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51 Total results for product and free and sample content found

Pink Sheet

Shutdown Bite Tightens At US FDA, But Gene Therapy To Get 50 More Reviewers

By Michael Cipriano 16 Jan 2019

FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.

Topic FDA

Medtech Insight

About Three Months Worth Of Carryover Device Fees Remaining FDAs Gottlieb Says

By David Filmore 16 Jan 2019

US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.

Topic FDA

Scrip

Monumental Year Ahead For Korean Pharmas As New US Approvals Eyed

By Jung Won Shin 16 Jan 2019

2019 could be a monumental year for the South Korean pharma industry, as several new drug assets await the green light from the US FDA.

Topic FDA Business strategies

Medtech Insight

2019 Will Be Testing Period For US FDAs Novel Pre-Cert Paradigm For Digital Health

By Ferdous Al-Faruque 10 Jan 2019

In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.

Topic FDA

Medtech Insight

FDA Device Panel Delivers Thumbs Up For Breakthrough Heart-Failure Device

By Elizabeth Orr 05 Dec 2018

A US FDA panel overwhelmingly supported a heart-failure device designed to use cardiac contractility modulation to improve heart function. The Optimizer Smart system from Impulse Dynamics is apparently the first in FDA’s Breakthrough Devices program to go before an advisory panel.

Topic FDA

Medtech Insight

Philippines Gets Moving On Reg Reform: Asian Medtech Associations Regulatory Networking, October 2018

26 Oct 2018

The Asian Medtech Associations Regulatory Networking discussions this month focus on regulatory reforms in the Philippines, where good progress is being made on embedding a new set of medical device, IVD and labeling regulations. Also, updates from Thailand, Hong Kong and India. This series is hosted by Medtech Insight, along with the Asia Regulatory and Quality Consultancy (ARQon) and the Asia Regulatory Professionals Association (ARPA).

Topic FDA

Medtech Insight

Proposed 510(k) Changes Elicit Some Industry Skepticism

By Elizabeth Orr 18 Oct 2018

Two 510(k) pilots from US FDA indicate the agency's desire for faster, easier clearances. But some observers aren’t sure if they’ll lead to real improvements.

Topic FDA

Medtech Insight

Medtronic Slapped With 2 FDA Warning Letters For Problems At Minnesota, Puerto Rico Sites

By Shawn M. Schmitt 12 Sep 2018

Two Medtronic facilities that make cardiac rhythm management devices were sent warning letters by US FDA because of quality systems issues. The sites were inspected by the agency after the firm initiated high-risk class I recalls for an array of CRM products earlier this year.

Topic FDA

Medtech Insight

'Quik' Review Program Builds On US FDA eSubmission Efforts

By David Filmore 06 Sep 2018

The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.

Topic FDA

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