Regulatory Focus™ > News Articles > Regulatory Recon: Quality Metrics, Robotic Surgery Regulation and Who's to Blame in Anthrax Scandal

Regulatory Recon: Quality Metrics, Robotic Surgery Regulation and Who's to Blame in Anthrax Scandal (29 July 2015)

Posted 29 July 2015 | By Michael Mezher 

Regulatory Recon: Quality Metrics, Robotic Surgery Regulation and Who's to Blame in Anthrax Scandal (29 July 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • ‘Quality Metrics’: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications (FDA) (Draft Guidance) (Focus) (FDA Law Blog)
  • UCB's Phase III lupus failure casts further shadow over field (SCRIP-$)
  • FDA Warns Another Foreign API Maker for Data Integrity Issues (FDANews-$)
  • ChiRhoStim Shortage Resolved (MPR)
  • Pfizer Pulls Plug On Lipitor Switch; Actual Use Studies Miss Objectives (Tan Sheet-$)
  • Progenics' orphan cancer drug picks up the FDA's 'breakthrough' tag (FierceBiotech)
  • Docs Tell FDA to Regulate Robotic Surgery Cautiously in Anticipation of Competitors to da Vinci (FierceMedicalDevices
  • FDA Approves Non-Surgical Temporary Balloon Device to Treat Obesity (Gray Sheet-$) (MedpageToday) (Press) (FDA)
  • U.S. Army lab faulted over lax anthrax procedure (Reuters) (SCRIP-$)
  • Topol: Apple Watch helps colleague’s patient self-diagnose heart condition (MedCityNews)

In Focus: International

  • EMA to Encourage use of Scientific Advice for Post-Authorisation Safety Studies (EMA) (Updated Guidance)
  • European Guidance on IFU for Sterilizing Medical Devices (MassDevice)
  • Calls for civil society members for two EMA committees (EMA)
  • Judge rules pharma has ‘ethical' transparency obligation (Pharmafile)
  • Fallout from India's GVK means $1B lost in drug exports by March 2016 (FiercePharmaAsia) (PharmAsiaNews-$)
  • China plans national serious illness insurance rollout this year (FiercePharmaAsia)
  • Noncommunicable Diseases: A Globalization of Disparity? (PLOS)
  • Trans-Pacific Partnership impasse on data exclusivity for biologics softens (FiercePharmaAsia)
  • Global Regulatory Update: India, China, Japan, South Korea and Brazil (MDDI)

US: Pharmaceuticals and Biotechnology

  • ‘Quality Metrics’: FDA’s plan for a key set of measurements to help ensure manufacturers are producing quality medications (FDA) (Draft Guidance) (Focus) (FDA Law Blog)
  • UCB's Phase III lupus failure casts further shadow over field (SCRIP-$)
  • FDA Warns Another Foreign API Maker for Data Integrity Issues (FDANews-$)
  • Who’s on First? FDA Raises the Specter of 180-Day Exclusivity Eligibility/Forfeiture for Generic RESTASIS and Asks If There’s a Phantom “First Applicant” (FDA Law Blog)
  • ChiRhoStim Shortage Resolved (MPR)

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

  • Pfizer Pulls Plug On Lipitor Switch; Actual Use Studies Miss Objectives (Tan Sheet-$)
  • Progenics' orphan cancer drug picks up the FDA's 'breakthrough' tag (FierceBiotech)
  • Esperion looks to disrupt the PCSK9 race with new cardio data (FierceBiotech)
  • Lenvatinib Granted Breakthrough Therapy for Advanced or Metastatic Renal Cell Carcinoma (MPR)
  • BLA for Novel Hemophilia A Therapy Accepted for Review (MPR)
  • FDA Accepts Grazoprevir/Elbasvir NDA for Chronic HCV (MPR)
  • Skin cancer drug sonidegib approved in United States (PJ Online-$)
  • Sanofi: First LixiLan Phase III Trial Hit Primary Endpoint (Press)
  • Experimental MERS vaccine shows promise in animal studies (Reuters)
  • Highland Announces Initiation of Pivotal Trial of HLD-200 in Pediatric ADHD Patients (Press)
  • Human Study Shows Remedy Pharmaceuticals’ CIRARA is Key to Preventing Brain Swelling in Stroke (Press)
  • Cardax Product Candidates Demonstrate Superior Bioavailability vs. Microalgal Astaxanthin in Monkey Study (Press)
  • New Material Opens up Possibilities for Super-Long-Acting Pills (DD&D)

US: Pharmaceuticals and Biotechnology: General

  • MedWatch Safety Alerts for June 2015 (FDA)
  • US FDA finalizes analytical procedures and methods validation guidance (In-Pharma Technologist)
  • Placebo delivery method affects patient response (MNT)
  • Rx Risks Not Disclosed to Trial Participants (MedpageToday)

US: Medical Devices

  • Docs Tell FDA to Regulate Robotic Surgery Cautiously in Anticipation of Competitors to da Vinci (FierceMedicalDevices
  • FDA Approves Non-Surgical Temporary Balloon Device to Treat Obesity (Gray Sheet-$) (MedpageToday) (Press) (FDA)
  • Study Results Show ARROWg+ard Effective in Reducing Catheter Infections and Costs in Low Risk Population (Press)
  • NICO receives additional FDA clearance for specific brainpath indications for subcortical access to brain tumors, cysts and vascular disease (MNT)
  • Smartphone-Based Device That Reads Medical Diagnostic Tests Quickly and Accurately Created (PhysOrg)
  • FDA OKs Phase II Trial for Kerastem’s Alopecia Treatment (MassDevice)

US: Assorted and Government

  • Senate Committee OK’s extra $40m to FDA but refuses Obama’s $146m plan (In-Pharma Technologist)
  • Expensive hep C meds fueled US drug spending spike (SCRIP-$)
  • U.S. Army lab faulted over lax anthrax procedure (Reuters) (SCRIP-$)
  • Americans report improved health, better healthcare: study (Reuters)

Upcoming Meetings and Events

Europe

  • EMA to Encourage use of Scientific Advice for Post-Authorisation Safety Studies (EMA) (Updated Guidance)
  • EMA Post-Authorisation Procedural Advice for Users of the Centralised Procedure Draft Guideline on the Processing of Renewals in the Centralised Procedure (EMA)
  • EMA Pre-Authorisation Procedural Advice for Users of the Centralised Procedure (Revised)
  • European Guidance on IFU for Sterilizing Medical Devices (MassDevice)
  • Calls for civil society members for two EMA committees (EMA)
  • Judge rules pharma has ‘ethical' transparency obligation (Pharmafile)
  • CHMP adopts positive opinion of Obizur for haemophilia A (European Pharmaceutical Review)
  • Fungal resistance represents a huge healthcare threat, warns ESCMID (European Pharmaceutical Review)
  • NICE recommends three new treatments for hepatitis C in draft guidance (European Pharmaceutical Review)
  • NICE draft guidance restricts use of Daklinza for hepatitis C (PharmaLetter-$)
  • MHRA review concludes alteplase is safe for treating acute ischaemic stroke (PJ Online-$)
  • Bavarian Nordic starts PhII of Prostvac in early-stage cancer (FierceVaccines)

India

  • Fallout from India's GVK means $1B lost in drug exports by March 2016 (FiercePharmaAsia) (PharmAsiaNews-$)
  • Automation necessary to ensure cGMP compliance in pharmaceutical facilities (PharmaBiz)
  • Maharashtra FDA chief Harshadeep Kamble to head top panel on online pharmacies (Economic Times)

China

  • China plans national serious illness insurance rollout this year (FiercePharmaAsia)

Canada

Australia

  • Price Information Code of Practice (TGA)

Ebola Outbreak

  • The Individualised versus the Public Health Approach to Treating Ebola (PLOS)
  • Ebola Virus Disease: Experience and Decision Making for the First Patients outside of Africa (PLOS)

Other International

  • Noncommunicable Diseases: A Globalization of Disparity? (PLOS)
  • Trans-Pacific Partnership impasse on data exclusivity for biologics softens (FiercePharmaAsia)
  • WHO and Gates Foundation agree on ways to strengthen collaboration to improve health in the African Region (PharaAfrica)
  • South Africa’s eHealth plan moves forward with roles for private sector (Clinica-$)
  • Global Regulatory Update: India, China, Japan, South Korea and Brazil (MDDI)

General Health and Interesting Articles

  • We Need a Vaccine Development Fund for ‘Death Valley:’ Mahmoud Explains (Pharmalot)
  • Topol: Apple Watch helps colleague’s patient self-diagnose heart condition (MedCityNews)

Regulatory Reconnaissance #606– 29 July 2015

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 @Michael_Mezher 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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe