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Chronological Index of : Politics & Policy

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  • POLITICS & POLICY: FDA to hold patient-focused meeting on psoriasis

    FDA will hold a public meeting March 17, 2016, to discuss psoriasis. The meeting is part of FDA's Patient-Focused Drug Development initiative, in which the agency is holding public meetings to discuss the effects of …

    Published on 11/24/2015
  • POLITICS & POLICY: CFDA implements new drug approval policies

    China FDA said new drug approval policies previously announced by the State Council will go into effect on Dec. 1. The initiatives aim to reduce time to market for new drugs and promote innovation in China, according to…

    Published on 11/23/2015
  • POLITICS & POLICY: GAO report highlights Part B drug costs

    A U.S. Government Accountability Office report released Friday highlights the costs of drugs purchased for patients in Medicare Part B, which covers drugs used in hospitals and out-patient settings such as physicians' …

    Published on 11/23/2015
  • POLITICS & POLICY: Senators propose 'targeted' drug imports

    U.S. Sens. Chuck Grassley (R-Iowa) and John McCain (R-Ariz.) asked HHS Secretary Sylvia Burwell to allow targeted importation of lower cost drugs from Canada to address dramatic drug price increases highlighted in …

    Published on 11/23/2015
  • POLITICS & POLICY: CMS's Slavitt stresses drug price transparency

    CMS Acting Administrator Andy Slavitt told an HHS forum that improved transparency about price and effectiveness is needed to give payers and the public confidence they are receiving value when they purchase drugs. …

    Published on 11/20/2015
  • POLITICS & POLICY: U.S. Treasury unveils rules to curb inversion deals

    The U.S. Treasury Department issued new rules designed to deter and reduce the benefits of corporate inversion deals. Some measures will retroactively apply to inversions completed over the past year.The actions …

    Published on 11/20/2015
  • POLITICS & POLICY: NHS England, NICE unveil CDF proposal

    NHS England and the U.K.'s NICE released a proposal to incorporate the Cancer Drugs Fund (CDF) into the NICE appraisal process starting in April 2016.Under the proposed system, NICE would conduct an initial review of …

    Published on 11/19/2015
  • POLITICS & POLICY: IMS: Drug spending growth to slow in emerging markets

    The IMS Institute for Healthcare Informatics expects drug spending in emerging markets to slow to a compound annual growth rate of 7-10% over the next five years compared to 12% in the last five, according to its annual…

    Published on 11/18/2015
  • POLITICS & POLICY: Reps. urge increased NIH funding

    A bipartisan group of 145 Representatives signed a letter to the House Appropriations Committee requesting annual NIH funding of at least $32 billion, a increase of nearly $2 billion over 2015 levels. The authors cited …

    Published on 11/18/2015
  • POLITICS & POLICY: U.S. Treasury targets inversion deals

    On Wednesday, U.S. Secretary of the Treasury Jacob Lew told members of Congress the Treasury plans to issue guidance this week concerning corporate inversions. In a letter obtained by BioCentury, Lew wrote to the …

    Published on 11/18/2015
  • POLITICS & POLICY: AMA calls for ban on DTC advertising

    The American Medical Association adopted a policy on Tuesday to support a ban on direct-to-consumer advertising for prescription drugs and medical devices. AMA cited physicians' concerns about commercial promotions and …

    Published on 11/17/2015
  • POLITICS & POLICY: FDA, CMS advocate new LDT oversight roles

    In testimony before the House Energy and Commerce Subcommittee on Health, FDA's Jeffrey Shuren and CMS's Patrick Conway made the case for FDA to play a larger role in oversight of laboratory-developed tests (LDTs), …

    Published on 11/17/2015
  • POLITICS & POLICY: Amyloidosis group to submit guidance to FDA

    The Amyloidosis Research Consortium (ARC) plans to submit a draft guidance to FDA by spring 2016 on the clinical development of products to treat amyloidosis, according to President and CEO Isabelle Lousada.She said the…

    Published on 11/16/2015
  • POLITICS & POLICY: Rasi resumes leadership at EMA

    On Monday, Guido Rasi began a five-year term as EMA executive director, a year after his prior appointment to the position was annulled due to a procedural error.Last November, the European Union Civil Service Tribunal …

    Published on 11/16/2015
  • POLITICS & POLICY: Hatch proposes TPP do-over

    The White House rejected a suggestion from Senate Finance Committee Chairman Orrin Hatch (R-Utah) to renegotiate biologics exclusivity provisions in the Trans-Pacific Partnership treaty. Speaking to the U.S. Chamber of …

    Published on 11/9/2015
  • POLITICS & POLICY: HELP committee schedules hearing on Califf nomination

    The Senate Health, Education, Labor and Pensions (HELP) Committee scheduled a hearing on Nov. 17 to consider Robert Califf's nomination for FDA commissioner, according to a committee aide.Last month, committee member …

    Published on 11/6/2015
  • POLITICS & POLICY: China revising drug approval requirements

    China's State Council announced a pilot program that will allow pharmaceutical companies to seek marketing authorizations for new drugs separately from manufacturing licenses. The three-year program will be tested in 10…

    Published on 11/5/2015
  • POLITICS & POLICY: TPP clock now ticking

    The final text of the Trans-Pacific Partnership trade agreement was released Thursday, starting the clock on a 90-day congressional review period. As expected, parties to the treaty would have two options for protecting…

    Published on 11/5/2015
  • POLITICS & POLICY: Amarin free speech settlement delayed

    The conclusion of a landmark off-label promotion lawsuit filed by Amarin Corp. plc (NASDAQ:AMRN) against FDA has been delayed as the parties continue to negotiate settlement terms. Amarin and FDA were scheduled to …

    Published on 10/30/2015
  • POLITICS & POLICY: Budget deal could boost FDA, NIH, hurt 21st Century Cures

    The two-year budget deal passed by the Senate early Friday morning could be good for NIH and FDA, but bad for the 21st Century Cures Act. The deal lifts a cap on non-defense spending by $40 billion above levels that …

    Published on 10/30/2015
  • POLITICS & POLICY: CMS finalizes payment rule for biosimilars

    Rejecting criticism from biosimilars manufacturers, CMS issued a final rule that sets a single reimbursement price for all biosimilars of a given reference product covered under Medicare Part B. The rule will take …

    Published on 10/30/2015
  • POLITICS & POLICY: FTC challenges FDA's biosimilar naming proposal

    The Federal Trade Commission raised concerns over FDA's draft guidance on biosimilar naming, and said attaching different suffixes to non-interchangeable biosimilars and their reference products could lead to reduced …

    Published on 10/30/2015
  • POLITICS & POLICY: NEJM endorses Califf for FDA commissioner

    in-Chief Jeffrey Drazen, the editorial rejected criticisms of Califf's nomination due to his industry …

    Published on 10/29/2015
  • POLITICS & POLICY: Scientists call for microbiome consortium

    An interdisciplinary group of U.S. scientists proposed the creation of the Unified Microbiome Initiative, a consortium to coordinate funding from federal institutions, private foundations and industry to advance …

    Published on 10/28/2015
  • POLITICS & POLICY: Senate Innovations Act seeks to improve FDA hiring

    The Innovations for Healthier Americans Act, a Senate companion to the House 21st Century Cures Act, will include provisions intended to help FDA recruit the "best scientists, personnel, and outside experts," Sen. Lamar…

    Published on 10/27/2015

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