NIOSH Congregates on Closed System Transfer Device for Hazardous Drugs September 20, 2016 CSTDs are used in the making of cancer-fighting drugs. Read More
Appeals Court Rejects Treble Damage Award in Stryker Lawsuit September 19, 2016 The U.S. Court of Appeals overturned the jury’s “exceptional” finding. Read More
FDA Cites Five Compounding Pharmacies for Risk of Adulteration September 19, 2016 The FDA cited each pharmacy for failing to demonstrate that protective equipment met ISO 5 requirements. Read More
Janssen, Geron to Cut Off Enrollment in Phase II Myelofibrosis Trial September 16, 2016 Janssen said activity in the 4.7 mg/kg arm did not warrant further investigation. Read More
China Revises Device Regulations: What You Need to Know September 16, 2016 Changes will require having a registration agent to be a liaison with the China FDA. Read More
FDA Seeks Comment on Proposed Information Collection for UDI Requirements September 15, 2016 The FDA is requesting comments on the accuracy of its estimate of burden Read More
Unsubstantiated Website Claims Draw FDA Warnings September 15, 2016 Menscience Androceutical sells anti-aging cream through its website. Read More
FDA Raises Cook Recall to Class I September 14, 2016 Cook Medical announced the recall in August. Read More
FDA to Present Guidance on Interchangeability, Analytics for Biosimilars September 14, 2016 The agency will issue recommendations on techniques for evaluating analytical similarity data. Read More
Ovarian Cancer Screens Unreliable, FDA Says September 13, 2016 Women who show no symptoms might delay effective preventive treatments. Read More
Boehringer Inhaler Demonstrates Positive Results in Phase IIIb/IV COPD Trial September 13, 2016 The trial also showed improvements in shortness of breath associated with physical activity. Read More
Failure to Submit Medical Device Reports Leads to 483 for Metrix September 12, 2016 Metrix contacted a hospital customer and instructed them to scrap the bags, but it did not file a report. Read More