Drug exclusivity

關於「Drug exclusivity」標籤，搜尋引擎有相關的訊息討論：

Frequently Asked Questions on Patents and Exclusivity | FDA2020年2月5日 · Exclusivity was designed to promote a balance between new drug innovation and greater public access to drugs that result from generic drug ... twCenter for Drug Evaluation, Taiwan2019年11月12日 · Which laws or regulations are related to Pharmaceutical Intellectual Property Protections in Taiwan? · I. There is a 5-year data exclusivity period ... | Biosimilars | Health Affairs2013年10月10日 · A key provision of the BPCIA authorizes the Food and Drug ... drug competition after the end of the brand-name drug's market exclusivity. tw | twTaiwan - Amendment To The Pharmaceutical Affairs Act In Regard ...2018年5月5日 · (b) two-year data exclusivity for the holder of drug approvals of newly added indications or change of indications if the application for such drug is ... | S.250 - 117th Congress (2021-2022): Fairness in Orphan Drug ...2021年2月4日 · This Act may be cited as the “Fairness in Orphan Drug Exclusivity Act”. SEC. 2. Limitations on exclusive approval or licensure of orphan drugs. tw | tw(2021-2022): Fairness in Orphan Drug Exclusivity Act | Congress.govTo amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes. Be it  ...Marketing Exclusivity for Drug Developers: What is it & Different Types2019年8月28日 · Different than patents, Marketing Exclusivity is a key drug development incentive. Understand the types & timelines of different options for your ... twConsidering the Patient in Pediatric Drug Development: How Good ...[14] Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. ... Impact of pediatric exclusivity on drug labeling and demonstrations of efficacy. Pediatrics. 2014 ... [28] Maude SL, Laetsch TW, Buechner J, et al ...Pfizer receives orphan drug status for GL-2045 to treat CIDP2015年8月10日 · In September 2013, Pfizer signed an exclusive worldwide licencing agreement with Gliknik for GL-2045, a drug candidate designed to replace ...Eagle Pharma hits FDA with lawsuit after cancer drug denied orphan ...2016年5月2日 · Bloomberg BNA Eagle Pharmaceuticals Sues FDA Over Marketing Exclusivity Denial offsite link. Follow Ned Pagliarulo on Twitter · post ...