Regulatory Focus™ > News Articles > Regulatory Reconnaissance (21 June 2013)

Regulatory Reconnaissance (21 June 2013)

Posted 21 June 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • Pharmaceutical scandal: The NHS, the drug firms and the price racket (Telegraph)
  • European Council discusses devices this morning (Clinica)
  • Sanofi's Zaltrap Gets a 'no' From NICE (Pharmafile) (SCRIP) (BioCentury)
  • Sensible guidelines for clinical trials: are current European regulations 'a gift to America'? (European Heart Journal)
  • Indian Pharmaceutical Industry Concerned About Potential Ban on Branded Generics (PharmaBiz)
  • Chinese Regional FDAs To Complete Reforms For CFDA By 2014 (PharmAsia)
  • New Commissioner for Consumer Policy Wants to Maintain EU Medtech Industry's Competitive Edge (MedTech Insider)

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

US

Pharmaceuticals/Biotechnology
  • Eliquis Approval Delayed By Fraud, Dispensing Errors In Pivotal Trial (Pharmaceutical Approvals Monthly) (Free Access)
  • Idenix sees delay in human trials for hep C drug as FDA seeks more data (Reuters) (AP)
  • FDA Soon to Issue Drug Shortage Notification Rule (Health Data Management)
  • FDA Hits Drug Repackager With Mislabeling Suit (Law 360)
  • Black Box Warning Adequate As A Matter Of Law In New Jersey (Drug and Device Law)
  • How To Motivate Off-Label Promotion? Gives Reps Trays Of $50 Bills (Pharmalot)
  • Novartis heart drug gets FDA's 'breakthrough' status (Reuters) (Bloomberg) (PMLive)
  • Paladin's Impavido Could Set A Price Tag For Priority Review Vouchers (Pink Sheet)
  • FDA Approves Generic Riluzole for Apotex, Glenmark and Sun Pharmaceuticals (FDA)
  • FTC v. Actavis: What Does It Mean for Reverse-Payment Settlements? (Life Sciences Law Blog)
  • FDA Ban on Gay Men as Blood Donors Opposed by American Medical Association (ABC) (Think Progress)
  • FDA Approves U.S. Product Labeling Update for Sprycel® (dasatinib) to Include Three-Year First-Line and Five-Year Second-Line Efficacy and Safety Data in Chronic Myeloid Leukemia in Chronic Phase (BMS)
  • Boehringer Ingelheim and Eli Lilly Announce Updates to Prescribing Information for TRADJENTA Tablets and JENTADUETO Tablets (Eli Lilly)
  • BIO Praises Congress for Updating the Vaccine Injury Compensation Program to Cover Newest Seasonal Flu Vaccines (BIO)
  • How Innovative Have Drugmakers Really Been? (Burrill Report)
  • FLU WARS: Egg-free Flublok, quad vax backed for 2013-14 arsenal (SCRIP)
  • PhRMA Joins A New Coalition That Attacks India's Trade Practices (Pharmalot)
Pharmaceuticals: General
  • Why Americans Pointlessly Pay up for Brand Name Drugs (Atlantic)
  • Tighter security coming for prescription database (Miami Herald)
  • Meds to Treat Addiction Often Hard to Get (MedPage Today)
  • Will Genes Ruling Prevent the Next Genentech? (Bloomberg)
Medical Devices
  • FDA approves first genotyping test for patients with hepatitis C virus (FDA) (Abbott) (Fierce)
  • Examining The Scope Of FDA's 510(k) Recission Authority (Law 360)
  • Endo Health Unit Pays $55 Million in Vaginal Mesh Accord (Bloomberg)
  • Draft Guideline for Industry and Food and Drug Administration Staff - Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens (FDA)
  • Baltimore firm to release prescription-only smartphone app (Washington Post)
  • ECG Check iPhone Case Now Available as Prescription or OTC (MedGadget)
  • What can medical device manufacturers do to improve the "Wild West of wireless?" (MedCity News)
  • Class 1 Recall for Verathon's GlideScope Video Laryngoscope Reusable Blades Due to Risk of Breakage (FDA)
  • Fraxel Dual Laser System Receives New FDA 510(k) Clearance For Treatment Of Skin Pigmentation (Solta Medical)
  • iCAD Receives FDA Approval for FujiFilm Aspire HD Digital Mammography System (iCAD)
  • Carestream Receives FDA Clearance for New Technology That Produces High Quality, Low Dose Pediatric X-ray Exams (Carestream)
  • Deaf boy with auditory brain stem implant stunned after hearing dad for first time (CBS)
Assorted and Government
  • With Closer Eye On Indian Units, U.S. FDA Names Altaf Lal As New Country Director (PharmAsia)
  • FDA Appropriations In Senate Largely Matches House, Not That It Will Help (Pink Sheet)
  • FDA Enforcement Report (FDA)
  • House committee admonishes FDA to pick up pace on NDI issue (Nutra Ingredients USA)
  • Toxicological Data on Supplements Cited in FDA Strategic Plan (Natural Products Insider)
  • Quality Assurance as Marketing Strategy (Natural Products Insider)
  • Docs fear Sunshine Act data may be misread (ModernPhysician)
  • FDA Sued for Failing to Confirm Product's Medical Food Status (FDA Law Blog)
  • FDA Releases Strategic Plan in Effort to Modernize Food Safety (Food Product Design)
  • U.S. Approves a Label for Meat From Animals Fed a Diet Free of Gene-Modified Products (NYTimes)
Upcoming Meetings and Events
  • 18 June 2013: Appropriations Committee Hearing on FDA (Senate)
  • 19-20 June 2013: Regulatory Education for Industry (REdI) Conference (FDA)
  • 21 June 2013: Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting (FDA)
  • 24 June 2013: Science Board Meeting (FDA)
  • 25 June 2013: Meeting of the National Biodefense Science Board (DHHS)
  • 25-26 June 2013: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 26 June 2013: General and Plastic Surgery Devices Panel of the Medical Devices Meeting (FDA)
  • 27 July 2013: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 27 June 2013: Mobile Medical App Entrepreneurs: Changing the Face of Health Care (House)
  • 27 June 2013: A Tangle of Trade Barriers: How India's Industrial Policy is Hurting U.S. Companies (House)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

Europe

  • Pharmaceutical scandal: The NHS, the drug firms and the price racket (Telegraph) (BBC)
  • European Council discusses devices this morning (Clinica)
  • New Commissioner for Consumer Policy Wants to Maintain EU Medtech Industry's Competitive Edge (MedTech Insider)
  • Medtech alliances applaud as Obama, European leaders open trade talks (Mass Device)
  • Sanofi's Zaltrap Gets a 'no' From NICE (Pharmafile) (SCRIP) (BioCentury)
  • Sensible guidelines for clinical trials: are current European regulations 'a gift to America'? (European Heart Journal)
  • Germany's IQWiG Pans Sanofi's LyxumiaFor Wrong Comparator Choices (Pink Sheet)
  • Teva is taking its generic version of Viagra to Europe (MedCity News)
  • Regulatory approval opens the way for European launch of new single-size contraceptive diaphragm (EurekAlert)

Asia

  • Indian Pharmaceutical Industry Concerned About Potential Ban on Branded Generics (PharmaBiz)
  • Chinese Regional FDAs To Complete Reforms For CFDA By 2014 (PharmAsia)
  • Japan vaccines briefs: Gardasil and Cervarix; Daiichi Sankyo files NDA (Pharma Letter)
  • BRIC Nations Morphing From 'Emerging' To 'Emerged' In Pharma Markets (PharmAsia)

Other International

  • Australia's TGA Posts Recall Notice for Medtronic's Paradigm Insulin Infusion Sets (TGA)

General Regulatory and Interesting Articles

  • Wireless Power For Medical Devices (MDDI)
  • USAID, Bayer Cooperate to Create Sustainable Contraceptive Market in Africa (Bayer)
  • Taiwan Reports First Human Case of H6N1 Avian-Flu Strain (Bloomberg)

Regulatory Reconnaissance #93 - 21 June 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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