Regulatory Focus™ > News Articles > Regulatory Reconnaissance (30 May 2013)

Regulatory Reconnaissance (30 May 2013)

Posted 30 May 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Six Months Later, Was Caronia the First Amendment Game Changer People Thought it Would Be? (Forbes)
  • FDA Promotes Mary Parks to ODE II (Forbes)
  • USP Deferring Implementation of Elemental Impurities Chapters to Wait on ICH Q3D Guideline (USP)
  • Burned by the FDA: Should FDA Rely on EU Sunscreen Safety to Support Approval? (Marginal Revolution) (WSJ)
  • 'Pay-for-Delay' Decision May Not Resolve Issue (Med Page Today) (SCRIP Intelligence)
  • Class 2 Recalls Associated With Intuitive's Da Vinci Surgical Systems' Promotional Literature (FDA) (FDA) (FDA)

In Focus: International

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

US

Pharmaceuticals/Biotechnology
  • FDA Promotes Mary Parks to ODE II (Forbes)
  • Texas becomes latest state to shut down legislation to slow biosimilar access (GPhA)
  • Supply low, price high for popular Lyme disease antibiotic (Bangor Daily News) (Epoch Times)
  • New Side Effects of Sulfa Drugs Discovered (In the Pipeline)
  • USP Deferring Implementation of Elemental Impurities Chapters to Wait on ICH Q3D Guideline (USP)
  • Another Compounding Pharmacy Issues Recall Notice for All Products (FDA)
  • Burned by the FDA: Should FDA Rely on EU Sunscreen Safety to Support Approval? (Marginal Revolution) (WSJ)
  • 'Pay-for-Delay' Decision May Not Resolve Issue (Med Page Today) (SCRIP Intelligence)
  • FDA Accepts Vimizim BLA and Grants Priority Review Designation (Yahoo)
  • FDA Approves ANDAs for Dr Reddy's Sirolimus, Lupin's Telmisartan; Amlodipine, Mylan's Voriconazole, Alembiz's Metoprolol Tartrate (FDA)
  • Congressional Research Service Releases Report on Drug Compounding (CRS)
  • Opinion: Resources Must Keep Pace with FDA's Increasing Responsibilities to Patients and Consumers (PhRMA)
  • The Sterility Risks in Pharmacy Compounding Can Be Limited, Not Eliminated, Experts Stress at USP Forum (IPQ)
  • FDA Working with Fresenius Kabi to Alleviate Drug Shortages (FDA)
  • DEA Disagrees with Firm's Meth-Resistant Claims (PharmPro)
  • GSK and Genmab announce positive top-line results from pivotal trial of ARZERRA® (ofatumumab) combined with chlorambucil in previously untreated chronic lymphocytic leukaemia (GSK) (SCRIP Intelligence) (BioCentury)
  • Bayer Joins the Combo Drug NCE Challenge Club; Petitions FDA for 5-Year Exclusivity for NATAZIA (FDA Law Blog)
  • Eli Lilly Sues Perrigo To Block Generic Testosterone Drug (Law 360)
  • Merck Loses Battle Over Outsourced Vioxx Lawsuit In Kentucky (Pharmalot)
  • OMB Submission: Requirements for Submission of Labeling for Human Prescription Drugs and Biologics in Electronic Format (FDA)
  • Aveo Chairman: Expect 'Consequences" From Kidney Cancer Drug Debacle (The Street)
  • FDA: Allergy Meds Could Affect Your Driving (FDA)
  • Why DIY fecal transplants are a thing (and the FDA is only part of the reason) (PLoS)
  • RedHill Biopharma views regulatory pathway for RHB-101 in CHF and hypertension (The Pharma Letter)
  • Anacor Pharmaceuticals Announces Successful Completion of Pre-NDA Communications With the FDA for Tavaborole (Business Wire)
  • Huge Drug Cost Disparities Seen in Health Overhaul (AP)
  • How OxyContin's Pain Relief Built 'A World Of Hurt' (NPR)
  • Biogen Idec's MS Drug Launch Is Going Amazingly Well. These Two Graphs Prove It (Forbes)
  • Bankrupt K-V Settles Texas Medicaid Fraud Suit For $3M Claim (Law 360)
Medical Devices
  • 2013 Meeting Materials of the Orthopaedic and Rehabilitation Devices Panel (FDA)
  • Breathe Technologies Sleep System Receives FDA Clearance (PR Newswire)
  • Class 1 Recalls for Nephron Pharmaceuticals' EX Breathe Atomizer (FDA) (FDA) (FDA)
  • Class 2 Recalls Associated With Intuitive's Da Vinci Surgical Systems' Promotional Literature (FDA) (FDA) (FDA)
  • 10th Circ. Reverses Zimmer Win In Knee-Implant Injury Suit (Law 360)
  • How reliable are blood glucose meters? Post-market studies raise concerns (Mass Device)
  • iTraumaCare's medical device cleared to sell in U.S. (San Antonio Biz Journal)
Assorted and Government
  • Caronia And The First Amendment Defense To Off-Label Marketing: A Six Month Re-Assessment (Forbes)
  • Sunlight as Disinfectant - New Rules on Disclosure of Industry Payments to Physicians (NEJM)
  • The Sunshine Act - Effects on Physicians (NEJM)
  • Cedars-Sinai registry seeks increased female engagement in cancer trials (Pharma Times)
  • Meetings: Arthritis Advisory Committee (FDA)
  • CTTI Welcomes New Members to Its Steering Committee (CTTI)
Upcoming Meetings and Events
  • 29-30 May 2013: Medical Countermeasure Regulatory Science Symposium (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • More Noncompliant Implants Marketed by Ceraver (Medtech Insider)
  • Diverging EU medtech reg views still need reconciling (Clinica)
  • Biogen Idec Delays Launch of Tecfidera, Seeks Regulatory Data Protection (Boardvote)
  • Beyond Ranbaxygate: trust, mistrust and Indian generics (SCRIP Intelligence)
  • NICE now backs Forxiga for diabetes (BioCentury) (Pharma Times) (SCRIP Intelligence) (Pharma Letter)
  • Chinese regulators warn of software glitch in Philips' Pinnacle3 radiation therapy software (Mass Device)
  • Vimizim MAA Validated by the EMA (Boardvote)
  • Japan PAFSC Committee Approves Five New Drugs Including 13-Valent Pneumococcal Vaccine (PharmAsia News)
  • Japan's Tanabe Mitsubishi Files For Approval Of Canagliflozin (PharmAsia News) (SCRIP Intelligence) (BioSpectrum)
  • India Pharma, Pfizer Continue Words War Over IP Protections (PharmAsia News)
  • U.K. regulators warn on Unomedical's endotracheal tubes (Mass Device)
  • Regulatory Harmonization Institute Workshop for U.S. - Japan Health Care Study Group: Emerging Markets Present Opportunities for Collaboration and Innovative Partnerships (Business Wire)
  • Chinese HFMD vaccine impresses in Phase III (Fierce)
  • CDSCO labs declare 53 samples as substandard in 6 months under drug alert system (PharmaBiz)

General Regulatory and Interesting Articles

  • NSAID painkillers increase risk of heart attacks by a third (FT) (Bloomberg) (MHRA)
  • The Latest Artificial Heart: Part Cow, Part Machine (MIT Tech Review)

Regulatory Reconnaissance #77 - 30 May 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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