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FDA

Latest Headlines

Latest Headlines

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.

Pharmacy groups plead with FDA for more time to get on board with track-and-trace

The Drug Supply Chain Security Act, passed by Congress in 2013, lays out a timetable for companies to be able to comply with the so-called track-and-trace rules that would allow the FDA to more easily locate recalled products and to protect against counterfeits.

Pharmacies want more time to comply with track-and-trace rules

This year the FDA gave drugmakers, wholesalers and logistics companies an extra four months to get on board with new regulations requiring them to be able to track lots of prescription drug products all along the chain of custody. Now pharmacy groups are asking if they could catch a similar break.

FDA slaps U.S. drugmaker over drug testing issues

When a company isn't even familiar with common QC language, it raises red flags for inspectors. Add to that an indication that batch-testing records are riddled with errors and it is a recipe for a warning letter, which is what a South Carolina drug manufacturer has earned from the FDA.