Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA gets full buy-in for phaseout of antimicrobials

The FDA last year slammed drug companies for marketing antibiotics to production operators and farmers that weren't medically viable for their animals, but had more of a quick-fix function: getting them fat. Urged by the regulator, all of the animal health companies affected have voluntarily engaged with the FDA to help remove 283 of the products in question.

FDA IT modernization push set to continue under 2014-2018 strategic plan

When the FDA laid out its strategic priorities for 2011 to 2015, the agency listed the modernization of its IT infrastructure as a primary objective. Since then, the FDA has seen another chief information officer pass through its revolving doors and faced criticism from the Government Accountability Office, but is still plugging away with the IT modernization agenda in its next strategic plan.

FDA clears first vital sign sensor for chairs

An early step for any hospital patient on the mend is often walking from bed to chair. Physicians have long recognized that walking and sitting upright aids in the healing process but this can be complicated given the various leads and attachments necessary for patient monitoring. Now the FDA has cleared the first sensor to monitor heart rate, respiratory and movement monitors in a chair.

UPDATED: FDA gives an early OK to lymphoma drug Beleodaq

Spectrum Pharmaceuticals has won an early nod from the FDA for belinostat, a new T-cell lymphoma drug that will be sold as Beleodaq.

PBMs join chorus of support for easy names on biosimilar drugs

The FDA is getting an earful from another group intent on saving money on biotech drugs. A coalition of pharmacies, health insurers, unions and pension plans asked the agency to allow biosimilar drugs to carry the same generic names as the drugs they copy. Easy to substitute the biosim for the brand, easier to cut biotech drug spending.

Patent office nomination for J&J top IP lawyer would send anti-reform message

The potential nomination of Johnson & Johnson chief intellectual property counsel Philip Johnson as director of the U.S. Patent and Trademark Office suggests efforts to reform the patent system are dying, especially changes to rein in so called patent trolls.

Device to prevent stray laparoscopic surgical burns clears FDA

Encision won FDA 510(k) clearance for its next-generation active electrode monitoring (AEM) technology for monopolar laparoscopy procedures.

China chooses closed trial for investigator linked to GSK bribery scandal

China's arrest of British private investigator Peter Humphrey and his American wife Yu Yingzeng last summer was a shock to the pharmaceutical community, as Humphrey's firm, ChinaWhys, had long provided assistance to drug companies trying to navigate that country's complicated business environment. Now it looks as if the two are going to be tried privately--in a closed-trial procedure that China normally reserves for cases involving national security or state secrets.

FDA lays out some cGMP guidance for drug compounders

The FDA has published 5 new documents to help compounders understand the agency's expectations for both those that volunteer for oversight and those that don't.

FDA promises a fast review for Boehringer's lung disease contender

The FDA is guaranteeing a priority review for Boehringer Ingelheim's much-watched treatment for a rare lung disease, likely speeding up the drug's path to market as the German pharma races with biotech InterMune.