Search Results for Hamburg

Showing 1 – 25  of 79

Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky' By Zachary Brennan - Published 20 March 2017

As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach."

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

Tags: drug imports, Bernie Sanders, Califf, Hamburg, commissioners on drug imports

Former FDA and NIH Heads Call for Regulatory Harmonization By Zachary Brennan - Published 11 May 2016

Former US Food and Drug Administration (FDA) commissioner Margaret Hamburg and former National Institutes of Health (NIH) director Elias Zerhouni are calling for more global regulatory drug and device harmonization in an editorial posted Wednesday in Science Translational Medicine.

Categories: News, Africa, Asia, Canada, Europe, US, CDSCO, EMA, FDA, GHTF, Health Canada, ICH, IMDRF, MHRA, WHO, Active pharmaceutical ingredients, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: regulatory harmonization, regulatory convergence, Margaret Hamburg, Sanofi

Senators Hint at Confirmation of Califf as Next FDA Commissioner By Zachary Brennan - Published 17 November 2015

Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Clinical, Combination products, Drugs, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Preclinical, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Califf, Senate HELP, FDA commissioner, Senate confirmation hearing, Duke University, Margaret Hamburg, Elizabeth Warren, Bernie Sanders

President Obama Nominates Califf as Next FDA Commissioner By Zachary Brennan - Published 15 September 2015

President Barack Obama has nominated Robert Califf, the current deputy commissioner for medical products and tobacco at the US Food and Drug Administration (FDA), as the next commissioner of the agency.

Categories: News, US, FDA, Combination products, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Robert Califf, FDA, Margaret Hamburg, FDA Commissioner

Former FDA Commissioner Steps Into New, Internationally Focused Healthcare Role By Alexander Gaffney, RAC - Published 07 April 2015

Margaret Hamburg, the former commissioner of the US Food and Drug Administration (FDA), may have stepped down from her role as commissioner earlier this week, but that doesn't mean she's stepping away from government service or healthcare just yet.

Categories: News, US

Tags: Margaret Hamburg, Hamburg, IOM

FDA Commissioner Margaret Hamburg to Resign Next Month By Alexander Gaffney, RAC - Published 05 February 2015

Margaret Hamburg, one of the longest-serving commissioners in US Food and Drug Administration (FDA) history, plans to announce her resignation tomorrow, FDA officials have confirmed to Regulatory Focus.

Categories: News, US, FDA

Tags: Margaret Hamburg, Resign, Resignation, Stephen Ostroff

Charts: Who are the Longest-Serving Commissioners in FDA History? By Alexander Gaffney, RAC - Published 05 February 2015

On 5 February 2015, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg announced she would resign from her position in March 2015. This caused us to wonder: How long will Hamburg have served when she steps down from her position, and how does that compare with other FDA Commissioners before her?

Categories: News, US, FDA

Tags: FDA Commissioners, Commissioner of Food and Drugs, FDA Commissioner, Margaret Hamburg

Legislators Ask FDA to Explain How it Missed Presence of Smallpox Vials for Decades By Alexander Gaffney, RAC - Published 28 July 2014

The recent discovery of vials of smallpox and other potentially deadly pathogens at a facility controlled by the US Food and Drug Administration (FDA) raises "very serious questions" about federal regulators' capabilities and compliance with federal law, legislators said in a letter to FDA Commissioner Margaret Hamburg and other federal officials.

Categories: News, US, CBER, Audit, Compliance, Crisis management

Tags: Smallpox, Variola, Legislators, Letter, Margaret Hamburg, Audit

FDA Officials are Frequent Visitors to White House, Data Show By Alexander Gaffney, RAC - Published 28 April 2014

Categories: US, FDA

Tags: Visit, White House, Margaret Hamburg, Latest News

Global Healthcare Product Regulators in Talks to Form New Regulatory Supergroup By Alexander Gaffney, RAC - Published 12 March 2014

Categories: FDA

Tags: ICMRA, Speech, Latest News, Hamburg

Legislator Says FDA's Plans for Expediting Drug and Device Approvals May Be too Ambitious By Alexander Gaffney, RAC - Published 06 February 2014

Categories: US, FDA

Tags: Margaret Hamburg

As Commissioner Hamburg Plans Official Visit to India, Regulatory Compliance in the Spotlight By Alexander Gaffney, RAC - Published 05 February 2014

Categories: India, US, FDA

Tags: Margaret Hamburg, Latest News, Hamburg

Hamburg Takes Peer-Pressure Approach in Advocating for Safer Compounding Practices By Alexander Gaffney, RAC - Published 10 January 2014

Categories: US, FDA, CDER

Tags: Pharmaceutical Compounding, Compounding Pharmacy, Compounding, Margaret Hamburg

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

As FDASIA Celebrates First Year, FDA Says Drugs, Devices Already Seeing Benefit By Alexander Gaffney, RF News Editor - Published 10 July 2013

Categories: US, FDA

Tags: FDASIA, Margaret Hamburg, MDUFA, Latest News, PDUFA

Republicans Dig Into FDA for Helping to Promote Obamacare Law By Alexander Gaffney, RF News Editor - Published 19 June 2013

Categories: US, FDA

Tags: Letter, Margaret Hamburg, Obamacare, Congress, PPACA

Hamburg: Lab-Developed Tests to be Subject to Heightened Scrutiny under New Framework By Alexander Gaffney, RF News Editor - Published 03 June 2013

Categories: US, FDA

Tags: LDTs, Margaret Hamburg

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

New Funding Required to Allow FDA to Face 'Brave New World' of Global Supply Chains, Says Hamburg By Alexander Gaffney, RF News Editor - Published 18 April 2013

Categories: US, FDA

Tags: Funding, Appropriations Committee, Testimony, Budget, Margaret Hamburg, Latest News, Hamburg, Senate

Hamburg Defends Agency's Response to Compounding Crisis, Floats User Fees as Potential Solution By Alexander Gaffney, RF News Editor - Published 16 April 2013

Categories: US, FDA

Tags: Pharmaceutical Compounding, Compounding, Testimony, User Fees, Margaret Hamburg, Hearing, Latest News, Hamburg

Legislators, FDA Outline Cases in Advance of Major Hearing on Pharmaceutical Compounding By Alexander Gaffney, RF News Editor - Published 15 April 2013

Categories: FDA

Tags: Pharmaceutical Compounding, Compounding, Margaret Hamburg, Hearing, House, Latest News, Hamburg

Hamburg to be Hauled before House Committee again to Address Agency's Compounding Culpability By Alexander Gaffney, RF News Editor - Published 10 April 2013

Categories: US, FDA

Tags: Pharmaceutical Compounding, NECC, Legislators, Compounding, Energy and Commerce Committee, Margaret Hamburg, House, Latest News, Hamburg

BREAKING: Federal Judge Orders FDA to Make 'Plan B' Available Over the Counter to All Ages By Alexander Gaffney, RF News Editor - Published 05 April 2013

Categories: US, FDA

Tags: Kathleen Sebelius, Margaret Hamburg, Sebelius, DHHS, Hamburg

Hamburg: User Fees Might be Solution for Funding Increasing Regulation of Compounding Industry By Alexander Gaffney, RF News Editor - Published 25 March 2013

Categories: US, FDA

Tags: Margaret Hamburg, Hamburg

Hamburg: Compounding, Global Regulatory Issues Top Two Upcoming Areas of Regulatory Focus By Alexander Gaffney, RF News Editor - Published 04 March 2013

Categories: FDA

Tags: Meningitis, Compounding, Globalization, Supply Chain, Latest News, Hamburg, interview, global