Phoebe Mounts

Phoebe Mounts

Morgan Lewis

Contact  |  View Bio  |  RSS

Latest Publications

Share:

FDA Releases Details of New Framework for Laboratory Developed Tests Regulation

FDA sends notice to Congress on LDTs. The U.S. Food and Drug Administration (FDA) has notified Congress that it intends to issue draft guidance to propose a risk-based, phased-in framework for oversight of laboratory...more

8/1/2014 - Draft Guidance FDA Laboratory Developed Tests Manufacturers Medical Devices

Medical Device Update: FDA Medical Device Guidances Issued in 2014’s Second Quarter

In recent months, the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) has issued draft and final guidance documents at a relatively fast pace. To assist interested parties, we have...more

7/23/2014 - Draft Guidance FDA Final Guidance Healthcare Manufacturers Marketing Medical Devices Unique Device Identifiers

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

3/25/2014 - Exclusive Dealing Agreements FDA Pharmaceutical Prescription Drugs

3 Results
|
View per page
Page: of 1