Regulatory Focus™ > News Articles > Regulatory Reconnaissance (12 August 2013)

Regulatory Reconnaissance (12 August 2013)

Posted 12 August 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Stakeholders Still Confused About Breakthrough Standards, Difference From Fast Track (Pink Sheet)
  • Drug Review Personnel Costs Dropping, Remain "Completely Normal," FDA Says (Pink Sheet)
  • Experts: FDA Guidance on Risk-Based Trial Monitoring Most Effective for Phase II, IV (Outsourcing Pharma)
  • FDA's Temple To Sponsors: Stop Slaving Over The Mean, Look At Range Of Responses (Pink Sheet)
  • The Cost Of Creating A New Drug Is $5 Billion, Pushing Big Pharma To Change (Forbes) (Forbes)
  • FDA's "Breakthrough" Exceeds Expectations; Will It Break The Bank? (RPM Report)
  • Drug Industry Asks FDA Policy Council To Examine Novel Trials, CER (IHP)
  • HIV Survivors Seek Drug Advances as FDA Eases Approvals (Bloomberg)
  • Judge Knocks Bellwether Pool In Boston Scientific Mesh MDL (Law 360)
  • FDA Responds to Congress Letter on NDI (Natural Products Insider)
  • Three Choices for FDA Budget for FY 14 … Maybe (Strengthen FDA)

In Focus: International

  • Teva gets EU nod for Neulasta 'biobetter' (Pharma Times)
  • EC approves Celgene's pomalidomide (Celgene) (BioCentury) (Pharma Letter)
  • Novartis Hit by Scandal Over Japanese Drug Studies (WSJ)
  • China Viread patent move part of wider access push? (SCRIP)
  • Burden of Pre-Inspection Submission Requests from Agencies Outside the US and Europe is Growing (IPQ)

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

US

Pharmaceuticals/Biotechnology
  • Stakeholders Still Confused About Breakthrough Standards, Difference From Fast Track (Pink Sheet)
  • Drug Review Personnel Costs Dropping, Remain "Completely Normal," FDA Says (Pink Sheet)
  • Experts: FDA Guidance on Risk-Based Trial Monitoring Most Effective for Phase II, IV (Outsourcing Pharma)
  • FDA's Temple To Sponsors: Stop Slaving Over The Mean, Look At Range Of Responses (Pink Sheet)
  • The Cost Of Creating A New Drug Is $5 Billion, Pushing Big Pharma To Change (Forbes) (Forbes)
  • FDA's "Breakthrough" Exceeds Expectations; Will It Break The Bank? (RPM Report)
  • Drug Industry Asks FDA Policy Council To Examine Novel Trials, CER (IHP)
  • HIV Survivors Seek Drug Advances as FDA Eases Approvals (Bloomberg)
  • REMS Assessment Paradigm To Be RE-AIMed By FDA; "Pressure-Testing" Needed (Pink Sheet)
  • How To Speak REMS: Structured Product Labeling Seen As Route To Standardization (Pink Sheet)
  • Stairway To Heaven: REMS Website Integrated With Health Care Systems (Pink Sheet)
  • Whose Burden Is It Anyway? REMS' Health Care Impact Belongs To FDA, PhRMA Says (Pink Sheet)
  • FDA Panel Endorses Riociguat For CTEPH Amid Worries It Will Displace Surgery (Pink Sheet)
  • NanoViricides Announces that DengueCide Has Received Orphan Drug Designation From the US FDA (NanoViricides)
  • Eisai Says FDA Erroneously Triggered NCE Exclusivity Start Dates Before DEA Controlled Substance Scheduling Permitted Marketing (FDA Law Blog)
  • FDA Approves Alvogen Pine Brook's Disulfiram (ANDA #091681), Claris' Levofloxacin (#091397), Sandoz's Griseofulvin (#91592) (FDA)
  • Depomed Sues Banner, Watson Over Proposed Generic Zipsor (Law 360)
  • Glenmark gets USFDA nod for alcohol abstinence drug (India Times)
  • Vical drops cancer therapy after trial failure, shares plunge (Reuters)
  • MedGuide Updates Posted (FDA)
Pharmaceuticals: General
  • NYTimes Op-Ed: Highly Effective Drugs Should be Free for all Patients (NYTimes)
  • U.S. Sues PharMerica for Allegedly Dispensing Drugs Without Prescriptions (WSJ) (Reuters) (Modern Healthcare) (DOJ)
  • U.S. Probes Use of Antipsychotic Drugs on Children (WSJ)
  • OxyContin maker closely guards its list of suspect doctors (LATimes)
Medical Devices
  • Judge Knocks Bellwether Pool In Boston Scientific Mesh MDL (Law 360)
  • Class 1 Recall: Nova Max Glucose Test Strips due to False Readings (FDA)
  • FDA Submits Notice to OMB on Pediatric Uses of Medical Devices (OMB)
  • May 2013 PMA Approvals (FDA)
Assorted And Government
  • FDA Responds to Congress Letter on NDI (Natural Products Insider)
  • Dogs trained to help sniff out ovarian cancer (USA Today)
  • Three Choices for FDA Budget for FY 14 … Maybe (Strengthen FDA)
  • Harvard Pilgrim defends drug policy move to limit reimbursement for compounded drugs (Boston Herald)
  • Supplement Maker Can't Shake Glucosamine False Ad Action (Law 360)
  • Biotechs push to save tax credit for rare-disease medicine makers (Boston Herald)
  • New regulations czar enters fray, promises to pare red tape (The Hill)
  • SCRIP's US Capitol Capsule (SCRIP)
  • Pentagon's Giant Blood Serum Bank May Provide PTSD Clues (Scientific American)
  • New Muscle Drugs Could Be The Next Big Thing In Sports Doping (NPR)
Upcoming Meetings And Events
  • 15 August 2013: Alliance for a Stronger FDA/FDA International Programs Meeting (Strengthen FDA)
  • 16 August 2013: Risk Communication Advisory Committee (FDA)
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

Asia

  • Novartis Hit by Scandal Over Japanese Drug Studies (WSJ)
  • China Viread patent move part of wider access push? (SCRIP)
  • China steps up its scrutiny of western drugs prices (FT) (FT)
  • China launches Sanofi probe following bribery allegations (SCRIP) (NYTimes) (Reuters)

Other International

  • Burden of Pre-Inspection Submission Requests from Agencies Outside the US and Europe is Growing (IPQ)
  • Next Meeting of the International Generic Drug Regulators Pilot (IGDRP) Scheduled (TGA)

General Regulatory And Interesting Articles

  • "Lung on a chip" tech set to revolutionize scientific drug testing (CBS)
  • Six Reasons Why Giving Scientists Big Bonuses Won't Fix Pharma R&D (Xconomy)
  • Simple screen detects fake and substandard antibiotics (Securing Industry)

Regulatory Reconnaissance #129  - 12 August 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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