Topic:

Regulatory

Latest Headlines

Latest Headlines

UPDATED: FDA simplifies approval process for innovative devices lacking a predecessor

Truly innovative devices that do not have a substantially equivalent predecessor are automatically lumped into Class III, reserved for high-risk devices, and need a costly clinical trial to gain approval. But not all new products are high risk. To fix this barrier to innovation, FDA created the de novo approval pathway in 1997, enabling applicants to apply for approval as low- or moderate-risk devices. 

Glaxo's ViiV venture adds $5B combo pill to its HIV-fighting armory

GlaxoSmithKline may be suffering from R&D setbacks, generic competition and corruption investigations in a dozen countries, but its HIV-oriented venture ViiV Healthcare is racking up new OKs. Friday, the company scored the FDA's blessing for a combo drug pegged at $5 billion in peak sales.

Rollout of openFDA continues with drug labeling, medtech adverse event APIs

Having committed to a fast rollout of APIs at the start of the summer, the FDA made good on its promise this week by making data on drug labeling available. And the regulator went beyond its initial commitment by releasing an API for medical device adverse events.

FDA approves more innovative med tech, faster in first half

The U.S. Food and Drug Administration has picked up the pace on novel medical device approvals, but this year still may not hit levels seen in 2011 and 2012. During the first six months of 2014, the agency granted 17 premarket approvals, way up from 23 for the entirety of 2013.

GlaxoSmithKline's ViiV wins FDA nod for three-in-one HIV treatment

ViiV Healthcare, the HIV-focused venture majority-owned by GlaxoSmithKline, picked up FDA approval for a single pill that combines three antivirals and promises to challenge a leading treatment from Gilead Sciences.

FDA warns Kentucky drug compounder after sick, dead horses reported

The FDA is coming down on drug compounder Wickliffe Pharmaceuticals for poor compliance to manufacturing practices after receiving a report that two horses died following adverse reactions to drugs produced by the Lexington, KY-based operation.

Answer to mystery of Ranbaxy 'settlement discussions' may be found in Texas

Beleaguered Indian drugmaker Ranbaxy Laboratories set aside about $40 million in its last quarter for "ongoing settlement discussions." Now sources are suggesting the drugmaker's need for the funds: a settlement with the state of Texas.

Pfizer, BMS pad bright Q2 with new FDA nod for Eliquis

Pfizer and Bristol-Myers Squibb's Eliquis has been lagging since launch time, trailing behind predecessors Pradaxa and Xarelto. But lately, the drugmakers' efforts have been paying off when it comes to market share, and a new indication may help keep the ball rolling.

UPDATED: FDA clears first smartphone-based device to detect atrial fibrillation

AliveCor announced Aug. 21 that it has received FDA clearance for an algorithm to detect atrial fibrillation, and next month it plans to incorporate the new ability into its AliveECG app for monitoring the heart.

Cubist nears another big antibiotic approval as M&A rumors simmer

Lexington, MA's Cubist Pharmaceuticals is inching toward its second drug approval of the year, hoping to win European and U.S. clearance for a new anti-infective as analysts wonder whether the company is in line for a Big Pharma takeout.