Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

A March of ducklings on a pathway?? >>>>>>>>>>>>>>>>>>>>

The 505(b)(2) functions essentially as a middle path for drugs that are not entirely new, but are not generic forms of existing drugs, either. Created in 1984 by legislation termed the Hatch-Waxman Amendments, this pathway "is intended to streamline the development and U.S. Food and Drug Administration (FDA) approval of pharmaceutical products that incorporate already-approved pharmacological agents." It allows applicants to provide studies conducted by other entities for other drugs with the same active ingredients, unlike 505(b)(1) applicants, who must provide research conducted specifically for the drug in question. This allows for several benefits, including a decreased risk, given that the active ingredients have already been approved; decreased costs, given that fewer studies need to be conducted; and a potential three, five, or seven year exclusivity period in which the drug will face no competition.

https://askwonder.com/research/fda-s-505-b-2-6xtw0i30s

The Global Asthma and COPD Drugs market is expected to reach $50,359 million by 2022, growing at a CAGR of 3.7% from 2016 to 2022. Asthma is a chronic respiratory disease blocking the airways of lung because of inflammation, mucus production, tighten of muscles. Chronic Obstructive Pulmonary Disease(COPD) is caused by obstruction in the airways causing difficulty in breathing, with the primary cause as tobacco smoking.

https://www.alliedmarketresearch.com/asthma-COPD-drug-market