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Chronological Index of : Politics & Policy

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  • POLITICS & POLICY: EMA final guidelines for IBS trials

    EMA published final guidelines for irritable bowel syndrome (IBS) revising the recommended co-primary endpoints for placebo-controlled trials. The guidance is in line with July 2013 draft guidance recommending co-…

    Published on 9/26/2014
  • POLITICS & POLICY: EMA piloting patient input in MAA reviews

    EMA announced the start of a pilot program to integrate patient discussion of drug benefit-risk into the assessment of MAAs or into decisions on whether to withdraw or restrict access to approved products.In documents …

    Published on 9/26/2014
  • POLITICS & POLICY: FDA to hold FSIAD meeting

    FDA will hold a public meeting Oct. 27 and a scientific workshop Oct. 28 to discuss Female Sexual Interest/Arousal Disorder (FSIAD), and has asked patients for input on therapies to treat the disorder.FSIAD, the most …

    Published on 9/26/2014
  • POLITICS & POLICY: Judge dismisses FDA cyber monitoring case

    A U.S. District Court judge has dismissed a whistleblower case filed against FDA by six current and former employees who alleged the agency illegally monitored their use of government computers.The plaintiffs alleged …

    Published on 9/25/2014
  • POLITICS & POLICY: NCI launches Exceptional Responders Initiative

    NIH's National Cancer Institute (NCI) launched the Exceptional Responders Initiative to identify molecular features of tumors associated with especially strong patient responses to specific drugs, candidates or drug …

    Published on 9/25/2014
  • POLITICS & POLICY: USP endorses INN suffix for biologics

    The U.S. Pharmacopeial Convention (USP) endorsed a draft World Health Organization (WHO) proposal to create a unique suffix for biologic drugs, including biosimilars.A WHO working group proposed a voluntary scheme to …

    Published on 9/24/2014
  • POLITICS & POLICY: FDA plans REMS studies

    FDA published a draft report, "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)," which outlines four projects aimed at "reducing the burden of implementing" REMS for patients and healthcare…

    Published on 9/23/2014
  • POLITICS & POLICY: OIG calls for federal healthcare coupon safeguards

    HHS's Office of the Inspector General said current safeguards are insufficient to prevent consumers from using coupons to fund drug copayments to federal healthcare programs such as Medicare Part D.In a report, OIG …

    Published on 9/23/2014
  • POLITICS & POLICY: Dems propose increased NIH funding

    Reps. Rosa DeLauro (D-Conn.) and Brian Higgins (D-N.Y.) introduced a bill in the U.S. House of Representatives that would lift the cap on NIH funding due to sequestration.The Accelerating Biomedical Research Act, H.R. …

    Published on 9/22/2014
  • POLITICS & POLICY: FDA meeting on abuse-deterrent opioids

    FDA will hold a public meeting in Silver Spring, Md., on Oct. 30-31 to discuss the development, assessment, and regulation of abuse-deterrent opioid medications. The meeting will focus on scientific and technical issues…

    Published on 9/22/2014
  • POLITICS & POLICY: Stakeholders: ADAPT alone insufficient

    Stakeholders at Friday's meeting of the House Energy and Commerce Committee's Subcommittee on Health agreed that the proposed Antibiotic Development To Advance Patient Treatment (ADAPT) Act is necessary but insufficient…

    Published on 9/19/2014
  • POLITICS & POLICY: White House outlines antibiotic strategy

    The White House announced four actions on Thursday as part of a new national strategy to prevent illness and deaths due to antibiotic resistance.President Obama issued both an executive order and the new National …

    Published on 9/18/2014
  • POLITICS & POLICY: FDA awards C-Path $2.1M

    FDA awarded the first $2.1 million of a potential $10.5 million five-year grant to the not-for-profit Critical Path Institute (Tucson, Ariz.). C-Path creates public-private partnerships to speed up drug development and …

    Published on 9/17/2014
  • POLITICS & POLICY: NICE still mulling changes

    The U.K.'s NICE said it is undecided on how to amend its medicine and technology appraisal methods. Moreover, NICE said any changes to its appraisal methods will not sufficiently address concerns about how the NHS …

    Published on 9/17/2014
  • POLITICS & POLICY: Sipes named director of CDER's Office of Regulatory Policy

    Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, announced in an internal memo that the agency hired Grail Sipes as director of CDER's Office of Regulatory Policy (ORP), effective Sept. 22.…

    Published on 9/15/2014
  • POLITICS & POLICY: 21st Century Cures to hold antibiotic resistance meeting

    The House Energy and Commerce Committee's Subcommittee on Health will hold a hearing Sept. 19 to discuss ways to combat antibiotic resistance and foster new drug development. The event is part of the committee's 21st …

    Published on 9/12/2014
  • POLITICS & POLICY: EMA releases adaptive licensing FAQ

    EMA released a guide addressing frequently asked questions about its adaptive licensing program.The program is designed to potentially allow companies to market new products for limited populations based on promising …

    Published on 9/12/2014
  • POLITICS & POLICY: Gates Foundation commits $50 million for Ebola

    The Bill & Melinda Gates Foundation committed $50 million to support emergency efforts -- including the purchase of essential medical supplies and scale up emergency operations -- to contain the Ebola outbreak in West …

    Published on 9/10/2014
  • POLITICS & POLICY: NICE to seek trial data from EU regulators

    The U.K.'s NICE said it will now request clinical trial data from European regulatory authorities if companies do not provide "all the relevant data" necessary for the agency to evaluate technologies. In an updated …

    Published on 9/10/2014
  • POLITICS & POLICY: Schnedar named director of CDER's Office of Compliance

    Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, announced in an internal memo that the agency hired Cynthia Schnedar as director of CDER's Office of Compliance. Schnedar was deputy inspector …

    Published on 9/10/2014
  • POLITICS & POLICY: FDA challenged on LDT regulation

    Rep. Michael Burgess (R-Texas) challenged FDA's statutory jurisdiction to regulate laboratory developed tests (LDTs) at a hearing of the House Energy and Commerce Subcommittee on Health, and alluded to a longer road …

    Published on 9/9/2014
  • POLITICS & POLICY: FDA releases Purple Book for biosimilar products

    FDA, for the first time, published a list of innovator biologics and licensed biosimilars. The list also makes a provision for future updates to designate a biologic product as interchangeable with its reference product…

    Published on 9/9/2014
  • POLITICS & POLICY: FTC files antitrust suit on Androgel deal

    The U.S. Federal Trade Commission (FTC) filed a suit alleging several drug makers engaged in anticompetitive behavior by striking a deal to delay the availability of generic versions of AndroGel testosterone gel.FTC's …

    Published on 9/9/2014
  • POLITICS & POLICY: ASCO, CCO issue mCRPC guidelines

    The American Society of Clinical Oncology and Cancer Care Ontario published new guidelines to treat metastatic castration-resistant prostate cancer that largely reflect how doctors already manage the disease.The …

    Published on 9/8/2014
  • POLITICS & POLICY: King, colleagues call for population-based BRCA screening

    Mary-Claire King, who discovered the breast cancer 1 early onset (BRCA1) gene locus, co-authored a viewpoint published in the Journal of the American Medical Association on Monday arguing that genetic screening for …

    Published on 9/8/2014

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