1. FDA updates drug product shortages resulting from Hurricane Maria

AHA News Now

Hurricane Maria's impact on drug manufacturing facilities on Puerto Rico has exacerbated the ongoing shortage of amino acids for injections, in addition to other medical supplies, Food and Drug Administration Commissioner Scott Gottlieb, M.D., said yesterday. According to the agency, the... read more

Topic: Access and Coverage
Tag: Drug Shortages

FDA issues update on efforts to address IV fluid shortages

AHA News Now

Food and Drug Administration Commissioner Scott Gottlieb, M.D., today reviewed actions the agency is taking to address the increased shortages of sodium chloride injection bags and other saline intravenous fluids used in hospital and outpatient settings since Hurricane Maria impacted production facilities... read more

Topic: Advocacy and Public Policy
Tag: Drug Shortages

FDA announces shortage drug imports, draft REMS guidance

AHA News Now

Baxter Healthcare Corp. will temporarily import from the United Kingdom certain amino acid drugs in short supply in the United States, beginning with limited quantities in the next few weeks, the Food and Drug Administration announced last week. In other news, FDA last week released draft guidance aimed... read more

Topic: Advocacy and Public Policy
Tag: Drug Shortages

AHA, others call for comprehensive strategy to address critical drug shortages

AHA News Now

Hurricane Maria and other recent natural disasters have heavily compromised pharmaceutical manufacturing in Puerto Rico, leaving the U.S. health care system “on the brink of a significant public health crisis,” the AHA, American Society of Anesthesiologists, American Society of Clinical Oncology, American... read more

Topic: Advocacy and Public Policy
Tag: Drug Shortages

AHA urges FDA to quickly resolve shortages of certain critical drug products

AHA News Now

AHA today urged the Food and Drug Administration to take “any and all steps possible” to resolve worsening shortages of small-volume parenteral solutions that are fundamental to patient care in hospitals. “We are concerned that the shortages of widely-used and critical products are quickly becoming a... read more

Topic: Advocacy and Public Policy
Tag: Drug Shortages

FDA, Baxter issue update on manufacturing recovery in Puerto Rico

AHA News Now

The Food and Drug Administration and Baxter provided an update on efforts Baxter and other companies have taken to reduce the risk of shortages of critically important drugs and to minimize impact on any existing shortages in Puerto Rico after Hurricanes Irma and Maria. In particular, Baxter and the FDA... read more

Topic: Access and Coverage
Tag: Drug Shortages

FDA approves drug imports, CMS certain blanket waivers after hurricanes

AHA News Now

Baxter Healthcare Corp., in coordination with the Food and Drug Administration, has agreed to temporarily import certain intravenous drug products, such as sodium chloride, from the company’s manufacturing facilities in Ireland and Australia to address shortages of critical drug products after Hurricane... read more

Topic: Advocacy and Public Policy
Tags: Drug Shortages, Medicare, disaster readiness

FDA acts to prevent shortages of drugs made in Puerto Rico

AHA News Now

In the wake of Hurricane Maria, the Food and Drug Administration is working to avoid critical shortages of drugs made in Puerto Rico, which is home to dozens of drug and device manufacturing facilities, FDA Commissioner Scott Gottlieb, M.D., announced yesterday. “Since Friday, we have undertaken swift and... read more

Topic: Advocacy and Public Policy
Tags: Drug Shortages, disaster readiness, preparedness

FDA: Hospira recalls emergency syringe drugs due to potential lack of sterility

AHA News Now

Hospira, a Pfizer company, has voluntarily recalled certain lots of 8.4% sodium bicarbonate injection and other emergency syringe drugs distributed since January to hospitals and wholesalers in the United States, including Puerto Rico, because the drugs may not be sterile, the Food and Drug Administration... read more

Topic: Advocacy and Public Policy
Tags: Drug Shortages, emergency care

HHS webinar June 8 on injectable drug shortages, coping strategies

AHA News Now

The Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response will host a June 8 webinar on strategies to address recent shortages of several injectable drugs used in hospitals and other clinical settings, including sodium bicarbonate injection and emergency... read more

Topic: Advocacy and Public Policy
Tag: Drug Shortages

Keyword Search

Date