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Tag: fda
BIO addresses FDA approval of biosimilar product.
2015-03-10 13:31:09| Industrial Newsroom - All News for Today
BIO issued statement regarding approval by FDA of the first biosimilar product under the pathway created by the Biologics Price Competition and Innovation Act. According to Jim Greenwood, BIO President and CEO, for more than a decade, BIO has called for open, transparent, and science-based dialogue regarding biosimilars. It is unfortunate that the lack of publicly available naming guidance resulted in FDA's assignment of a "placeholder" name for approved biosimilar.
Tags: product
approval
addresses
bio
FDA Adopts 3 Standards focusing on nanotechnology.
2015-03-10 13:31:09| Industrial Newsroom - All News for Today
U.S. FDA adopted 3 nanotechnology standards as part of update to List of Recognized Standards. Adopted standards were ISO/TS 14101, Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method; ASTM E2490, Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS); and ASTM E2535, Standard Guide for Handling Unbound Engineered Nanoscale Particles in Occupational Settings.
Tags: standards
focusing
fda
adopts
Aerocrine Ab Receives Fda Clearance For Niox Vero BlueTooth Wireless Enhancement
2015-03-10 12:15:55| Appliances - Topix.net
Aerocrine AB announces today that clearance was received for its FeNO measuring device to operate wirelessly with BlueTooth technology in the US. The US FDA has granted Aerocrine AB regulatory clearance for NIOX VERO through a special 510k to utilize BlueTooth wireless technology to send FeNO measurements and patient data between the NIOX VERO and the healthcare providers' computers.
Tags: wireless
bluetooth
clearance
receives
FDA involved in case after approving psych meds that cause boys to grow breasts
2015-03-10 07:11:58| Food - Topix.net
It's not often that the FDA gets sued for anything, but a powerful Philadelphia legal firm that handles whistleblower and class action cases throughout the nation, Sheller, P.C., has petitioned the Federal Court to demand the FDA follow through with black box warnings for Johnson & Johnson's drug Risperdal or remove its pediatric approval. The FDA had ignored Sheller's requests to allow the legal firm to release documents held by drug company Johnson & Johnson and its subsidiary Janssen that would prove the necessity of withdrawing the FDA's 2006 approval of Risperdal for pediatric prescriptions or at least demand black box warnings.
Aerocrine AB Receives FDA Clearance For NIOX VERO BlueTooth Wireless Enhancement
2015-03-10 06:34:06| wirelessdesignonline News Articles
Aerocrine AB announces recently that clearance was received for its FeNO measuring device to operate wirelessly with BlueTooth technology in the US.
Tags: wireless
bluetooth
clearance
receives
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