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Journal Cover   The RPM Report
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   Full-text available via subscription Subscription journal
   ISSN (Online) 2160-4665
   Published by Informa plc Homepage  [14 journals]
  • FDA’s Deadline To Update “Off Label” Policy
    • Abstract: A new provision in the “21st Century Cures” bill would set a deadline for FDA to issue update its policy on off-label information dissemination. That deadline is likely to come in late 2017 – and it probably behooves FDA to act by then regardless of what happens in the Cures legislation.
      PubDate: Thu, 21 May 2015 15:20:03 -040
       
  • FDA-CMS Parallel Review Pilot Will Be Extended; Drugs Not The Focus
    • Abstract: CMS remains open to the idea of using parallel review (or, less formal parallel advice) for prescription drugs, but the current and future focus of the pilot program is likely to stay on devices and diagnostics.
      PubDate: Mon, 18 May 2015 10:55:02 -040
       
  • Precision Medicine Is Precisely Right Theme For Biopharma: Impact Of
           Therapy—Not Cost—Is Focus
    • Abstract: A Senate hearing on President Obama’s Precision Medicine initiative illustrates how while that theme plays for the biopharma sector. The focus was on the potential for highly effective targeted therapies to help patients—and even lower costs for the system.
      PubDate: Fri, 15 May 2015 12:55:04 -040
       
  • CV Outcomes Trials In Diabetes: First Results Suggest
           “Goalpost” Model Here To Stay
    • Abstract: The first FDA advisory committee review of post-marketing cardiovascular outcomes trials conducted under the CV safety requirements imposed by the agency in 2008 ended with clear votes in favor of new warnings for the affected products – and a less explicit but no less clear endorsement of the approach spelled out in the guidelines.
      PubDate: Mon, 11 May 2015 13:45:01 -040
       
  • GDUFA II Negotiations: Let the Saber-Rattling Begin
    • Abstract: The reauthorization of the Generic Drug User Fee Act isn’t going to be as straightforward as the PDUFA process has been for the past two decades. Instead, expect a replay of the first medical device fee renegotiation – with plenty of threats from industry to walk away from the program altogether, likely intended to end up with the best possible deal.
      PubDate: Wed, 06 May 2015 14:45:01 -040
       
  • FDA’s Caretaker: Acting Commissioner Ostroff’s Agenda
           Emphasizes Continuity
    • Abstract: Expect the “Breakthroughs” to keep moving at FDA under acting Commissioner Stephen Ostroff, and for the agency to continue to pay a lot of attention to antibiotics and abuse-deterrent formulations.
      PubDate: Fri, 01 May 2015 10:50:00 -040
       
  • PRO-ving Ground: FDA Review Teams Commit to Patient-Reported Outcomes
    • Abstract: FDA recently announced a significant step in furthering the development of patient-reported outcomes: the planned creation of a web-based compendium of clinical outcomes assessments, including PROs. But an even more significant sign that FDA is committed to developing new patient-reported endpoints came directly from reviewers – including some divisions that have not historically been out front on the issue.
      PubDate: Fri, 01 May 2015 10:25:01 -040
       
  • Get Your Priority Review Voucher, While They Last
    • Abstract: The approval of Retrophin/Asklepion’s Cholbam triggers the third pediatric rare disease priority review voucher – and the sunset provision in the statute authorizing the program.
      PubDate: Sat, 25 Apr 2015 00:00:01 -040
       
  • Six Years Later: FDA’s New Enforcement Paradigm
    • Abstract: FDA’s top compliance official, Howard Sklamberg, used his annual update to the Food & Drug Law Institute to reflect on the changes in FDA’s enforcement structure and authorities during the tenure of Margaret Hamburg, who stepped down after six years as Commissioner of FDA in April.
      PubDate: Fri, 24 Apr 2015 14:25:00 -040
       
  • Medicare “Doc Fix” Enactment: Why Biopharma Companies Should
           Celebrate
    • Abstract: A rare outbreak of bipartisanship in health care legislation led to the enactment of a permanent replacement of the sustainable growth rate payment formula for physicians. The bill doesn’t directly affect biopharma companies – and that is a reason for industry to celebrate.
      PubDate: Fri, 24 Apr 2015 12:00:02 -040
       
  • Comparative Effectiveness Research and the Environment for Health Care
           Decision-Making
    • Abstract: During the last five years, there has beenenormous changes in the health care environment: the implementation of the Affordable Care Act and its many provisions, including the creation of PCORI; the development of health exchanges and a move toward value-based payments, most notably in Medicare programs. In the midst of all this change, what impact will comparative effectiveness research have on health care decision-making?
      PubDate: Fri, 17 Apr 2015 13:45:00 -040
       
  • Complexities of Precision Medicine: Managing Multiple Rx/Dx Combos in the
           Same Class
    • Abstract: What happens when multiple targeted therapies are approved by FDA, each with a unique companion diagnostic for the same biomarker? The health care system is ill-equipped to deal with that scenario, putting patients at risk if the wrong test is used to guide a treatment decision.
      PubDate: Thu, 09 Apr 2015 00:00:00 -040
       
  • 340B Hearing Underscores Era Of Oversight, But Rolling Back Discount
           Program Doesn’t Look Likely
    • Abstract: A House Energy & Commerce/Health Subcommittee hearing on the 340B drug discount program suggests there is bipartisan interest in legislation to enhance oversight of the program – but little interest in steps that might dramatically curtail the availability of discounted drugs to hospitals and other safety net providers.
      PubDate: Wed, 08 Apr 2015 00:00:00 -040
       
  • Dystrophin Disconnect' FDA Workshop Indicates Slow Pace Of Biomarker
           Development
    • Abstract: DMD applications are beginning to arrive at FDA – but the agency is still struggling to get a handle on a proposed biomarker to support their approval. That is a key implication from FDA’s day long workshop on how to measure dystrophin.
      PubDate: Fri, 03 Apr 2015 00:00:04 -040
       
  • Personalized Medicine Meets Payment Policy: MEDCAC Has “Low
           Confidence” In Most Cancer Tests
    • Abstract: Genomic screening of tumor types may be the cutting edge in cancer treatment and a central component of the President’s vision for personalized medicine. But how much evidence is necessary to make insurance coverage for testing routine?
      PubDate: Thu, 02 Apr 2015 12:10:01 -040
       
  • FDA’s Streamlined Review Pilot Takes Flight; Second Oncology sNDA
           Through Process
    • Abstract: FDA’s Office of Hematology & Oncology Products will complete four to five streamlined reviews of supplemental oncology indications before reflecting on the “lessons learned” from the pilot program. After the successful review of Genentech’s Avastin for cervical cancer, FDA says that a second application has gone through the abbreviated process.
      PubDate: Wed, 01 Apr 2015 00:00:01 -040
       
  • Looking Forward At FDA: Hamburg’s Farewell Notes Challenges;
           Califf’s First Remarks Focus on Pediatrics
    • Abstract: FDA Commissioner Margaret Hamburg is leaving the agency on a high note – and taking the opportunity to urge stakeholders to avoid the temptation to push for changes that will “”weaken or undermine” the agency. Meanwhile, FDA's new Deputy Commissioner of Medical Products Robert Califf makes his first formal remarks in that role during a stakeholder meeting on pediatric research.
      PubDate: Tue, 31 Mar 2015 11:55:00 -040
       
  • Reopening The LABA Class: FDA Shepherds Breo Through
           Committee For Asthma
    • Abstract: A “safety focused” advisory committee is never something a sponsor looks forward to. But in the case of FDA’s review of GSK’s new Breo Ellipta asthma inhaler, the outcome was generally positive.
      PubDate: Fri, 27 Mar 2015 00:00:59 -040
       
  • Sitting Out The Patent Dance: Federal Judge Sides With Sandoz In
           Biosimilar Case
    • Abstract: The first biosimilar approved by FDA—Sandoz’ version of Amgen’s filgrastim—is cleared to launch after a federal court judge agreed with Sandoz that the “patent dance” provisions of the biosimilar law are optional, and that a requirement for 180-day notice prior to launch can be given before approval. Here is an excerpt from the ruling, marking the first judicial interpretation of those elements of the statute.
      PubDate: Fri, 27 Mar 2015 00:00:54 -040
       
  • FDA Outlines “Expedited” Review For Breakthrough Therapies;
           “Hyper-Fast” Reviews, Beyond Oncology
    • Abstract: Oncology drug sponsors have gotten used to a “faster-than-Priority” timeline for breakthrough products. Now, FDA is outlining a formal process for its reviewers to use for any “Breakthrough” designated therapy with life-saving potential.
      PubDate: Mon, 23 Mar 2015 11:25:01 -040
       
  • Reality Check For Real World Data: FDA’s Sentinel Network Enters
           “Production” Stage
    • Abstract: FDA’s Sentinel drug safety surveillance network has completed an important transition, moving from “experimental” to “production stage” as a tool to help inform post-market safety decisions. Now the question is whether real-world data can be used in making efficacy decisions.
      PubDate: Mon, 23 Mar 2015 00:00:00 -040
       
  • LIGHT Data Release Raises Heavy Issues for Small Sponsors
    • Abstract: It was supposed to be good news: Orexigen announced a new patent for its weight loss drug Contrave, supported by strong CV safety data from the interim analysis of LIGHT. The controversy that followed underscores how hard it will be for small sponsors to satisfy FDA in the future when it comes to protecting interim data from long term outcomes trials.
      PubDate: Mon, 16 Mar 2015 13:00:00 -040
       
  • FDA Watching For “Unintended Consequences” of 21st Century
           Cures
    • Abstract: Engaging in the House Energy & Commerce Committee’s “21st Century Cures” process and tracking any potential legislation will be a top priority in 2015, FDA’s Janet Woodcock says. Sometimes what seem like good ideas, she says, “have a lot of unintended consequences.”
      PubDate: Mon, 16 Mar 2015 11:30:02 -040
       
  • A Fitting Farewell: Hamburg Earns Praise From Rep. Rogers In Final Approps
           Hearing
    • Abstract: FDA Commissioner Margaret Hamburg and House Appropriations Chair Hal Rogers (R-KY) have had ups and downs over the years, but Rogers praised her and her legacy on prescription abuse.
      PubDate: Mon, 16 Mar 2015 11:00:00 -040
       
  • Direct-Acting Oral Anticoagulant Review Scorecard: Head-to-Head Study
           – of FDA Divisions
    • Abstract: The recent wave of therapies intended to replace warfarin as the gold standard anticoagulant therapy has been an important medical and commercial story for the biopharma sector in the past five years. It also offers an unusual opportunity to compare the approaches taken to reviews by two different divisions within FDA’s Office of New Drugs.
      PubDate: Wed, 11 Mar 2015 13:25:01 -040
       
 
 
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