Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Hannah Daniel

Reporter

Hannah joined Medtech Insight from HBW Insight in August 2022 and reports on cybersecurity, patent law and other facets of medical device regulation. Hannah is passionate about the intersection of science and communication and holds a bachelor’s degree in biology from Carnegie Mellon University.

Latest From Hannah Daniel

DOJ Files Preliminary Injunction Against Neoprene Manufacturer

The US Department of Justice filed an injunction to limit chloroprene emissions from Denka Performance Elastomer, a facility that makes device components as well as other neoprene products.

Legal Issues Regulation

Industry Supports Transparency On Proposed CMS Prior Authorization Rule

Industry trade groups applaud CMS’s proposal to increase transparency for prior authorization approvals but are asking for expedited timeframes to provide care.

Policy Reimbursement

News We’re Watching – FDA Mammography Update, SVB Collapse, Zoll's Data Breach, And More

News we are keeping an eye on this week includes the FDA’s first traditional market authorization for a COVID-19 test and its approval of a new neurological diagnostic. The agency also updated its device shortage list and revised mammography guidelines.

FDA Policy

Expert: When It Comes To Personal Information, Digital Health Companies Need To Think Broadly

Hogan Lovells partner Scott Loughlin spoke to Medtech Insight about data privacy for digital health companies in the wake of the FTC’s proposed $7.8m settlement with BetterHelp.

Digital Health Enforcement

Increase Access To MedTech: AdvaMed’s Priorities For The 118th Congress

AdvaMed’s Medical Innovation Agenda for the 118th Congress emphasizes increased access to medical devices, from reimbursement for breakthrough devices to boosting America’s start-ups to closing the care disparities for underserved communities.

Policy Reimbursement

FDA FY 2024 Budget Includes 10% Funding Boost, But No Movement On Diagnostics

The FDA requested a 10% increase in budget authority for FY 2024, but diagnostic reform was left out of the proposal. 

FDA Policy
See All
UsernamePublicRestriction

Register