Supply Chain

The U.S. Food and Drug Administration has issued draft guidance that would exempt certain medical devices from premarket submission requirements.

The number of foreign drug and medical devices the U.S. Food and Drug Administration refuses to import has increased exponentially from 2012 to 2013, according to a news release from Registrar Corp, an FDA consulting firm.

Brentwood, Tenn.-based HealthTrust has offered a purchasing agreement to Salt Lake City-based BioFire Diagnostics, a molecular biology company.

In 2013, venture-backed biopharmaceutical and medical device investments had potentially one of the highest potential returns on investments, according to a report from Silicon Valley Bank, a commercial, international and private bank.

The fees the U.S. Food and Drug Administration charges medical device manufacturers under the Medical Device User Fee program are slated to slightly drop in fiscal year 2015, according to a notice in the Federal Register.

AstraZeneca announced an agreement to pay up to $2.1 billion to purchase Spanish pharmaceutical Almirall's respiratory drug portfolio.

FedEx pleaded not guilty to charges that the company illegally delivered controlled substances and prescription from online pharmacies to U.S. consumers without valid prescriptions, according to a report in The Wall Street Journal.

The drug Sovaldi, manufactured by Foster City, Calif.-based Gilead Sciences, has garnered a lot of attention for its hefty price tag, coming in at $1,000 per pill, or up to $84,000 for a full course of hepatitis C treatment.

In a letter to the editor in Lasers in Surgery and Medicine, Brian Biesman, MD, director of the Nashville (Tenn.) Centre for Laser and Facial Surgery, and Neelam Patel of Vanderbilt University School of Medicine in Nashville, alert physicians to…

The time to market for medical devices can be a lengthy commercialization process, but 3-D printing may help quicken the timeline, according to a Plastics Today report.