Expert: ISO 13485 Could Cause Confusion With FDA’s Quality System Regulation
Changes in the new ISO 13485 may conflict with many of the requirements in FDA’s quality system regulation. Source: The GMP Letter
Pentax Issues Revised Reprocessing Instructions for Duodenoscopes
The FDA has signed off on reprocessing instructions for Pentax’s ED-3490TK video duodenoscope that aim to prevent future of infections related to drug-resistant bacteria. Source: The GMP Letter
Amicus Briefs: Don’t Punish Apotex for Complying With BPCIA Rules
Generic and biosimilars manufacturers are coming to the aid of Apotex in its drawn-out patent fight with Amgen, arguing that a district court order effectively punishes the Canadian drugmaker for…
Boehringer Must Turn Over Documents to FTC in Wake of High Court Order
Boehringer Ingelheim has to hand over settlement papers to the FTC after the U.S. Supreme Court rejected the company’s assertion that the documents are protected communications. Source: Generic Line
International Journal of Toxicology
SAN DIEGO, FEBRUARY 17, 2014 – Daily Application of Alprostadil Topical Cream (Vitaros) Does Not Impact Vaginal pH, Flora, or Histology in Female Cynomolgus Monkeys. Click the PDF Icon for…
BTS Research Attends The 2014 ACT
ORLANDO, NOVEMBER 10-11, 2014 – BTS Research attends The 2014 American College of Toxicology 35th Annual Meeting at the Hyatt Regency Grand Cypress.
BTS Research Attends The 2014 AAPS
SAN DIEGO, NOVEMBER 2-6, 2014 – BTS Research attends The 2014 American Association of Pharmaceutical Scientists at the San Diego Convention Center.
BTS Research Attends The 2014 AAPS National Biotechnology Conference
SAN DIEGO, MAY 19-20, 2014 – BTS Research attends The 2014 AAPS National Biotechnology Conference at the Sheraton Hotel and Marina.
BioQuant & BioTox Sciences is Now BTS Research
SAN DIEGO, APRIL 14, 2014 – To better reflect company strengths and direction, BioQuant and BioTox Sciences will now operate under the name BTS Research. Our old names will continue…
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