Topic:

Regulatory

Latest Headlines

Latest Headlines

China drug safety improving CFDA says

The China Food and Drug Administration (CFDA) said in a recent report that the country's food and drug safety industry has improved and that cases of illegal or bad drug cases fell in 2015 compared to 2014.

FDA maintains tight grip on Indian and Chinese products

The U.S. Food and Drug Administration rejected more than 13,000 products made in India in the five years between 2010 and 2015, according to FDA data cited in an Economic Times report, and rejected slightly more than 15,000 products made in China.

American pharma group says IP protection in India is weak

The Pharmaceutical Research and Manufacturers of America (PhRMA), one of the top bodies representing American pharmaceutical and biotechnology companies, said in its annual report that India's intellectual property rights protection is weak and the group added India to its "priority watch list."

FDA panel backs Pfizer and Celltrion's Remicade biosimilar over J&J's objections

A group of independent FDA advisers voted in favor of OK'ing Pfizer and Celltrion's take on the blockbuster inflammation treatment Remicade for all of the reference drug's approved indications, unswayed by protests from Johnson & Johnson.

Startup raises $7M, adds execs for FDA-reviewed, antibacterial hospital scrubs

Orlando, FL-based Vestagen Technical Textiles has raised $7 million to back its antibacterial hospital garments that it hopes to get through the FDA. The cash is expected to enable the upstart to get to market with its Vestex antibacterial textile, which it said can reduce harmful contaminants on garments, thereby reducing the spread of pathogens.

FDA nod for LifeWatch wireless, patch-based vital signs monitoring system

Swiss remote diagnostic monitoring company LifeWatch has secured a clearance from the FDA for its wireless, patch-based vital signs monitoring system. It's expected to be used first in medical facilities such as hospitals and nursing homes, but eventually the company expects to target the ambulatory care market as well.

FDA says drug delivery devices need human factors validation testing

Several drug delivery devices are on a draft list of med tech that will be subject to a final guidance calling for the application of human factors and usability engineering to medical devices.

Top Senate Democrat grills HHS about opioid panel's alleged ties to industry

About a third of panelists at a Department of Health and Human Services (HHS) meeting on painkiller prescribing had financial ties to companies that make the drugs, a recent report showed. A top Senate Democrat is not pleased with those findings, and he's grilling the HHS about the members' relationships with the industry.

Japan continues to see generics as way to ease healthcare costs

The government of Japan is changing the lucrative brand-name healthcare market as its population ages and requires more drugs with a push to make at least 80% of the government's drug spending be for generics.

Hospitals, CMS rail against update to FDA device safety reports amid duodenoscope pushback

Last month, senators pointed to problems with duodenoscopes linked to superbug outbreaks and partly blamed an outdated FDA reporting system for not adequately monitoring the devices' safety. The lawmakers want to give the system a facelift, but they could face obstacles from hospitals and Medicare officials who are railing against some of the proposed changes.