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FDA

Latest Headlines

Latest Headlines

FDA approves a second placement confirmation test for Bayer's controversial Essure birth control device

It may be too little too late. But now the FDA has signed off on the use of transvaginal ultrasound as a means of ensuring the proper placement of the Essure permanent birth control device within three months of its insertion.

Proteus gains first FDA clearance specifically for measuring medication adherence

Proteus Digital Health first won an FDA nod for its ingestible sensor in 2012. But now it's gained an expansion of its label from the agency that indicates that the product can be used in the measurement of medication adherence. That makes it the first and only medical device to have gained this particular indication from the FDA.

GlySure gets CE mark for first continuous intravascular glucose monitor for hospital use

Managing blood glucose levels tightly helps improve morbidity and mortality rates among diabetics. That's particularly true for diabetics who have other major health problems. Now British startup GlySure has gained a CE mark specifically for use in intensive care units with adult cardiac surgery patients. Until now, blood glucose management for these critically ill patients often required frequent manual monitoring by the hospital staff.

The massive med tech IPO: ConforMIS, Glaukos and Natera aim for $100M+

Custom knee implant maker ConforMIS has priced the latest major med tech IPO with its $135 million offering on July 1. Investor appetite for large med tech IPOs raising more than $100 million remains whetted, despite the encroachment of the summer doldrums that can slow Wall Street activity to a crawl.

Purdue pulls out of FDA panel on abuse-deterrent OxyContin just days before meeting

Purdue Pharma has canceled an all-important discussion with FDA advisers about its latest spin on OxyContin less than a week ahead of the scheduled meeting, an uncommon move the company said will ultimately improve its odds of success.

House bill would force FDA to ease up on social media

A Missouri congressman wants to know why the pharma industry is sitting on the sidelines of social media. Actually, Rep. Billy Long (R-MO) has an idea why--and he's proposing legislation to change it. He recently introduced H.R. 2479, which would force the FDA to let pharma share more info about its products online.

Troubled India's Wockhardt sees third U.S. drug recall in as many months

India's Wockhardt has voluntarily recalled 85,000 cartons of over-the-counter heartburn treatment famotidine tablets, calling the state of its plans to recover from U.S. FDA import bans on two plants into further question, Business Line said.

UPenn study finds FDA regulates devices optimally, European regulators are 'too lax'

The FDA is putting increased focus on approving devices faster, as it races to catch up to its European Union counterpart. But University of Pennsylvania researchers were surprised to find that the agency is actually regulating devices appropriately, while European regulators are not.

TCM-based oncology candidate wins U.S. FDA nod for PhIII, Xinhua says

A traditional Chinese medicine (TCM)-based candidate, Kanglaite, won U.S. FDA approval for a multiregion Phase III trial in pancreatic cancer treatment that uses a derivative of the coix seed, the state-run Xinhua news agency reports.

FDA issues guidance to help companies meet their first UDI direct marking deadline

Industry is barreling toward its first direct marking requirement under the FDA's unique device identification (UDI) initiative. To help companies comply with the requirements, the agency released a Q&A-style guidance on the topic.