{"product_id":"innovations-in-pharmaceutical-manufacturing-on-national-academies-of-sciences-engineeri-9780309088671","title":"Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations","description":"\u003cp\u003eIn 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, flexible pharmaceutical manufacturing sector. The goal was to encourage a transition to manufacturing processes and approaches that could produce high-quality drugs reliably without extensive regulatory oversight. Much progress has been made toward that goal as the industry has developed and advanced new technologies, but more progress is required as recent natural disasters and the coronavirus pandemic have revealed vulnerabilities in supply chains and highlighted the need to modernize pharmaceutical manufacturing further.\u003c\/p\u003e \u003cp\u003eAt the request of the FDA Center for Drug Evaluation and Research (CDER), \u003ci\u003eInnovations in Pharmaceutical Manufacturing on the Horizon\u003c\/i\u003e identifies emerging technologies - such as product technologies, manufacturing processes, control and testing strategies, and platform technologies - that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by CDER. This report describes many innovations to modernize the manufacture of drug substances and drug products, to advance new control approaches, and to develop integrated, flexible, and distributed manufacturing networks within 5-10 years.\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e National Academies of Sciences Engineeri, Division on Earth and Life Studies, Board on Chemical Sciences and Technolog\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0309088674\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780309088671\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e National Academies Press\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 05\/08\/2021\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 120\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.80lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 10.94h x 8.35w x 0.39d","brand":"National Academies of Sciences Engineeri","offers":[{"title":"Paperback","offer_id":44202014638335,"sku":"9780309088671","price":65.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_f49d4c0d-6890-42ab-a4d7-c3cf1b10c7bd.jpg?v=1691492734","url":"https:\/\/www.whiterainbookhouse.com\/products\/innovations-in-pharmaceutical-manufacturing-on-national-academies-of-sciences-engineeri-9780309088671","provider":"WR Book House","version":"1.0","type":"link"}