The document lists recommendations for the submission and maintenance of DMFs; justification of costs of DMFs and filing alternatives; considerations for inactivating compendial excipient DMFs; thoughts on excipient suppliers sharing more information with their customers; and alternative sources for common information found in most excipient DMFs. It also dispels mis- conceptions about excipient DMFs and provides scenarios in which adopting a new excipient DMF would be beneficial. In other news, IPEC-Americas and other trade organization are forming an atypical actives coalition, which will collaborate with the FDA on man- aging atypical actives within current and future regulations. Its goal is to develop a harmonized definition of atypical actives and propose guidelines for them. Briefly noted… The FDA approved Sunovion Pharmaceuticals' Latuda (lurasidone HCI) capsule for treatment of schiz- ophrenia in patients age 13 to 17. Trulance (plecanatide), a once- daily tablet manufactured by Synergy Pharmaceuticals, was approved by the FDA to treat adults with chronic idiopathic constipation. The FDA approved AbbVie's Imbruvica (ibrutinib), a chemotherapy- free capsule treatment for patients with relapsed refractory marginal zone lym- phoma who failed prior therapies. 8 March 2017 Tablets & Capsules Capsules of Vegetable Origin • Suitable for all types of products • Low moisture content • Ideal for moisture sensitive, hygroscopic and liquid formulations • Resistant to cross-linking • USP/EP compliant dissolution • FDA "GRAS" status • Global regulatory acceptance • Preservative Free • Allergen Free • Kosher and Halal Certified (866) 788-2888 www.capscanada.com info@capscanada.com