Regulatory Focus™ > News Articles > Regulatory Reconnaissance (25 June 2013)

Regulatory Reconnaissance (25 June 2013)

Posted 25 June 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • FDA Regulatory Change Could Create Opening in Generic Liability Shield (Pink Sheet) (Law 360) (Biocentury)
  • High Court Vacates 2 Pay-for-Delay Rulings Post-Actavis (Law 360)
  • Woodcock Sees Acceleration of FDA Breakthrough Approvals, Especially in Cancer (Biocentury)
  • Roche Recalls Diagnostic Test on Account of Potential for Error Message (FDA) (FDA) (FDA)
  • Senate Panel Confirms Regulatory Czar (the Hill)
  • FDA Field office so Dysfunctional it Needs to Hire Outside Training to Conduct Team-Building Exercises (FedBizOpps)
  • Depuy Orthopaedics Wins FDA Approval for Customized Knee Implant System (Mass Device)

In Focus: International

  • Sanofi Chief Threatens R&D Cutbacks Unless Ema Retreats on Open Data Plan (Fierce) (Reuters)
  • Guidance on Submission of Single Assessment PSURS Published (EMA)
  • India Upholds Cancellation of Johnson & Johnson Plant License (Pharmalot)
  • Ranbaxy, Another Bad FDA Report & the Missing Generic Diovan (Pharmalot) (Fierce) (Business Standard)
  • Medtech Applauds US/EUTrade Negotiations (Medical Design)
  • Canada Launches official Consultation Documents for Plain Labeling Initiative (Hc) (Hc) (Hc) (Hc)

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  • FDA Reg Change Could Create Opening In Generic Liability Shield (Pink Sheet) (Law 360) (Biocentury)
  • High Court Vacates 2 Pay-For-Delay Rulings Post-Actavis (Law 360)
  • Woodcock Sees Acceleration Of FDA Breakthrough Approvals, Especially In Cancer (Biocentury)
  • FDA Approves Pediatric Indication For Astellas' Mycamine(Micafungin Sodium) For Injection (Astellas)
  • FDA's Guidance To Generic Rivals For Eye Drug Sends Allergan Reeling (Market Watch) (Reuters)
  • Draft Guidance On Asenapine Maleate (FDA)
  • Sandoz Outpaces The Rest Of The Industry With Seven Clinical Trials In The Works (Reuters) (Fierce)
  • Sanofi Plans Late-Stage Diabetes Combo Drug Tests In 2014 (Reuters)
  • FDA-Drug Developer Conundrum: HIV Patients Reluctant To Join Cure Trials (Biocentury)
  • New Entry In The Quest For A Perfect Sleep Drug (Wsj)
  • FDA Approves Pediatric Indication For Astellas' Mycamine (Micafungin Sodium) For Injection (Astellas)
  • FDA Approves ANDA For Taro's Carbamazepine (#201106), Amneal Pharms' Metaxalone (#203399) (FDA)
  • FDA Approves Theravance's NDA For Telavancin (#022407), Supplement For Telavancin Hcl (#022110) (FDA)
  • Sun, Glenmark Nervous System Drug Gets FDA Nod  (Biospectrum)
  • Opinion: FDA Padzur Is Not The Problem, The Randomized Trial Is (Drug Wonks)
  • GSK Reports Remaining Harmony Data For Albiglutide (Biocentury)
  • Who Were The Winners At This Year's Diabetes Meeting? (Fierce)
Pharmaceuticals: General
  • Top Medicare Prescribers Rake In Speaking Fees From Drugmakers (NPR)
  • Not Authorized To Prescribe Drugs? Medicare Pays Anyway (Propublica) (Scrip)
  • Offsetting Effects Of Prescription Drug Use On Medicare's Spending For Medical Services (Cbo)
  • Costs Under Medicare's Prescription Drug Benefit And A Comparison With The Cost Of Drugs Under Medicaid Fee-For-Service (Cbo)
  • Competition And Bids In Medicare's Prescription Drug Program (Cbo)
  • HHS OIG Reports Small Percentage Of Prescribers May Be Over Utilizing Part D Drugs (Policy And Medicine)
Medical Devices
  • Depuy Orthopaedics Wins FDA Approval For Customized Knee Implant System (Mass Device)
  • Infuse Open-Access Project A Model For The Future? Medtronic Thinks So (Pink Sheet)
  • Judge Crushes Medtronic Bone Mill Antitrust Case (Law 360)
  • Medtronic Recalls Intrathecal Catheter Due To Potential For Misalignment And Occlusion (FDA) (FDA) (FDA)  (FDA)
  • Authorizations Of Emergency Use: In Vitro Diagnostic For Detection Of The Novel Avian Influenza A(H7N9) Virus (FDA)
  • Roche Recalls Diagnostic Test On Account Of Potential For Error Message (FDA) (FDA) (FDA)
  • Transcript Of 22 May 2013 Orthopaedic And Rehabilitation Devices Panel (FDA)
Assorted And Government
  • Senate Panel Confirms Regulatory Czar (The Hill)
  • FDA Field Office So Dysfunctional It Needs To Hire Outside Training To Conduct Team-Building Exercises (Fedbizopps)
  • Oxyphen, Phentalene, Phen Fx, And Red Vipers By Beta Labs, Ltd: Recall - Contains DMAA (FDA)
  • More DMAA Products Come Off Market (Ni-Usa)
  • Joint Statement From CBP And Ice In Support Of The Second Joint Strategic Plan For Intellectual Property Enforcement (Customs)
  • KKR To Buy Clinical Trials Firm Pra International (Reuters)
  • H.R.2433 -- Stem Cell Research Advancement Act Of 2013 (Congress)
Upcoming Meetings And Events
  • 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)


  • Sanofi Chief Threatens R&D Cutbacks Unless Ema Retreats On Open Data Plan (Fierce) (Reuters)
  • Guidance On Submission Of Single Assessment PSURS Published (EMA)
  • Early 2014 Hope For EMA Public Hearings (Scrip)
  • St. Jude Lands E.U. Win For Next-Gen Multi-Point Defibrillator (Mass Device) (Mddi) (Medgadget) (St. Jude)
  • Medtech Applauds US/EUTrade Negotiations (Medical Design)
  • Boehringer Follows Bayer, Asks EU Regulator To Approve Wider Use Of Anti-Clotting Drug Pradaxa (Reuters) (Pmlive) (Pharma Letter)
  • Eisai To Suspend Temporarily Commercial Distribution Of Antiepileptic Drug Fycompa In Germany (Eisai) (Pharma Times)
  • NICE: Tamoxifen And Raloxifine Should Be Used On A Preventative Basis By Women Aged 35 And Older With History Of Familial Breast Cancer (Financial Times)
  • New Efpia Chief Viehbacher Calls For Collaboration (Pharma Times)
  • Spain To Guarantee Drug Payments In Centralized Purchases (Bloomberg)


  • India Upholds Cancellation Of Johnson & Johnson Plant License (Pharmalot)
  • Ranbaxy, Another Bad FDA Report & The Missing Generic Diovan (Pharmalot) (Fierce) (Business StANDArd)
  • Edwards Wins Japanese Nod For Next-Gen Sapien Valve (Fierce) (Mass Device)
  • Merck & Co Wins Injunction Against Indian Firm Over Diabetes Drugs (Reuters)
  • MHLW Approves Pfizer's Pneumococcal Vaccine, New H5N1 Influenza Vaccine In Japan (Pharmasia)
  • Indian Experts See Need For HPV Vaccines Amid Screening Constraints (Scrip)

Other International

  • Canada Launches Official Consultation Documents For Plain Labeling Initiative (Hc) (Hc) (Hc) (Hc)

Regulatory Reconnaissance #95 - 25 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

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