Topic:

Regulatory

Latest Headlines

Latest Headlines

Lawmakers question FDA oversight of mobile medical apps as market booms

As mobile medical apps and devices gain market traction, lawmakers are stepping up with questions about how to best regulate the devices.

Navidea bags expanded FDA nod for Lymphoseek

Navidea Biopharmaceuticals secured the FDA's blessing to market Lymphoseek, its diagnostic aid, for use in head and neck cancer patients.

Novartis submits Bexsero to FDA in race for MenB market

Novartis' Bexsero, approved in 34 countries, was the world's first marketed vaccine to protect against the deadly meningitis B. And now, it's one step closer to becoming the first in the U.S.--that is, if a Pfizer candidate doesn't beat it to the finish line.

FDA finds fault with Chinese API maker

On Tuesday, the FDA posted a warning letter sent last week to Chinese ingredientmaker Tianjin Zhongan Pharmaceutical listing problems with keeping equipment clean and running down problems.

Alere gets FDA clearance for rapid influenza test

Alere's i Influenza A & B test, which the company says is the first and only molecular test to detect and differentiate beween the two types, received FDA clearance on June 16.

FDA's ban on Apotex India plant stems from faked test data

In April, the FDA banned a plant in Bangalore, India, owned by Canadian generics maker Apotex. An FDA warning letter posted today explains why.

Pfizer, Novartis race to market with 'breakthrough' meningitis B vaccines

Both Pfizer and Novartis have picked up the FDA's much-coveted breakthrough-therapy designation for their meningitis B vaccines, and now the rivals have chosen the same day to submit their injections for approval, leaving it up to regulators which will hit the market first.

FDA says Apotex India plant has faked data for years

In April, the FDA banned a plant in Bangalore, India, owned by Canadian generic drugmaker Apotex. A warning letter sent last week and posted today by the FDA says that among other issues, it found that the company had deleted data of failed test results and then reported that the batches had passed.

Merck seeks sanctions against Brown U doc over Vioxx comments

David Egilman, a professor of family medicine at Brown University, was once a federal witness in a lawsuit filed against Merck over the now-long-withdrawn Vioxx. Merck finally closed the books on all the Vioxx suits last summer, but the company is now asking a federal judge to sanction Egilman for leaking info to the Wall Street Journal.

FDA approves Novartis U.S. vaccine plant it is trying to sell

Novartis' $1 billion influenza vaccine manufacturing plant in Holly Springs, NC, has just become the first pandemic-ready site FDA-approved to make cell-culture influenza vaccines. Now it needs to find a buyer for the facility.