News Service

late-breaking news in healthcare

FDA News Briefs for Monday, September 18, 2017

September 18, 2017 News Service

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

FDA Panel Unanimously Endorses New Shingles Vaccine

September 15, 2017 News Service

A Food and Drug Administration (FDA) advisory panel voted unanimously on Wednesday to recommend approval of a novel shingles vaccine.

USPSTF Updates Recommendations for Cervical Cancer Screening

September 14, 2017 News Service

The U.S. Preventive Services Task Force (USPSTF) has posted for public comment a draft recommendation statement and draft evidence review on screening for cervical cancer. Comments may be submitted online now through October 9, 2017.

MiniMed Infusion Sets Recalled Due to Insulin Over-Delivery Risk

September 13, 2017 News Service

Medtronic has initiated a worldwide recall of certain MiniMed infusion sets, due to potential risk of insulin over-delivery. The global, voluntary recall is for older insulin pump infusion sets that featured a vent membrane susceptible to blockage by fluid during the priming process.

EpiPen Maker Failed to Properly Investigate Product Failures

September 12, 2017 News Service

Meridian Medical Technologies, Inc. committed significant violations in good manufacturing practice with the manufacture of EpiPen and EpiPen Jr (epinephrine auto-injectors), according to a warning letter issued by the Food and Drug Administration (FDA).  

FDA News Briefs for Monday, September 11, 2017

September 11, 2017 News Service

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

Three Lots of Activase Recalled: Sterility Cannot be Assured

September 8, 2017 News Service

The Food and Drug Administration (FDA) has alerted hospital professionals that Genentech is voluntarily recalling 3 lots of Activase (alteplase) 100mg vials due to lack of sterility assurance.

FDA Approves First Drug for Pediatric Pulmonary Arterial Hypertension

September 7, 2017 News Service

The Food and Drug Administration (FDA) has expanded indications for Tracleer (bosentan, Actelion) to include use in pediatric patients ages 3 years and older with idiopathic or congenital pulmonary arterial hypertension (PAH). Tracleer is now the first FDA-approved drug for pediatric PAH patients.  

FDA Safety Alerts

September 6, 2017 News Service

The Food and Drug Administration (FDA) issued the following safety communications last week.

FDA News Briefs for Tuesday, September 5, 2017

September 5, 2017 News Service

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