Search Results for Black box warning

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Researchers Call for Transparency When Black Box Warnings Are Removed By Michael Mezher - Published 24 March 2016

A team of Harvard researchers are calling for the US Food and Drug Administration (FDA) to develop guidelines detailing its decision-making process for removing black box warnings from drug labels.

Categories: News, US, FDA, Drugs, Postmarket surveillance

Tags: Boxed warning, Black box warning, Chantix, Avandia

[Update] FDA: New Postmarketing Study, Black Box Warning for Essure By Zachary Brennan, Michael Mezher - Published 29 February 2016

This article has been updated with more information presented by FDA in a press call Monday and the release of the draft guidance referenced in FDA's announcement.

Categories: News, FDA, Labeling, Medical Devices, Postmarket surveillance

Tags: Essure, Bayer, Essure Problems, Black box warning

State Health Officials Petition FDA for New Warnings on Opioids, Benzodiazepines By Zachary Brennan - Published 22 February 2016

Concerns over the risks of co-prescribing benzodiazepine and opioid drugs has 41 state health officials petitioning the US Food and Drug Administration (FDA) to place a new black box warning on both classes of pharmaceuticals to warn patients and doctors of the potential risks with concomitant use.

Categories: News, US, FDA, Combination products, Crisis management, Drugs, Due Diligence, Labeling, Postmarket surveillance

Tags: opioids, benzodiazepine, black box warning, boxed warning

Researchers Link FDA Actions to Decrease in LABA Use in Asthma Treatment By Michael Mezher - Published 11 January 2016

A recent study finds an association between regulatory actions by the US Food and Drug Administration (FDA) and the use of long-acting β2-agonists (LABA) commonly used to treat asthma.

Categories: News, US, FDA, Communication, Drugs, Medical Devices, Postmarket surveillance

Tags: LABA, Long-acting β2-agonists, Asthma, Serevent Diskus, Salmeterol, Black box warning, Formoterol

Consumer Group Calls for New Warnings for Low-T Products, Delay of Endo's Aveed By Alexander Gaffney, RAC - Published 26 February 2014

Categories: US, FDA

Tags: Boxed Warning, Testosterone, Low-T, Public Citizen, Citizen Petition, Black Box Warning, Latest News

Analysis: OPDP More Likely to Issue Warning Letters if Drug has Black Box Warning By Alexander Gaffney, RF News Editor - Published 14 November 2013

Categories: US, FDA

Tags: OPDP, Untitled Letter, warning letter, APL, Black Box Warning, promotion

43 Attorneys General: New Black Box Warning Needed to Prevent Neonatal Death By Alexander Gaffney, RF News Editor - Published 14 May 2013

Categories: US, FDA

Tags: Margaret Hamburg, Black Box Warning, Hamburg

FDA Restricts Ovarian Adnexal Mass Assessment Score Test System with Black Box Warning By Alexander Gaffney - Published 30 December 2011

Categories: FDA

Tags: APL, Ovarian Adnexal Mass Assessment Score Test System, OAMAST, Class II, Black Box Warning, Latest News