Search Results for Hospira

Showing 1 – 17

FDA Extends Use Dates for Pfizer Injectables to Ease Shortage By Michael Mezher - Published 16 June 2017

The US Food and Drug Administration (FDA) on Thursday said it is extending the use dates of multiple lots of injectable drugs made by Pfizer subsidiary Hospira by six months to a year in response to an ongoing shortage of the drugs.

Categories: News, US, FDA, Distribution, Drugs, Manufacturing

Tags: Pfizer, Hospira, Shortage

FDA Panel Backs Hospira's Epogen Biosimilar in 14-1 Vote By Michael Mezher - Published 25 May 2017

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday voted 14-to-1 in support of approving Pfizer subsidiary Hospira's proposed biosimilar to Amgen's anemia drug Epogen (epoetin alfa) for all four of its indications.

Categories: News, US, FDA, Biologics and biotechnology, Submission and registration

Tags: Epoetin alfa, Epogen, Hospira, Pfizer, Amgen, Biosimilar

FDA Warns Pfizer’s Kansas Site Following Cardboard Found in Sterile Injectables By Zachary Brennan - Published 28 February 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to Pfizer subsidiary Hospira’s Kansas-based site, finding that the company’s investigations into complaints of visible particulates in sterile injectables were inadequate.

Categories: News, US, FDA, Crisis management, Drugs, Manufacturing

Tags: Pfizer, Hospira, Copaxone, Teva, warning letter

European Regulatory Roundup: ENVI Calls to for EMA Budget Reserves in Case of Brexit Volatility (9 February 2017) By Nick Paul Taylor - Published 09 February 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs

Tags: European regulatory roundup, Brexit, ENVI, aripiprazole, Hospira

Federal Circuit: Use of a CMO Prior to Filing Drug Patents Does Not Invalidate the Patents By Zachary Brennan - Published 11 July 2016

Pharmaceutical and biotech companies will likely be relieved to hear that the use of a contract manufacturing organization (CMO) cannot cause a drug’s patents to be invalidated under what’s known as the “on sale” bar, according to an opinion released Monday from the US Court of Appeals for the Federal Circuit.

Categories: News, US, Active pharmaceutical ingredients, Drugs, Manufacturing, Project management

Tags: Hospira, Medicines Company, on-sale bar, Federal Circuit

NIST Kicks Off Wireless Infusion Pump Cybersecurity Project By Michael Mezher - Published 25 January 2016

The National Institute of Standards and Technology (NIST) is launching a project to improve the cybersecurity of wireless infusion pumps.

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, NIST, National Cybersecurity Center of Excellence, NCCoE, Infusion Pumps, Hospira

Updated: Pfizer Receives FDA Untitled Letter Over YouTube Video By Zachary Brennan - Published 20 January 2016

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Pfizer subsidiary Hospira over the company's "misleading" YouTube video on its sedative Precedex. [Editor's note: This story was updated on 21 January with a Pfizer statement on the video.]

Categories: News, US, FDA, Advertising and Promotion, Crisis management, Drugs

Tags: Pfizer, Precedex, Hospira, untitled letters, OPDP

FDA Form 483s From India: A Deep Dive Into the Problems By Zachary Brennan - Published 09 November 2015

A Focus review (thanks to the Freedom of Information Act) of 50 Form 483s issued by the US Food and Drug Administration (FDA) to Indian pharmaceutical and active pharmaceutical ingredient (API) manufacturers over the past two years reveals a slew of detailed quality concerns from the agency.

Categories: News, India, US, CDSCO, FDA, Active pharmaceutical ingredients, Audit, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Quality

Tags: India, Form 483s, Wockhardt, Glenmark, Hospira, CDSCO, warning letters

Security Researcher Says Additional Hospira Infusion Pumps Vulnerable to Hacking By Alexander Gaffney, RAC - Published 09 June 2015

A prominent security researcher is warning that additional infusion pump models manufactured by Hospira are vulnerable to intrusion by hackers, just weeks after a similar warning prompted action by the US Food and Drug Administration (FDA) and the US Department of Homeland Security (DHS).

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance

Tags: Cybersecurity, Billy Rios, Hacking, Vulnerabilities, Hospira

FDA Issues Stern Warning Letter to Hospira Over Manufacturing Lapses in Italy By Alexander Gaffney, RAC - Published 07 April 2015

The US Food and Drug Administration (FDA) has just issued biopharmaceutical manufacturer Hospira a new Warning Letter—the company's seventh in the last seven years—regarding alleged deficiencies found at the company's Liscate, Italy manufacturing facility.

Categories: News, US, CDER, Compliance, Drugs, Manufacturing, Quality

Tags: Warning Letter, Hospira, Data Integrity

Problems at Hospira's Rocky Mount Facility Continue as FDA Issues Second Warning Letter By Alexander Gaffney, RAC - Published 08 April 2014

Categories: US, FDA

Tags: Rocky Mount, Hospira, warning letter, Latest News

FDA's Battles Over Generic Drug Labeling Continue on a Smaller Scale By Alexander Gaffney, RAC - Published 28 January 2014

Categories: US, FDA, Labeling

Tags: Generic Drug, Hospira, Generic, Latest News, Generics

Recalls by Hospira Continue to Mount as Company Finds Hair, Glass, Steel and Brass By Alexander Gaffney, RF News Editor - Published 03 October 2013

Categories: US

Tags: Hospira, Recall

Human Hair Found in IV Solution Prompts Hospira Recall By Alexander Gaffney, RF News Editor - Published 03 September 2013

Categories: US, FDA

Tags: Hospira, Recall

Edwards, Hospira Warn Investors of Receipt of FDA Warning Letters By Alexander Gaffney, RF News Editor - Published 30 May 2013

Categories: US, FDA

Tags: Hospira, warning letter

Hospira Initiates Class I Recall for Touchscreen, Software Issues By Alexander Gaffney, RF News Editor - Published 30 October 2012

Tags: Class I Recall, Hospira, Recall, Latest News, medical device

Infusion Pump Maker Warned About Alarm Problems Published 30 August 2012

Categories: FDA

Tags: alarm, infusion pumps, Hospira, warning letter, Latest News, devices