News Service

late-breaking news in healthcare

FDA News Briefs for Monday, January 22, 2018

January 22, 2018 News Service

These Food and Drug Administration (FDA) developments came in late last week.

FDA News Briefs for Thursday, January 18, 2018

January 18, 2018 News Service

These Food and Drug Administration (FDA) developments came in this week.

FDA Safety Alerts for Tuesday January 16, 2018

January 16, 2018 News Service

These Food and Drug Administration (FDA) Safety Alerts were recently issued.

FDA News Briefs for Monday, January 15, 2018

January 15, 2018 News Service

These Food and Drug Administration (FDA) developments came in late last week.

FDA Announces Recall of Mislabeled Clopidogrel Tablets

January 12, 2018 News Service

The Food and Drug Administration (FDA) announced on Wednesday that International Laboratories, LLC is voluntarily recalling 1 lot of the platelet inhibitor clopidogrel due to mislabeling.

FDA Will Allow Marketing of IlluminOss Bone Stabilization System

January 11, 2018 News Service

On January 9, 2018, IlluminOss Medical announced that it had received permission from the Food and Drug Administration (FDA) to market the IlluminOss Photodynamic Bone Stabilization System for the treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease, in skeletally mature patients. The FDA granted permission to market the device in late December 2017, via the agency’s de novo classification pathway.

USPSTF Issues Final Recommendation on Screening for Idiopathic Scoliosis

January 10, 2018 News Service

The U.S. Preventive Services Task Force (USPSTF) has released a final recommendation statement and evidence summary on screening for idiopathic scoliosis in children and adolescents 10 to 18 years of age. The Task Force concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for adolescent idiopathic scoliosis in this population. This is a grade I recommendation.  

FDA Advisory Committee Set to Discuss Applications for Modified Risk Tobacco Product

January 9, 2018 News Service

The Food and Drug Administration’s Tobacco Products Scientific Advisory Committee will meet on January 24th and 25th to discuss modified risk tobacco product (MRTP) applications filed by Philip Morris Products S.A. for an electronic system that heats rather than burns tobacco products.

FDA News Briefs for Monday, January 8, 2018

January 8, 2018 News Service

These Food and Drug Administration (FDA) developments came in late last week.

FDA Warns Company Marketing Unapproved Stem Cell Product

January 5, 2018 News Service

The Food and Drug Administration (FDA) has sent a warning letter to American CryoStem Corporation (Monmouth Junction, New Jersey) for marketing Atcell, an adipose derived stem cell product, without the agency’s approval. The letter also warns of significant deviations from current good manufacturing practice requirements, including some that may put patients at serious risk.