Regulatory Focus™ > News Articles > Regulatory Reconnaissance (4 September 2013)

Regulatory Reconnaissance (4 September 2013)

Posted 04 September 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

In Focus: US

  • FDA Publishes List of GDUFA Facilities in User Fee Arrears (FDA)
  • AdComm Members Press FDA to Ease CV Rules for Diabetes Drugs (BioCentury)
  • DEA Scheduling Delays Prompt Calls For Possible Reforms, Including At FDA (IHP)
  • Compounding: FDA Stepping Up Enforcement With Warning Letters? (Pink Sheet)
  • QbD Pilot: "Healthy Interaction" Between FDA and EMA, Says Consultant (In-Pharma)
  • FDA States Keywords Do Not Have To Be Reported on Form 2253s (CHC)
  • Medical foods guidance could open avenues for dietary supplement disease claims, attorney asserts (Nutra Ingredients)

In Focus: International

  • NICE challenges pharma over development costs (Pharma Times)
  • Industry and drug regulators disagree on which data should remain confidential, including adverse event data (BMJ)
  • New Bill with separate chapter seeks to end 'identity crisis' for medical devices (PharmaBiz)
  • Indian Industry Calls for Withdrawal of DCGI Directive on State Licensing Authority-Approved Fixed Dose Combinations (PharmaBiz)
  • Demand for reforms in Chinese pharma grows loud (BioSpectrum)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA Publishes List of GDUFA Facilities in User Fee Arrears (FDA)
  • AdComm Members Press FDA to Ease CV Rules for Diabetes Drugs (BioCentury)
  • DEA Scheduling Delays Prompt Calls For Possible Reforms, Including At FDA (IHP)
  • Simultaneous Applications Submitted to EMA and FDA for Siltuximab for the Treatment of Multicentric Castleman Disease, a Rare Blood Disorder (Janssen) (Pharma Letter) (SCRIP) (BioCentury) (Pharma Times)
  • Compounding: FDA Stepping Up Enforcement With Warning Letters? (Pink Sheet)
  • QbD Pilot: "Healthy Interaction" Between FDA and EMA, Says Consultant (In-Pharma)
  • Industry Seconds Need For Rare Disease Mention In Expedited Approval Guide (IHP)
  • Alameda County Drug Take-Back and Disposal Ordinance Not Unconstitutional Says Federal Judge (FDA Law Blog) (Pharmalot)
  • FDA States Keywords Do Not Have To Be Reported on Form 2253s (CHC)
  • Daiichi Sankyo to cut liver cancer drug dose for ArQule on safety concerns (Reuters) (SCRIP)
  • FDA Warning Letter to Company Cites Extralabel Use of a Veterinary Drug (FDA)
  • LabStyle Innovations Names Shoshana Friedman Vice President of Clinical and Regulatory Affairs (LabStyle)
  • CSL Behring Announces FDA Approval of a 10 g (50 mL) Vial Size for Hizentra (CSLB)
  • Teva's Nuvigil Label-Expansion Effort Shows No Signs Of Fatigue Even After Bipolar Depression Failure (Pink Sheet)
  • Resverlogix rises 40% on new RVX-208 analysis (SCRIP)
  • Rockwell Medical surges on more promising PhIII data for iron-delivery drug (Fierce)
  • Is 'No Worse Than Placebo' Good Enough For New Diabetes Drugs? (Forbes)
  • Takeda Again Sues Par Over Generic Gout Drug (Law 360)
  • FDA approves new vial size for CSL Behring immune treatment (DSN)
  • AstraZeneca initiates Phase III clinical programme for BRCA-mutated cancer drug olaparib (AZ) (PMLive) (Pharma Times)
  • Titan Pharmaceuticals Announces Submission of FDA Meeting Request Regarding Probuphine (Titan)
  • Jennerex Announces That Its Phase 2 Study of Pexa-Vec in Second-Line Advanced Liver Cancer Did Not Meet Its Primary Endpoint (Jennerex)
Pharmaceuticals: General
  • A Broken Promise For Pharma Manufacturers (Law 360)
  • Fighting Back Against Breaking Bad: Using Acura's Pill to Stop Smurfs (In-Pharma)
  • US Awards $7.8M to Further Develop Nitric Oxide-Based Thermal Burn Therapy (In-Pharma)
Medical Devices
  • HIT Stakeholders Propose Modernizing, Limiting FDA Role In Oversight (IHP)
  • BD Gets the Point WIth Third US FDA Approval (In-Pharma Technologist)
  • NIST releases preview of cybersecurity standards (Inside Counsel)
  • HeartWare's pivotal data controversy could affect approval - and sales (EP Vantage)
  • Sonendo Receives 510(k) FDA Clearance For Its Multisonic Ultracleaning System (Sonendo)
  • Zoll Medical lands Defense Dept. medical device contract worth up to $210M (Mass Device)
Assorted And Government
  • Medical foods guidance could open avenues for dietary supplement disease claims, attorney asserts (Nutra Ingredients)
  • Every Unhappy PREA Study is Unhappy in its Own Way (Placebo Control)
  • Taking on More Risk by Doing Less Clinical Data Monitoring (BioClinica)
  • CDC: One-Fourth Of Heart Attack And Stroke Deaths Preventable (NPR) (SCRIP)
  • Generic drugmakers hire new chief lobbyist (The Hill)
Upcoming Meetings And Events
  • 2-5 September 2013: Pharmacovigilance Risk Assessment Committee (EMA)
  • 5-6 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
  • 5 September 2013: ENVI Meeting on Medicines and Innovation (ENVI)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • NICE challenges pharma over development costs (Pharma Times)
  • Industry and drug regulators disagree on which data should remain confidential, including adverse event data (BMJ)
  • Rare diseases on the political - and industry - agenda (SCRIP)
  • Shire's Elvanse/Vyvanse no better than Lilly's Strattera for ADHD, says Germany (SCRIP)
  • EU approves Novartis arthritis drug to treat children two and older (Reuters) (MNT)
  • Tensys Medical Receives CE Mark for TL-400 & TL-300, Latest Generations in Continuous, Non-Invasive Hemodynamic Patient Monitoring System (Tensys)
  • Coherex Medical Announces CE Mark for the WaveCrest LAA Occlusion System (Coherex)

Asia

  • New Bill with separate chapter seeks to end 'identity crisis' for medical devices (PharmaBiz)
  • Indian Industry Calls for Withdrawal of DCGI Directive on State Licensing Authority-Approved Fixed Dose Combinations (PharmaBiz)
  • Demand for reforms in Chinese pharma grows loud (BioSpectrum)
  • GlaxoSmithKline's tussle with China is getting messier and riskier (The Guardian)

Other International

General Regulatory And Interesting Articles

  • Vaccinated Kids Show No Long-Term Ill Effects (Scientific American)
  • Riots, Rage, and Resistance: A Brief History of How Antibiotics Arrived on the Farm (Scientific American)
  • Scientists find possible new way of fighting high blood pressure (Reuters)
  • China 'Catastrophe' Hits 114 Million as Diabetes Spreads (Bloomberg)

Regulatory Reconnaissance #145  - 4 September 2013

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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


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