Search Results for drug shortages

Showing 1 – 25  of 52

FDA Allows Temporary Saline Imports to Deal With Shortages Caused by Hurricane Maria By Zachary Brennan - Published 11 October 2017

Baxter Healthcare said in letters to health care professionals dated Monday that it is working with the US Food and Drug Administration (FDA) to import sodium chloride and glucose intravenous infusion products from Ireland and Australia to address shortages because of Hurricane Maria.

Categories: News, US, FDA, Crisis management, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Baxter, drug shortages, Puerto Rico, Hurricane Maria

Canada to Require Drugmakers to Publicly Disclose Drug Shortages By Zachary Brennan - Published 13 March 2017

Beginning on Tuesday, 14 March, amendments to Canada’s Food and Drug Regulations will come into force making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations to two websites, DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca.

Categories: News, Canada, Health Canada, Business and Leadership, Drugs, Ethics, Government affairs

Tags: drug shortages, Food and Drug Regulations

GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern By Michael Mezher - Published 16 February 2017

The US Food and Drug Administration's (FDA) oversight of medical products remains a high-risk area for the federal government, particularly with regard to the agency's oversight of drug shortages, according to a report from the Government Accountability Office (GAO) released Wednesday.

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

Tags: GAO, Government Accountability Office, Drug Shortages

GAO on Drug Shortages: FDA’s Prioritization of Generic Injectable ANDAs is Helping By Zachary Brennan - Published 13 July 2016

As the number of new drug shortages has generally decreased since 2011, the US Government Accountability Office (GAO) said that although it cannot establish a causal link, the US Food and Drug Administration’s (FDA) prioritization of reviewing hundreds of applications and supplements during the time period GAO examined helped address some shortages.

Categories: News, US, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Government affairs, Manufacturing

Tags: drug shortages, drug manufacturing inspections, generic injectables

WHO Offers New Plan to Limit Drug Shortages By Zachary Brennan - Published 29 January 2016

The World Health Organization (WHO) released a new report this week on ways to address global drug shortages, which are increasing in frequency, particularly for old, off-patent or difficult to formulate treatments.

Categories: News, Asia, Europe, US, EC, EMA, FDA, WHO, Biologics and biotechnology, Crisis management, Drugs, Government affairs

Tags: WHO, drug shortages, injectable shortages, cancer drug shortages

European Regulatory Roundup: EMA Looks to Harmonize Definition of Drug Shortage (28 January 2016) By Nick Paul Taylor - Published 28 January 2016

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

Categories: News, Europe, EMA, NICE, Biologics and biotechnology, Clinical, Drugs, Government affairs, Manufacturing

Tags: EMA, drug shortages, NICE, EGA

FDA Finalizes Six-Month Drug Shortage Notice Regulation By Michael Mezher - Published 08 July 2015

A regulation proposed by the US Food and Drug Administration (FDA) in 2013 will take effect on 8 September, requiring drug and biologics manufacturers to notify the agency in advance of impending drug shortages.

Categories: Biologics and biotechnology, Communication, Crisis management, Drugs, Manufacturing, Postmarket surveillance, Product withdrawl and retirement

Tags: Drug shortages, FDASIA

Government Report Slams DEA for Oversight of Drug Production Quota System By Alexander Gaffney, RAC - Published 07 May 2015

Shortages of some pharmaceutical products could be alleviated if the Drug Enforcement Administration (DEA) coordinated its efforts to control the supply of some drugs more closely with the US Food and Drug Administration (FDA), a new government report has found.

Categories: News, US, CDER, Drugs, Manufacturing

Tags: DEA, Drug Shortage, Drug Shortages, APQ, Quota, GAO, GAO Report

FDA Takes its Fight Against Drug Shortages to the App Store By Alexander Gaffney - Published 05 March 2015

Drug shortages have been something of an endemic problem in the US for the last several years. For healthcare providers, it can be difficult to tell when a drug is in stock or experiencing a short- or long-term shortage. Now a new mobile application developed by the US Food and Drug Administration (FDA) is hoping to change that.

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

Tags: Drug shortages, App store

Mirroring International Efforts, Canada Escalates Fight Against Drug Shortages By Michael Mezher - Published 11 February 2015

The Canadian Government will soon release new regulations on drug shortage reporting, it has announced. The regulations will require companies to report drug shortages on a new, independently run website.

Categories: News, Canada, Health Canada, Biologics and biotechnology, Distribution, Drugs, Manufacturing, Product withdrawl and retirement

Tags: Drug Shortages, Drug Shortage

European Industry Group Calls for Drug Shortage Reporting Standards By Michael Mezher - Published 02 February 2015

A group of four pharmaceutical industry associations in Europe is proposing a set of guidelines meant to help European National Competent Authorities (NCAs) and the European Medicines Agency (EMA) alleviate drug shortages through better communication.

Categories: News, Europe, EMA, Communication, Crisis management, Manufacturing, Product withdrawl and retirement

Tags: EFPIA, drug shortages, communication, GMP

Facing Dire Shortage of IV Saline, FDA Again Turns to Enforcement Discretion Approach By Alexander Gaffney, RAC - Published 30 April 2014

Categories: US, FDA

Tags: Shortage of Saline, IV Saline, Saline, Baxter, Enforcement Discretion, Drug Shortage, Latest News, Drug Shortages

Brazil to Require Notice One Year Prior to Drug Withdrawal By Louise Zornoza, RegLink - Published 31 March 2014

Categories: Regulatory Update, Anvisa

Tags: Drug Shortage, Drug Shortages, brazil

GAO Says FDA Doing (Almost) All It Can to Alleviate Drug Shortages By Alexander Gaffney, RAC - Published 11 February 2014

Categories: US, FDA

Tags: Report, Drug Shortage, Latest News, Drug Shortages, GAO

BIO Argues Changes Needed to FDA's Drug Shortage Rule to Account for Vaccines By Alexander Gaffney, RAC - Published 15 January 2014

Categories: US, FDA

Tags: Drug Shortage Rule, Vaccine, BIO, Drug Shortage, Latest News, Drug Shortages

Could FDA's New Drug Shortage Rule Make Shortages Worse? Generic Drug Industry Says 'Yes' By Alexander Gaffney, RAC - Published 07 January 2014

Categories: US, FDA

Tags: GPhA, Reporting, Drug Shortage, Latest News, Drug Shortages, regulation

Reasons for Shortage Unclear, House Members Ask FDA to Consider Importing Alternatives By Alexander Gaffney, RF News Editor - Published 14 November 2013

Categories: US, FDA

Tags: Drug Shortage, Import, Drug Shortages

EMA Launches Drug Shortage Registry as Part of 'Short Term' Action Plan By Alexander Gaffney, RF News Editor - Published 05 November 2013

Categories: EMA

Tags: Drug Shortages, Shortage, EU

Drug Shortage Rule Issued by FDA, Adopting a 'Name and Shame' Approach to Compliance By Alexander Gaffney, RF News Editor - Published 31 October 2013

Categories: US, FDA

Tags: Drug Shortage, Drug Shortages

Stubborn Drug Shortages Lead FDA to Develop Consumer-Focused Mobile App By Alexander Gaffney, RF News Editor - Published 31 October 2013

Categories: US, FDA

Tags: Mobile App, Drug Shortage, Latest News, Drug Shortages

Shortages Ongoing and Import Approach in Legal Jeopardy, FDA Turns to Expedited Approvals By Alexander Gaffney, RF News Editor - Published 07 October 2013

Categories: US, FDA

Tags: Enforcement Discretion, Drug Shortage, Import, Latest News, Drug Shortages

FDA Loses Major Case Testing its Enforcement Discretion Authority By Alexander Gaffney, RF News Editor - Published 23 July 2013

Categories: US, FDA

Tags: Sodium Thiopental, Death Penalty, Drug Shortages, execution

Anvisa Proposes Mandatory Notice for Manufacturing Suspension By Ansis Helmanis, RegLink - Published 28 June 2013

Categories: Regulatory Update, Anvisa

Tags: Drug Shortages, Shortage, pharmaceutical, brazil, drug

Reform Bill Takes Aim at 'Gray Market' Causes for Drug Shortages By Alexander Gaffney, RF News Editor - Published 20 May 2013

Categories: US

Tags: Legislation, Drug Shortage, Drug Shortages, Congress

FDA Seeks Industry Input on Regulatory 'Strategic Plan' to Fight Drug Shortages By Alexander Gaffney, RF News Editor - Published 11 February 2013

Categories: FDA, CDER

Tags: Strategic Plan, FDASIA, Drug Shortage, Latest News, Drug Shortages, pharmaceutical, plan, drug