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

FDA approves temporary import of sodium bicarbonate injection due to shortage

AHA News Now

The Food and Drug Administration recently authorized the temporary import of a sodium bicarbonate injection product from Australia to address a critical shortage of the drug, commonly used in hospitals to treat a chemical imbalance in the blood. Athenex Pharmaceutical Division will import and distribute... read more

Topic: Advocacy and Public Policy
Tag: Drug Shortages

Study: Septic shock drug shortage associated with higher mortality in 2011

AHA News Now

The U.S. norepinephrine shortage in 2011 was associated with increased mortality among hospital patients with septic shock, according to a study published online yesterday by the Journal of the American Medical Association. The Food and Drug Administration reported a severe nationwide shortage of... read more

Topic: Advocacy and Public Policy
Tag: Drug Shortages

GAO issues update on drug shortages

AHA News Now

The number of new drug shortages has generally decreased since 2011, while the number of ongoing shortages remains high, according to a new report by the Government Accountability Office. The report, mandated by the FDA Safety and Innovation Act of 2012, examines 2010-2015 data on drug shortages from the... read more

Topic: Advocacy and Public Policy
Tags: Drug Shortages, regulation

Study: Acute care drug shortages persist, despite 2012 law

AHA News Now

Early evidence suggests that the Food and Drug Administration Safety and Innovation Act of 2012 has reduced drug shortages overall, but not for acute care drugs, according to a study published today in Health Affairs. “Our estimates, based on reported national drug shortages from 2001 to 2014 collected by... read more

Topic: Advocacy and Public Policy
Tag: Drug Shortages

FDA to allow expedited review of new 'sole-source' generic drugs

AHA News Now

The Food and Drug Administration Friday updated its policies and procedures for review of generic drugs to allow expedited review of applications for new “sole-source” generic drug products. These are drugs for which there is only one approved generic equivalent for a brand-name drug. The House Committee... read more

Topic: Advocacy and Public Policy
Tags: Drug Shortages, drug prices

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