Regulatory Reconnaissance (3 July 2013)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Due to the 4 July Independence Day holiday in the US, Regulatory Focus will not publish on 4-5 July. We will resume as usual on 7 July 2013.

In Focus: US

• Who's Gotten a Breakthrough Product Designation so Far? (Orphan Druganaut)
• Streamlined Antibacterial Development Would Not be Limited To First-in-Disease Products, FDA Says (Pink Sheet)
• Painkiller Abuse Spurs Search for a Safer Opioid Therapy (Bloomberg)
• Medical App Developers Tell House Committee of Major Challenges (MDDI)
• FDA has Made Strides to Improve its Medical Device Review Pathways, But What's the Real-World Experience for Medtech Companies? (Mass Device)

In Focus: International

• ENVI Vote on Medical Devices Regulation Proposal Postponed Until September (MedicalDevicesLegal) (Clinica)
• The EU's Falsified Medicines Directive is Now in Effect (EMA) (Outsourcing Pharma)
• EU Adds Pharmaceuticals to Water Pollution Watch List (Law 360)
• EU Drug Groups to Disclose Payments to Doctors Under Transparency Code (Financial Times) (Pharma Times) (Pharmalot) (PMLive) (Bloomberg)
• ENVI to Hold 11 July 2013 European Commission Meeting on IVDs (ENVI)
• CFDA Suspects QA Defects In J&J On 51 Recalls Since 2005 (PharmAsia)
• Is GlaxoSmithKline's China Probe a Harbinger of More? (Fierce) (Bloomberg)

Comments? Suggestions? Email me at [email protected].

US

Pharmaceuticals/Biotechnology

• FDA Announces Topic of Next Patient-Focused Drug Development Meeting: Narcolepsy (FDA)
• Cliff Notes for Expedited Review (Drug Wonks)
• Who's Gotten a Breakthrough Product Designation so Far? (Orphan Druganaut)
• Streamlined Antibacterial Development Would Not Be Limited To First-In-Disease Products, FDA Says (Pink Sheet)
• Fosamax Ruling Puts Preemption In Play For Branded Drugs (Law 360)
• Oritavancin Phase III Results Support FDA's New Endpoint, Sponsor Says (Pink Sheet)
• Medicines Company to seek oritavancin approval at long last (SCRIP)
• FDA is Working to Expand Question-Based Review Approach From Generic to Innovator Applications (IPQ)
• FDA grants priority review to Roche's leukemia drug (Reuters) (Roche) (SCRIP)
• FDA Precedent on Tramadol NDA Resubmission Shows Agency Efforts to Dull the Pain of a Statutory Prohibition (FDA Law Blog)
• Notes from CDER's June 2013 Townhall (FDA Lawyers Blog) (2)
• Biogen Idec and Sobi Present New Data from the Phase 3 Study of Their Long-Lasting Hemophilia Factor Candidate Alprolix (Biogen) (Pharma Letter)
• Schrodinger's Candidate? Achillion's Sovaprevir On Clinical Hold, But Phase II Combo Trial Continues (Pink Sheet)
• Painkiller Abuse Spurs Search for a Safer Opioid Therapy (Bloomberg)
• Generics Makers Escape NJ Accutane Mass Tort (Law 360)
• BMS, Sanofi Pushed Docs To Overprescribe Plavix, Suit Says (Law 360)
• Par, Alkermes Sue Breckenridge To Block Generic Megace (Law 360)
• Lupin Hit With Suit Over Generic Prezista (Law 360)
• IP: Are "pay for delay" payments anti-competitive or just another settlement agreement? (Inside Counsel)
• Opinion: Anything but Generic: Supreme Court Preemption Opinion Calls for Correction from Congress and the FDA (CPR)

Pharmaceuticals: General

• Rx Painkiller Deaths Rising Faster in Women (MedPage Today) (SCRIP) (CBS) (NYTimes)
• Man Pleads Guilty to Lilly Heist (DD&D)
• Epogen Use Re-Calculation Drives 9.4% Medicare ESRD Bundled Payment Cut In 2014 (Pink Sheet)
• New Oregon Law Hopes To Keep Kids Safe By Making It Harder To Get Vaccine Exemptions (Think Progress)
• Paper Raises Hundreds Of Questions About The Integrity Of Stem Cell Research Group (Forbes)
• Congress Eyes Part B Drug Program Changes (Medpage Today)

Medical Devices

• Transvaginal mesh lawsuits mount ahead of statute of limitations (BioFlash)
• Medical App Developers Tell House Committee of Major Challenges (MDDI)
• Fifty-Five Hospitals to Pay U.S. More Than $34 Million to Resolve False Claims Act Allegations Related to Medtronic's Kyphon (DOJ) (Mass Device)
• FDA Has Made Strides To Improve Its Medical Device Review Pathways, But What's The Real-World Experience For Medtech Companies? (Mass Device)
• Zoll grabs Minnesota startup with FDA challenges (Fierce)
• Integra LifeSciences recall affects Medtronic's Infuse kits (Mass Device)
• basixTOUCH High-Pressure Balloon Inflator Gets FDA OK (MedGadget)

Assorted And Government

• FDA: Fostering innovation to protect national health and security (FDA)
• Congressional Briefing Debunks Anti-Regulatory Myths Behind "Reform" Bills (Center for Effective Gov.)
• NIST outlines draft cybersecurity framework for industry (Federal Times)
• OMB Signs off on CLIA, ANDA Submission from FDA (CLIA) (ANDA)

Upcoming Meetings And Events

• 2 July 2013: FDA Webinar on FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations (FDA) (Online Here)
• Other Upcoming FDA Advisory Committee Meetings And Topics (FDA) 

Europe

• ENVI vote on medical devices regulation proposal postponed until September (MedicalDevicesLegal) (Clinica)
• The EU's Falsified Medicines Directive is Now in Effect (EMA) (Outsourcing Pharma)
• EU Adds Pharmaceuticals To Water Pollution Watch List (Law 360)
• EU drug groups to disclose payments to doctors under transparency code (Financial Times) (Pharma Times) (Pharmalot) (PMLive) (Bloomberg)
• 11 July 2013 European Commission Meeting on IVDs (ENVI)
• EC Underestimated Task of Asking Foreign Govts to Confirm API Quality Says Eucope (In-Pharma Technologist)
• EFPIA Does Not Expect Drug Shortages Due to New EU API Regs (In-Pharma Technologist)
• EC approves Ariad's Iclusig (BioCentury) (Ariad) (BioFlash) (PMLive) (Pharma Times) (Pharma Letter)
• France Suspends Marketing Authorizations of Tetrazepam (Myolastan and Generics) (ANSM)
• Regulatory Flux Tops Concerns of EU Medical Packaging Community, Survey Shows (MedTech Insider)
• U.K. report makes recommendations for regenerative medicine development (BioCentury)
• New Terms of Use for the HTA Core Model (EUNetHTA)

Asia

• CFDA Suspects QA Defects In J&J On 51 Recalls Since 2005 (PharmAsia)
• Is GlaxoSmithKline's China probe a harbinger of more? (Fierce) (Bloomberg)
• Glaxo Awaits Details of China Probe 6 Days After Police Call (Bloomberg)
• Ranbaxy drugs safe says Australian drug regulator (India Times)
• India Approves 50 New Clinical Trials Ahead Of Supreme Court Review (PharmAsia)
• IPA hits out at India's ban on anti-diabetes drug Pioglitazone (India Times)

Other International

• New HIV drugs are "priced beyond reach," warns MSF, but generics helping the situation (Pharma Letter) (Pharma Times)
• One Man's Quest To Make Medical Technology Affordable To All (NPR)
• Devon Medical Receives ANVISA Medical Device Registration and Approval in Brazil Paving Way for Clinical Expansion of extriCARE 2400 Negative Pressure Wound Therapy (NPWT) System (Devon)

General Regulatory And Interesting Articles

• What's the most valuable drug in the global pipeline? (Fierce)
• Mouse Study Predicts Human Drug Response (DD&D)
• Curing Drug-Resistant Tuberculosis In Kids Takes Creativity (NPR)

Regulatory Reconnaissance #101  - 3 July 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 [email protected].