Regulatory Focus™ > News Articles > Regulatory Reconnaissance (24 October 2013)

Regulatory Reconnaissance (24 October 2013)

Posted 24 October 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know:

In Focus: US

In Focus: International

  • IVD industry loses battle for 5-year transition as EU regulatory reform plans progress (Clinica-$)
  • EU data-protection amendments could undermine health research (Pharma Times)
  • Biosimilar Naming Compromise In Europe May Protect Fledgling MAb Competitors (Pink Sheet-$)
  • WHO: Drug-Resistant TB Diagnoses Are Rising (WSJ-$) (Kaiser) (PAHO)
  • Want data on drugs? Look for clinical study reports (Reuters)

US: Pharmaceuticals/Biotechnology

  • FDA issues positive review for Gilead's hep C drug (AP) (Reuters)  (Fierce) (Pink Sheet-$) (SCRIP-$) (BioCentury)
  • Senators To FDA: Has Biosimliar Naming Policy Changed? (Pharmalot) (BioCentury) (IHP-$)
  • Repros reprices as FDA hints more Androxal studies needed (SCRIP-$) (Reuters) (The Street) (Pink Sheet-$) (BioCentury) (Fierce)
  • PhRMA Appeals Court's Decision To Uphold Alameda County's Prescription Drug Disposal Program (CA Healthline)
  • New group of oral hepatitis C drugs near U.S. approval (Reuters) (MedPage Today)
  • Death penalty policy causes docs to worry over obtaining anesthesia for patients (MedCity News)
  • Patient Perspectives Floated As Part Of PhRMA's Trial Data Sharing Initiative (IHP-$)
  • Rigel to drop skin disease drug after trial failure (Reuters)
  • FDA Grants Breakthrough Therapy Designation to cPMP Replacement Therapy for Patients with Molybdenum Cofactor Deficiency (MoCD) Type A (Press)
  • Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA) (2)
  • FDA reschedules meeting for grass allergy products (BioCentury)
  • Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals (FDA)
  • FDA Announces Minor Use/Minor Species (MUMS) Grant Program Request for Applications Open Period due January 3, 2014 (FDA)
  • Hospira Unveils New Quality Laboratory and Investments at Rocky Mount, N.C., Plant (Press)
  • Tainted Steroid Shots Led to Varying Ailments  (MedPage Today) (NEJM) (2)
  • Cephalon Sues Eagle Over Plans For Liquid Treanda (Law 360-$)
  • Medivation and Astellas reveal positive Phase III results for prostate cancer drug (Pharma Letter-$) (BioCentury)
  • FDA Talk about Prescription Month Campaign to Stop Counterfeit and Illegal Medical Products (Policy and Medicine)

US: Pharmaceuticals and Biotechnology: General

  • AARP warns trade deal could lock in high drug prices (The Hill)
  • Healthcare.Gov Contractor Is Also Assembling The Sunshine Act Website (Pharmalot)

US: Medical Devices

  • Allergan cheek filler Juvederm Voluma XC OK'd in US (Press) (PSCRIP-$) (Mass Device)
  • Single QMS audit program pilot for medical devices set for January 2014 (Mass Device)
  • Medtronic recalls dilation catheters over labeling issue (Mass Device)
  • July 2013 PMA Approvals (FDA)
  • Bard vaginal mesh verdict sticks as judge reaffirms $2M award (Fierce)
  • MedStream Programmable Infusion Pump and Refill Kits by Codman and Shurtleff: Class 1 Recall - Drug Over Infusion (FDA)
  • Nonin Medical Announces FDA Clearance of Nonin Bluetooth Smart Model 3230 Finger Pulse Oximeter for OEM/ehealth Applications (Press)
  • Varian Medical lands FDA clearance for treatment software (Mass Device)

US: Assorted And Government

  • US firms lobbying to protect patents in India: Report (BioSpectrum)
  • FDA Enforcement Report - Week of October 23, 2013 (FDA)

Upcoming Meetings And Events

  • 21-22 October 2013: Public Workshop on Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT II) (FDA)
  • 22-23 October 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA) (POSTPONED)
  • 23 October 2013: Investigational Device Exemption Process Meeting (FDA) (FDA)
  • 22-23 October 2013: FSMA Public Meeting Concerning Proposed Rules on Foreign Supplier Verification Programs and the Accreditation of Third-Party Auditors/Certification Bodies (FDA)
  • 24-25 October 2013: Antiviral Drugs Advisory Commitee Meeting (FDA) (Day 2)
  • 31 October 2013: Data Harmonization for Patient-Centered Clinical Research (IOM/PCORI)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • IVD industry loses battle for 5-year transition as EU regulatory reform plans progress (Clinica-$)
  • EU data-protection amendments could undermine health research (Pharma Times)
  • Biosimilar Naming Compromise In Europe May Protect Fledgling MAb Competitors (Pink Sheet-$)
  • Proposed EU Regulation to improve safety, but at what cost (Clinica-$)
  • Basilea's ceftobiprole approved for pneumonia in Europe (BioCentury) (Press)
  • Celgene's Revlimid knocked-back by NICE (PMLive)
  • LEO Pharma Committs to Making Clinical Trials Results Publicly Available (AllTrials) (Pharma Times)
  • Generics "are no panacea," EU states warned (Pharma Times)


  • Boston Scientific Alair Bronchial Thermoplasty System Approved In China (Press)
  • EOS imaging Obtains Regulatory Authorization to Sell Its Products in Japan (Press)
  • Zynex Receives SFDA Clearance to Market Neuromove(TM) Stroke Recovery Device in China (Press)

Other International

  • WHO: Drug-Resistant TB Diagnoses Are Rising (WSJ-$) (Kaiser) (PAHO)
  • Australia's TGA Warns Of Shortage Of Often-Vital Overactive Thyroid Drug (PharmAsia-$)
  • Ghana to probe import of Indian anti-malarial drug  (BioSpectrum)
  • Australia and NZ add to OxyElite Pro's global woes (Nutra Ingredients)

General Regulatory And Interesting Articles

  • Want data on drugs? Look for clinical study reports (Reuters)

Regulatory Reconnaissance #186 - 24 October 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.

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