Regulatory Focus™ > News Articles > Regulatory Reconnaissance (29 May 2013)

Regulatory Reconnaissance (29 May 2013)

Posted 29 May 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Independent Re-Adjudication Of RECORD Confirms Safety Of Rosiglitazone (BioCentury) (Forbes) (SCRIP)
  • FDA's Bakul Patel: For mobile medical apps, patient safety first (Fierce)
  • Legal Group Calls on FDA to Withdraw Device Recall Guidance (WLF)
  • Compounding Pharmacy Initiates Recall of all Products, Citing Sterility (FDA)
  • Legislator: Ranbaxy Case Shows FDA Was Asleep at the Wheel (CBS)
  • Supreme Court Could Allow Feds to Reverse State Actions Against Industry (Drug and Device Law) (SCOTUS Blog)
  • New Warning Letters Posted (FDA)

In Focus: International

  • ENVI Holds Medical Device, IVD Meeting (Webcast)
  • India's CDSCO Touts Four-Year Achievement Record (CDSCO)
  • Generic drugs: Watchdogs probe pay-for-delay deals (FT)
  • France Finalizes 'Sunshine' Provisions for Pharma (FDA News) (Policy Med)
  • Australia Proposes Automatically Adopting New Versions of the PIC/S GMPs (TGA) (TGA)

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

US

Pharmaceuticals/Biotechnology
  • Independent Re-Adjudication Of RECORD Confirms Safety Of Rosiglitazone (BioCentury) (Forbes) (SCRIP)
  • Compounding Pharmacy Initiates Recall of all Products, Citing Sterility (FDA)
  • ISTA excluded from Medicare in $33.5M off-label settlement (Fierce)
  • Legislator: Ranbaxy Case Shows FDA Was Asleep at the Wheel (CBS)
  • FDA Expanded Access Guidances Fail To Achieve Détente With Advocates (The Pink Sheet)
  • Pozen Announces FDA Acceptance of Filing of New Drug Application for PA32540/PA8140 Tablets (Boardvote)
  • Perrigo Announces FDA Final Approval For Generic Equivalent To Sanctura XR (PR Newswire)
  • FDA Approves Efficacy Supplements for Novartis' Gilenya (Fingolimod) and BMS's Kombiglyze (Metformin HCl; Saxagliptin HCl) (FDA)
  • FDA Approves Paddock's ANDA for Trospium Chloride (#201291), Banner Pharmacaps' Calcitriol (#091174) (FDA)
  • Bad Birth Control Packaging Led To Pregnancy, Suit Says (Law 360)
  • FDA approves Amneal generic version of Suboxone (DSN)
  • Report: Drug Supply Chains Are Stronger, but More Steps Are Needed to Reduce Risks in PEPFAR Program (GAO)
  • BARDA awards Cempra up to $58M for antibiotics (BioCentury)
  • The Politics Of Federal Track & Trace Legislation (RxTrace)
  • Unsurprising FDA 'breakthrough' designation for Alexion's hypophosphatasia drug (SCRIP Intelligence)
  • Making The Call: Pharmacyclics FDA Drug Approval Before Year End (The Street)
Medical Devices
  • FDA's Bakul Patel: For mobile medical apps, patient safety first (Fierce)
  • Legal Group Calls on FDA to Withdraw Device Recall Guidance (WLF)
  • Half-year Report 2013: FDA Medical Devices Warning Letter Statistics - 2 New Deficiency Group in the Top 5 (ECA)
  • Heli-FX Guide Designed to Treat Wide Neck Abdominal Aortic Aneurysms Receives FDA Clearance (Business Wire)
  • Covidien Nellcor Pulse Oximeters Receive FDA 510(k) Clearance with Labeling for Use in Newborn Screening for Critical Congenital Heart Disease (Covidien)
  • Medical Device Firm iTraumaCare Receives FDA 510(k) Clearance for iTClamp Hemorrhage Control System (Business Wire)
  • OMB Certifies FDA request for clearance of rules on clinical data acceptance, symbol labeling (OMB) (OMB)
Assorted and Government
  • Supreme Court Could Allow Feds to Reverse State Actions Against Industry (Drug and Device Law) (SCOTUS Blog)
  • New Warning Letters Posted (FDA)
  • FDA's Aggressive Inspections Can Deep-Six Pending Filings (McGuire Woods)
  • FDA Cites Park Doctrine in a Different Context (FDA Law Blog)
  • Organisational Fears Act as a Barrier to Adaptive Clinical Trial Designs, Not Regulatory Bodies (Eye for Pharma)
  • Opinion: "Regulatory Paralysis Act" Threatens to Weaken Nation's Primary Health, Safety and Environmental Laws (Coalition for Sensible Safeguards)
  • CEOs put their stamp of approval on regulations bill (The Hill)
  • Pa. parents say organ donation rules unfair to sick 10-year-old, demand change (CBS)
Upcoming Meetings and Events
  • 29-30 May 2013: Medical Countermeasure Regulatory Science Symposium (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • ENVI Holds Medical Device, IVD Meeting (Webcast)
  • CDSCO Touts Four-Year Achievement Record (CDSCO)
  • Generic drugs: Watchdogs probe pay-for-delay deals (FT)
  • France Finalizes 'Sunshine' Provisions for Pharma (FDA News) (Policy Med)
  • Australia Proposes Automatically Adopting New Versions of the PIC/S GMPs (TGA) (TGA)
  • European Commission Approves Stribild, a New Single Tablet Regimen for the Treatment of HIV-1 Infection (Business Wire) (BioCentury) (PMLive) (The Pharma Letter)
  • Africa's Malaria Battle: Fake Drug Pipeline Undercuts Progress (WSJ)
  • The Indian Medical Association asks DGCI to probe quality of Ranbaxy's drugs (India Times)
  • CFDA Announces Quality Standards For In Vitro Diagnostic Reagents (PharmAsia News)
  • China FDA Hauls Up Six Major Domestic Drug Firms For Illegal Conduct (PharmAsia News)
  • Advanced Biological Laboratories (ABL) SA Announced That It Has Received CE Mark Certification to Market Its Innovative Patient Monitoring Application TherapyEdge in Europe and Other Markets That Recognize the CE Mark (Business Wire)
  • Teleflex Announces European Market Clearance for its Arrow® GPSCath® Balloon Dilatation Catheter (Boardvote)
  • Sucampo Pharmaceuticals Achieves Orphan Designation for Unoprostone Isopropyl for Treatment of Retinitis Pigmentosa by European Medicines Agency (Business Wire)
  • Germany's HTA Process May Ease After Scientific Associations' Input (The Pink Sheet)

General Regulatory and Interesting Articles

  • Pharmaceutical toxicology: Designing studies to reduce animal use, while maximizing human translation (Science Direct)
  • 'Low-T' drugs raise medical questions (CBS)
  • Valuable Alternative To Animal Models Predicts Reactions To Novel Drugs And Cosmetics (MNT)

Regulatory Reconnaissance #76 - 29 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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe