FDA regulation

Latest Headlines

Latest Headlines

After quiet Q4, device recalls surge in 2012

Recalls of medical devices jumped 160% between the fourth quarter of 2011 and the first quarter of 2012, a not-entirely unexpected development after 2011's late-year tranquility.

FDA device regulator calls for more authority

Without specifically endorsing legislation introduced by House Democrats, the FDA's top dog on medical devices has thrown his support behind tougher regulations for approving products that have...

FDA talks, but doctors don't necessarily listen

Poor FDA. It takes flak every time a drug spawns unexpected side effects. But when it tries to warn doctors about those side effects--and offers advice for preventing them--few physicians are

Congresswoman: Novartis troubles call for more FDA oversight

California Congresswoman Mary Bono Mack said she is perplexed that FDA inspectors continued to cite problems at the Novartis ($NVS) Lincoln, NE, plant without holding the drugmaker accountable. The...

FDA details its actions on shortages

A companion to the HHS report on the economics of drug shortages [see related story] is an FDA analysis of its role in resolving them. President Barack Obama also mentioned this report in the

Woodcock: More predictable manufacturing may ease regulations

Drug manufacturing experts from the 1950s would have no trouble recognizing today's manufacturing processes, according to the FDA's Janet Woodcock. But that will change as batch processing gives way

Senate bill would ease FDA conflict-of-interest rule

As long as they're publicly disclosed and "unavoidable," experts who have conflicts of interest should be allowed to serve on FDA advisory panels. That's the gist of a bill proposed by three U.S.

FDA blames quality issues for most shortages; others blame FDA

The FDA has thrown down an answer to last week's charge that bumped-up oversight--aka over-regulation--is to blame for record-breaking shortages of key drugs. Quality problems at drugmakers are

Report: FDA readies release of long-awaited rules on biosimilars

Despite increasingly loud groans from the payer community in healthcare, the FDA has demonstrated repeatedly that it plans to take its time to craft a regulatory pathway for biosimilars. Its current...

Is the FDA writing a recipe for the failure of biosimilars in the U.S.?

Will FDA officials raise the regulatory bar on biosimilars so high they can't be competitive in the U.S.? Longtime researcher and trial consultant Dr. Saurabh Aggarwal seems to think there's a very