Regulatory Focus™ > News Articles > Regulatory Reconnaissance (5 June 2013)

Regulatory Reconnaissance (5 June 2013)

Posted 05 June 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • European Commission Amends 2012/715/EU to add Japan to list of third countries with comparable GMPs for APIs (EU)
  • Guideline on the use of bovine serum in the manufacture of human biological medicinal products (EMA)
  • J&J Recalls 32 Million Boxes Of Contraceptives From 43 Countries (Pharmalot) (Reuters) (Law 360)
  • Japan to allow online sales of 99% of all OTC drugs (Japan Times)
  • GSK Investigates Alleged Issues With Journal Publication (PharmAsia News)

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

US

Pharmaceuticals/Biotechnology
  • FDA's Avandia Meeting Today and Tomorrow (Webcast Link) (Pharmalot) (FDA) (Forbes) (Reuters) (PMLive)
  • Can FDA's New Transparency Survive Avandia? (Placebo Control)
  • M2: eCTD Specification Questions & Answers and Change Requests Companion Document (FDA)
  • Another Novartis Manufacturing Facility Gets An FDA Lashing (Pharmalot)
  • A Fumble Return, Not a Punt Return, in the First FDA Resolution of a 180-Day Exclusivity Punt Case (FDA Law Blog)
  • OGD 'Attack' Team to Prioritize Reviews of Supplements for Shorted Drugs (FDA News)
  • Regulatory struggles force Aveo to cut 140 jobs (Xconomy) (Biz Journal) (SCRIP) (Fierce) (PMLive)
  • FDA Approves ANDAs for Hikma Farmaceutica's Zoledronic Acid, Apotex's Candesartan Cilexetil; Hydrochlorothiazide, Dr Reddy's Candesartan Cilexetil (FDA)
  • Public Health Workers Urge FDA Action On Antibiotics (Law 360)
  • Discrepancies Between FDA Approval and CMS Coverage of Devices and Part B Drugs (Tufts)
  • FDA clamps clinical hold on Pluristem PhII stem cell trial (Fierce) (Pluristem) (SCRIP)
  • Group of strong antibiotics linked to kidney injury (Reuters)
  • FDA grants priority review to BMS/AZ lipodystrophy drug metreleptin (BMS) (SCRIP) (Pharmafile) (PMLive)
  • CorePharma gets closeout letter for NJ plant (Fierce)
  • Propofol Off FDA List but Manufacturing Issues Cause 75% of Shortages (In-Pharma Technologist)
  • Feinstein to FDA: Ensure Access to Safe, Effective Sunscreen Products (Feinstein)
  • FDA's Rick Pazdur Receives ASCO Award (FDA)
  • Fecal transplants may stall as FDA cracks down on docs (NBC)
  • More men treated for low T, some without evidence (Reuters)
Medical Devices
  • Medtronic wins FDA nod, CE mark for angioplasty balloon (Fierce) (Medtronic)
  • FDA and MDMA: Moving Forward Together (Mass Device)
  • St. Jude kicks off renal denervation study for FDA approval (Fierce)
  • Providence Medical Technology Announces U.S. Regulatory Clearance of PMT Cervical Cage (Business Wire)
  • Blue Belt Technologies Announces US FDA Clearance to Market its STRIDE Unicondylar Knee System (Business Wire)
  • FDA Issues Class 1 Recall for Medtronic's NIM TriVantage EMG Endotracheal Tube (FDA)
Assorted and Government
  • House committee seeks slight FY14 bump for FDA (BioCentury)
  • New Batch of FDA Warning Letters Posted (FDA)
  • CROs Slowly Shifting to Adaptive Clinical Trial Designs (Outsourcing Pharma)
  • Caging the 'patent trolls': Obama calls for greater IP protections (SCRIP)
  • Sebelius won't intervene in girl's transplant case (NBC) (Medical Daily) (Bloomberg)
Upcoming Meetings and Events
  • 3 June 3013: House Energy and Commerce Committee to Vote on Track and Trace, ADUFA/AGDUFA Bills Bill (E&C) (The Hill)
  • 5-6 June 2013: Two-Day Avandia Meeting (FDA)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

Europe

  • European Commission Amends 2012/715/EU to add Japan to list of third countries with comparable GMPs for APIs (EU)
  • Swedish Regulators Call for Removal of PIP Breast Implants from the Market (MHRA)
  • Guideline on the use of bovine serum in the manufacture of human biological medicinal products (EMA)
  • GlucoTrack DF-F Noninvasive Glucose Meter Receives CE Mark (MedGadget)
  • Tightening health budgets on both sides of the Atlantic leading to crackdowns on patent settlements, says EIU analyst (The Pharma Letter)
  • European Commission Authorizes a Ukraine Laboratory to monitor the effectiveness of Rabies Vaccines (EC)
  • French Sunshine Act: France Issues Final Decree - Reporting Retroactive to January 1, 2012 (Policy and Medicine)
  • 'Evergreen' Drugs Extend Pharma Patents, May Have Cost Swiss Consumers 30M Euros (Medical Daily)

International: Other

  • J&J Recalls 32 Million Boxes Of Contraceptives From 43 Countries (Pharmalot) (Reuters) (Law 360)
  • Japan to allow online sales of 99% of all OTC drugs (Japan Times)
  • GSK Investigates Alleged Issues With Journal Publication (PharmAsia News)
  • Australia: Summary of fees and charges at 1 July 2013 (TGA)
  • Australia Considers Reforming its Framework for Regulating Pharmaceutical Compounders (TGA)
  • TGA, Medsafe Launch Joint Trans-Tasman Warning System (FDA News)
  • ADHD In Japan Starting To Find An Easier Regulatory Path; Shire Advances Pipeline (PharmAsia)
  • Pfizer gets relief in patent revocation case for anti-cancer drug 'Sutent' (India Times)
  • Zydus Cadila gets DCGI nod for launch of its NCE for diabetes (India Times)

Regulatory Reconnaissance #81 - 5 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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