Search Results for OMB

Showing 1 – 25  of 34

Senate Democrats to Trump: HHS Cuts Will Impede 'Cures' Implementation By Zachary Brennan - Published 16 May 2017

Eleven Senate democrats sent a letter to President Donald Trump on Tuesday explaining how his proposed cuts in the FY 2018 budget for the Department of Health and Human Services (HHS) will make implementation of the bipartisan 21st Century Cures Act much more difficult.

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

Tags: 21st Century Cures Act, HHS budget, Trump budget cuts, OMB

Release of New FDA Guidance Declines Sharply Following Trump’s Inauguration By Zachary Brennan - Published 11 April 2017

For an agency that has announced its intention to release more than 100 draft guidance documents in 2017, the US Food and Drug Administration (FDA) is off to a slow start following President Donald Trump’s inauguration.

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

Tags: FDA guidance documents, OMB, draft guidance pharmaceuticals

Hiring Freeze at FDA: Upton and DeGette Say it Puts Priorities at Risk By Zachary Brennan - Published 07 February 2017

Hampering the US Food and Drug Administration’s (FDA) ability to hire puts bipartisan priorities at risk, Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) wrote in a letter sent Tuesday to the acting director of the Office of Management and Budget (OMB).

Categories: News, US, FDA, Crisis management, Government affairs

Tags: hiring freeze, FDA employee vacancies, FDA hiring, Upton, DeGette, OMB

‘Two Out, One In’: Trump Signs Executive Order to Repeal Regulations By Zachary Brennan - Published 30 January 2017

President Donald Trump on Monday morning signed an executive order (EO) that would require all government agencies to eliminate two regulations for every new regulation instituted.

Categories: News, US, FDA, Biologics and biotechnology, Business and Leadership, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: OMB, hiring freeze, executive order on regulations, Trump, Trump regulations, EO on regs

FDA Stance on Naming Biosimilars Reportedly Finished, Awaiting Government Approval By Alexander Gaffney, RAC - Published 04 August 2014

Two of the Senate's highest-ranking legislators on healthcare issues are calling on the Department of Health and Human Services to finish its review of a guidance document on the naming of biosimilar products drafted by the US Food and Drug Administration (FDA).

Categories: News, US, CBER, CDER, Biologics and biotechnology, Labeling, Submission and registration

Tags: Biosimilar, Name, Naming, Senate, OMB, OIRA, Draft Guidance, Biosimilar Naming Guidance

Hamburg, FDA Get a New Boss in New HHS Chief Sylvia Burwell By Alexander Gaffney, RAC - Published 06 June 2014

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg—and the agency she runs—will soon have a new boss.

Categories: News, US, FDA

Tags: Sylvia Burwell, Sylvia Matthew Burwell, OMB, DHHS, HHS

What's Holding up FDA's Electronic Drug Labeling Rule? By Alexander Gaffney, RAC - Published 10 February 2014

Categories: US, FDA

Tags: e-Labeling Rule, Electronic Labeling Rule, Electronic Drug Labeling Rule, OMB, Letter, Latest News, Congress

Legislators to OMB: Sequestration of FDA User Fees Wrong, Should be Reversed By Alexander Gaffney, RF News Editor - Published 02 December 2013

Categories: US, FDA

Tags: Legislators, Sequestration, Sequester, BsUFA, OMB, User Fees, Letter, House, MDUFA, Latest News, GDUFA, PDUFA

Was OMB's Lengthy Review of the UDI Rule Worth the Wait? By Alexander Gaffney, RF News Editor - Published 25 October 2013

Categories: US, FDA

Tags: UDI Rule, Unique Device Identification, OIRA, UDI, OMB, Latest News

Federal Agency Says FDA's Benefits Far Outweigh its Costs By Alexander Gaffney, RF News Editor - Published 05 June 2013

Categories: US, FDA

Tags: Cost-Benefit, Cost:Benefit, Draft Report, OMB, Benefit, cost, Latest News

Citing Congressional Gridlock, OMB Delays Release of 2014 Budget Proposal By Alexander Gaffney, RF News Editor - Published 16 January 2013

Categories: FDA

Tags: Zients, Budget, OMB

In Unusual Move, FDA Withdraws OMB Submission to Focus on Changes to Device Program By Alexander Gaffney, RF News Editor - Published 04 January 2013

Categories: FDA

Tags: Federal Register, Withdrawn, Withdrawal, Pre-Submission, OMB, Latest News, submission

Sunshine Act Clears CMS Review, But Final Promulgation Could be Months Off By Alexander Gaffney, RF News Editor - Published 29 November 2012

Tags: Gifts, OIRA, Sunshine Act, OMB, Obamacare, Reporting, Transparency, Latest News, CMS, Grassley, PPACA

Focus on OIRA, Regulator of Regulatory Agencies, as Obama Prepares for Second Term By Alexander Gaffney, RF News Editor - Published 20 November 2012

Categories: FDA

Tags: Confirmation, Steinzor, Leader, Sunstein, OIRA, Director, OMB, Latest News, Obama, head

Restricted Travel, Conference Budgets Could Harm Regulators, Say Critics By Alexander Gaffney, RF News Editor - Published 25 October 2012

Categories: FDA

Tags: Conferences, Travel, Regulatory Capacity, Science, GSA, OMB, Latest News

More than $110 Million in FDA User Fees to be Seized Under Sequestration By Alexander Gaffney - Published 17 September 2012

Categories: FDA

Tags: Cuts, WARN Act, Sequestration Transparency Act, Budget Control Act, Sequester, Budget, OMB, Law, User Fee, Latest News, Obama

FDA Could Soon Have Better Information to Plan for Massive Budget Cuts By Alexander Gaffney - Published 08 August 2012

Categories: FDA

Tags: Cuts, WARN Act, Sequestration Transparency Act, Budget Control Act, Sequester, Budget, OMB, Law, Latest News, Obama

Director of OIRA to Step Down at End of August By Alexander Gaffney - Published 03 August 2012

Tags: Step Down, Resign, Regulatory Review, Sunstein, OIRA, OMB, Latest News, Obama, regulatory

User Fee Bills Would End Unique Device Identifier Stalemate By Alexander Gaffney - Published 05 June 2012

Categories: FDA

Tags: Unique Device Identification, Unique Device Identifier, UDI, OMB, Latest News, medical device

White House Throws Support Behind Senate User Fee Bill By Alexander Gaffney - Published 17 May 2012

Tags: Support, FDARA, FDASIA, OMB, User Fee, MDUFA, Latest News, Senate, Obama, GDUFA, PDUFA

FDA's Travel Budget Could be Cut Dramatically Under New Order By Alexander Gaffney - Published 15 May 2012

Categories: Conference, FDA

Tags: Travel, Zients, GSA, OMB, Latest News

New Bill Would Subject Regulations to Quadrennial Legislative Review By Alexander Gaffney - Published 14 May 2012

Categories: FDA

Tags: Regulatory Reform Act, Recommendations, Sunstein, OIRA, OMB, House, Latest News, Obama, Bill, Congress, regulations, regulatory

Proposed Bill Would Mandate Passage of Device Identifier, Data Collection By Alexander Gaffney - Published 11 May 2012

Categories: FDA

Tags: Unique Device Identifier, Tracking, UDI, Delay, OMB, Legislation, Latest News, medical device

Obama Signs Order Promoting International Regulatory Cooperation By Alexander Gaffney - Published 01 May 2012

Categories: FDA

Tags: Regulatory Harmonization, Sunstein, OIRA, OMB, Executive order, harmonization, Latest News, Obama, regulation, regulatory

Report: FDA Developing UDI Barcode System for Medical Devices By Alexander Gaffney - Published 26 April 2012

Categories: FDA, CDRH

Tags: St. Jude Medical, Medtronic, UDI, UID, OMB, Latest News, Boston scientific, medical device