Search Results for Shortage

Showing 1 – 25  of 42

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

Asia Regulatory Roundup: India Asks China to Expedite GMP Inspection to Resolve a Drug Shortage (14 February 2016) By Nick Paul Taylor - Published 14 February 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: Asia Regulatory Roundup, drug shortage, GMP inspection, India online portal

FDA Staff Shortages May Get Worse With Trump’s Federal Hiring Freeze By Zachary Brennan - Published 25 January 2017

On Monday, President Donald Trump signed an executive order to freeze all federal government hiring and with the US Food and Drug Administration (FDA) lacking almost 1,000 employees, the freeze could further slow new drug, medical device and generic drug approvals.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Due Diligence, Government affairs

Tags: hiring freeze, Trump, FDA staff shortage

Sanofi Halts Production of Bladder Cancer Drug as Others Fail to Win FDA Approval By Zachary Brennan - Published 18 November 2016

Sanofi Pasteur said it’s discontinuing the manufacture of TheraCys, an important bladder cancer drug, and shortages are expected, while the US Food and Drug Administration (FDA) on Friday released draft guidance to help develop new treatments for BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC).

Categories: News, US, FDA, Compliance, Crisis management, Drugs, Government affairs, Quality, Regulatory strategy

Tags: bladder cancer, NMIBC, Sanofi, drug shortage

European Regulatory Roundup: Ireland to Offer Regulatory Advice via New Innovation Office (17 November 2016) By Nick Paul Taylor - Published 17 November 2016

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

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: HPRA, OMCL, drug shortage, CHMP

Asia Regulatory Roundup: CFDA Looks to Resolve Vaccine Shortages (12 July 2016) By Nick Paul Taylor - Published 12 July 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, Biologics and biotechnology, Government affairs, Postmarket surveillance, Quality

Tags: vaccine shortage, Botox, Indian neurology

Updated: EMA Warns of Possible Chemotherapy Shortage in Four Countries Due to Sanofi Manufacturing Snafu By Zachary Brennan - Published 10 June 2016

Fifteen batches of Sanofi’s chemotherapy Taxotere (docetaxel) have been recalled due to a problem in the manufacturing process that could have led to vials being too concentrated, the European Medicines Agency (EMA) said in an updated alert on the possible shortage on Thursday.

Categories: News, Europe, EC, EMA, MHRA, Drugs, Government affairs, Manufacturing, Postmarket surveillance, Quality, Regulatory intelligence

Tags: Sanofi, docetaxel, drug shortage, drug manufacturing

FDA Allows Banned Chinese Firm to Ship Chemotherapy to US as Shortage Threat Looms By Zachary Brennan - Published 18 February 2016

The US Food and Drug Administration (FDA) on Thursday said it will allow the import of a chemotherapy’s active pharmaceutical ingredient (API) from China’s Zhejiang Hisun Pharmaceutical Co. because of concerns of a shortage.

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

Tags: chemotherapy shortage, import alert, Daunorubicin HCl

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

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

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

Legislator Asks for FDA Evaluation of Several Novel Ideas to Solve Drug Shortage Crisis By Alexander Gaffney, RF News Editor - Published 27 September 2013

Categories: US, FDA

Tags: Margaret Hamburg, Drug Shortage

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

Cancer Drug Returns, and with it FDA's Willingness to Go After its Manufacturer By Alexander Gaffney, RF News Editor - Published 07 June 2013

Categories: US, FDA

Tags: Doxirubicin, Untitled Letter, Janssen, Doxil, Misbranded, Shortages, Drug Shortage, Latest News, Shortage, marketing

FDA to Once Again Allow Import of Unapproved Drugs to Solve Shortages By Alexander Gaffney, RF News Editor - Published 29 May 2013

Categories: US, FDA

Tags: Shortage

Sandoz Announces Recall Due to Particulate Contamination, Citing Familiar Problems By Alexander Gaffney, RF News Editor - Published 21 May 2013

Categories: US, FDA

Tags: Sandoz, Methotrexate, Drug Shortage, Recall