Search
Searching Content indexed under Food, Drugs, Healthcare, Life Sciences by Areta Kupchyk ordered by Published Date Descending.
Links to Result pages
 
1  
 
Title
Country
Organisation
Author
Date
1
Modernization Of The 510(K) Pathway To Market Medical Devices
Congress enacted the Medical Device Amendments in 1976 establishing the regulatory framework for evaluating safety and effectiveness of medical devices.
United States
5 Dec 2018
2
FDA Releases Two Guidances For Innovative Drug Development
On September 28, 2018 the U.S. Food and Drug Administration (FDA or Agency) issued two draft guidance documents focusing on clinical trial designs to advance drug development and competition.
United States
12 Oct 2018
3
FDA Issues Final Guidance On Proprietary Names For Drugs And Biological Products
The Food and Drug Administration (FDA) has finalized guidance for industry describing the agency's evaluation process for proposed proprietary names for drug and biological products.
United States
18 Apr 2016
4
FDA And Amarin Pharma Reach Milestone Settlement Allowing Off-Label Drug Promotion
A milestone Settlement Agreement was reached March 8, 2016 between the Food and Drug Administration and Amarin Pharma, Inc. that expressly allows Amarin to promote its drug product, Vascepa®, for unapproved – i.e., "off-label" – uses.
United States
31 Mar 2016
Links to Result pages
 
1