Through the Prescription Drug User Fee Act, enacted in 1992 and most recently renewed in 2012, the U.S. Food and Drug Administration can collect user fees from pharmaceutical and biological product manufacturers to help expedite the drug approval process. However,…
Supply Chain
Wilmington, Mass.-based Tecomet, a medical device manufacturer has acquired the equipment manufacturing sector of Warsaw, Ind.-based Symmetry Medical, according to a Boston Business Journal report.
Chattanooga, Tenn.-based TractManager, marketed under the name MediTract, has acquired Dallas-based MD Buyline.
The U.S. Food and Drug Administration has issued draft guidance that would exempt certain medical devices from premarket submission requirements.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.