Regulatory Focus™ > News Articles > Regulatory Recon: Limits Sought on FDA Authority to Regulate Clinical Support Software (25 November

Regulatory Recon: Limits Sought on FDA Authority to Regulate Clinical Support Software (25 November 2014)

Posted 25 November 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Limits Sought on FDA Authority to Regulate Clinical Support Software (25 November 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Bill Aims to Limit FDA Oversight of Clinical Decision Support (Bill-PDF) (EHR Intelligence) (Reuters)
  • Drug Quality and Security Act Turns One (Congress)
  • FDA Advisers Tackle Epidural Steroid Shots (MedPage Today)
  • Getting With The PRO-gram: Making Patient-Reported Outcomes Work (RPM Report-$)
  • FDA posing options for faster antibacterial development (BioCentury)
  • HHS hits Covidien with subpoena over peripheral devices (Mass Device)
  • The US Is Stockpiling Ebola Survivors’ Plasma to Treat Future Patients (Wired)

In Focus: International

  • EMA releases practical guidance on access-to-documents requests (EMA)
  • EU regs for drug-device combinations get more complicated – time for a rewrite? (Clinica-$)
  • Eli Lilly Gets European Approval to Sell Trulicity, a Type 2 Diabetes Drug (NYTimes) (Pharma Times)
  • EU Approves Novartis' Signifor Drug for Rare Hormonal Disorder (Press) (PMLive)
  • EMA hears firms' concerns over new regulatory structures (SCRIP-$)
  • Compulsory Licensing Issues Loom Large Between US, India (The Hindu)
  • Canadian Health Minister mum on apology to thalidomide survivors (Globe and Mail)

US: Pharmaceuticals and Biotechnology

  • Drug Quality and Security Act Turns One (Congress)
  • FDA Advisers Tackle Epidural Steroid Shots (MedPage Today)
  • Getting With The PRO-gram: Making Patient-Reported Outcomes Work (RPM Report-$)
  • Patient-Reported Outcomes in Oncology: The Jakafi and Zytiga Exceptions (RPM Report-$)
  • FDA posing options for faster antibacterial development (BioCentury)
  • What Is The Prescription For Patient Centricity? (Pink Sheet-$)
  • Senators Re-Float to Idea to Allow Personal Import of Prescription Drugs from Canada (NYTimes)
  • What GenVec, Novartis had to do for first trial of gene therapy for hearing loss (BioCentury-$)
  • Could a form of sugar treat deadly Niemann-Pick disease? FDA's Conundrum (CNN)
  • Topamax Taken During Pregnancy Associated With An Increased Risk Of Cleft Lip For Infants Born To Those Mothers (Drug-Injury)
  • Orphan Drug Exclusivity for a Previously Approved Drug: a 505(b)(2) Conundrum (Drug Kennel)
  • Baxter labeling issue could leave patients short on potassium chloride (Fierce)
  • Valeant Pharmaceuticals Announces FDA Approval Of ONEXTON Gel For The Treatment Of Acne Vulgaris (Press)
  • Mylan Confirms First-to-File Patent Challenge Relating to BREVIBLOC (Press)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Janssen Submits New Drug Application for YONDELIS (trabectedin) to U.S. FDA for the Treatment of Patients with Advanced Soft Tissue Sarcoma (Press) (BioCentury)
  • Sprout plans Q1 2015 female sex drug resubmission (SCRIP-$)
  • Bayer drug-device combos gain 'infectious disease' status (SCRIP-$) (MPR) (Press)
  • US FDA pushes back decision date for Novartis’ panobinostat (Pharma Letter-$) (Reuters) (Fierce)
  • Amgen Ends Studies of Gastric Cancer Drug (AP) (Reuters) (Fierce) (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • Roche's Genentech defends supply shift for top cancer drugs (Reuters)
  • More Medicine Goes Off Limits in Drug-Price Showdown (Bloomberg)

US: Medical Devices

  • Bill Aims to Limit FDA Oversight of Clinical Decision Support (Bill-PDF) (EHR Intelligence) (Reuters)
  • HHS hits Covidien with subpoena over peripheral devices (Mass Device)
  • FDA Eyes Regulatory Oversight Of Bolus Calculator Apps (Gray Sheet-$)
  • FDA Clears New Flu, RSV Dx Molecular Test (MPR) (Press)
  • Covidien’s Fortrex PTA Balloon Receives FDA 510(k) Clearance (Press) (Mass Device)
  • Vascular Solutions Receives 510(k) Clearance for Gel-Block(TM) 10x Embolization Product (Press)

US: Assorted And Government

  • 21st Century Cures Bill Coming in January 2015 (E&C)

Upcoming Meetings

Ebola Outbreak

  • The US Is Stockpiling Ebola Survivors’ Plasma to Treat Future Patients (Wired)
  • U.S. Buys Up Ebola Gear, Leaving Little for Africa (WSJ-$)

Europe

  • EMA releases practical guidance on access-to-documents requests (EMA)
  • EU regs for drug-device combinations get more complicated – time for a rewrite? (Clinica-$)
  • Eli Lilly Gets European Approval to Sell Trulicity, a Type 2 Diabetes Drug (NYTimes) (Pharma Times)
  • EU Approves Novartis' Signifor Drug for Rare Hormonal Disorder (Press) (PMLive)
  • EMA hears firms' concerns over new regulatory structures (SCRIP-$)
  • EMA appoints Luc Vanheel as head of administration (PMLive)
  • EMA adopts guidelines on phthalate excipients, cross-contamination in manufacturing (In-Pharma)
  • IQWiG welcomes WHO Statement on Public Disclosure of Clinical Trial Results (Press)
  • Apitope Receives Orphan Designation in the European Union for ATX-F8-117 for the Treatment of Haemophilia A (Press)

India

  • Compulsory Licensing Issues Loom Large Between US, India (The Hindu)
  • India dependent on China for 12 drugs on National List of Essential Medicines: Government (India Times)

Japan

  • Elbit Imaging Ltd. Announces That Insightec Awarded Approval in Japan for Treatment of Pain Palliation Caused by Bone Metastases and for Advanced Treatment of Uterine Fibroids (Press)
  • Soliris (eculizumab) Granted Orphan Drug Designation in Japan for the Treatment of Patients with Neuromyelitis Optica (Press)

Canada

  • Federal Health Minister mum on apology to thalidomide survivors (Globe and Mail)
  • Victims of 1960s Thalidomide Crisis Seek Support from Federal Government (Press)

Clinical Trials

  • AiCure clinical trial seeks to validate video-based medication adherence (MobiHealthNews)
  • Eli Lilly Increasing Patient Access to Clinical Trial Information (Eli Lilly)

General Regulatory And Interesting Articles

  • How 3-D printing is revolutionizing medicine. (New Yorker)
  • Little understood chemicals cut men’s fertility (Reuters)

Regulatory Reconnaissance #448 – 25 November 2014

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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