Regulatory Reconnaissance: Taiwan, Japan Eye Drug Regulatory Harmonization (8 January 2013)

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In Focus: US

• FDA Advisory Panel To Review New Heart Failure Drug From Novartis (Forbes) (BioCentury)
• Warning and NOV Letter Summary - 4th Quarter 2013 (Eye on FDA)
• FDA to assess drug release of medicated chewing gums (NI-USA)
• Patients, Consumer Advocates Question Hip Implant Settlement (NPR)
• US cracks down on 'miracle' weight loss cures (The Hill) (FTC) (NYTimes) (CBS) (NBC) (NI-USA) (Tan Sheet-$)

In Focus: International

• Taiwan, Japan Eye Drug Regulatory Harmonization To Curb Costs (PharmAsia-$)
• Indian Govt considering revising GMP regulations to make them compliant with WHO's GMP Certification (PharmaBiz)
• EMA Releases Guideline Annex on Definitions for Good Pharmacovigilance Practices (EMA)
• Blood Pressure Drug Ad Prompts Japan to File Criminal Complaint Against Novartis (MedIndia) (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

• FDA Advisory Panel To Review New Heart Failure Drug From Novartis (Forbes) (BioCentury)
• Warning and NOV Letter Summary - 4th Quarter 2013 (Eye on FDA)
• FDA to assess drug release of medicated chewing gums (NI-USA)
• PhRMA: We Support a "Strong, Sufficiently-Resourced FDA" (PhRMA)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

• Pharmacyclics jumps on ibrutinib data (BioCentury) (Pharmafile) (PMLive) (Forbes) (Pharma Letter-$) (Pink Sheet-$) (MM&M)
• Shield iron deficiency drug in IBD patients shines in Ph III (Pharma Times)
• NPS Pharmaceuticals Announces FDA Acceptance of Biologics License Application for Natpara for the Treatment of Hypoparathyroidism (Press)
• DiaVacs Diabetes Drug Gets Orphan Drug Status (DD&D)

US: Pharmaceuticals and Biotechnology: General

• Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs -- Proposes to Ban Doctors and Eliminate Certain Pharmaceuticals from Part D (Policy and Medicine)
• Returns may suffer as drugmakers compete in crowded cancer field (Reuters)
• Key to peds rare disease R&D success? Parents, advocates (SCRIP-$)

US: Medical Devices

• Patients, Consumer Advocates Question Hip Implant Settlement (NPR)
• Gentle, Simple SinuSys Vent-Os Sinus Dilation System Obtains FDA Clearance (Press)
• Samsung lands FDA clearance for health app (Mass Device) (MedGadget)
• Delphinus Medical's SoftVue Ultrasound Tomography System Cleared in U.S. (MedGadget)
• Nipro Diagnostics, Inc. Initiates Voluntary Recall of Certain TRUEbalance and TRUEtrack Blood Glucose Meters (FDA)
• Most surgeons blind to implanted device costs (Fierce)

US: Dietary Supplements

• US cracks down on 'miracle' weight loss cures (The Hill) (FTC) (NYTimes) (CBS) (NBC) (NI-USA) (Tan Sheet-$)

US: Assorted And Government

• Think America has the world's best health care system? You won't after seeing this chart. (Washington Post)

Upcoming Meetings And Events

• 10 January 2013: National Biodefense Science Board Meeting (DHHS)
• 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
• 2014 FDA OAGS Small Business Outreach Vendor Fair (FDA)
• Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

• IQWiG says added benefit of GSK's Tafinlar not proven (Pharma Letter-$) (Press)
• Added benefit of Sanofi's Aubagio not proven, says IQWiG (Pharma Letter-$)
• EMA Releases Guideline Annex on Definitions for Good Pharmacovigilance Practices (EMA)
• Daiichi Sankyo files edoxaban in EU (SCRIP-$) (Pharma Letter-$) (BioCentury)
• Daclatasvir Marketing Authorization Application for Treatment of Chronic Hepatitis C Validated for Accelerated Regulatory Review by the European Medicines Agency (Press)
• Are drugs companies transparent enough about their products? (Channel 4)

Asia

• Indian Govt considering revising GMP regulations to make them compliant with WHO's GMP Certification (PharmaBiz)
• India to amend Rule 96 of D&C Rules for labeling vaccines with specific reference to origin of vaccine (PharmaBiz)
• Taiwan, Japan Eye Drug Regulation Streamlining To Curb Costs (PharmAsia-$)
• Blood Pressure Drug Ad Prompts Japan to File Criminal Complaint Against Novartis (MedIndia) (PharmAsia-$)
• China Vows Steps To Deal With Shortage Of Hyperthyroidism Drug (PharmAsia-$)

General Regulatory And Interesting Articles

• Why drug discovery is hard - Part 2: Easter Island, Pit Vipers; Where do drugs come from? (Scientific American)
• South Korea develops world's first cancer-treating nanorobot (Reuters)
• Compounding pediatric medicines from adult preparations may result in poor content uniformity (Press)
• On-demand vaccines possible with engineered nanoparticles (Press)

Regulatory Reconnaissance #231 - 8 January 2014

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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Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at [email protected].