Regulatory Focus™ > News Articles > Regulatory Reconnaissance (31 May 2013)

Regulatory Reconnaissance (31 May 2013)

Posted 31 May 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • Canada's Soon-to-Launch Clinical Trials Database: How Does it Measure Up? (Maclean's)
  • B.C. Government Denies Drug Approval Conspiracy (The Vancouver Sun)
  • EMA Calls for Curbs on GSK, Valeant Epilepsy Drug (Reuters) (EMA)
  • France Withdraws Approval for Vidora 25 mg due to Questionable Efficacy, Data (ANSM)
  • Oral Almitrine to be Withdrawn by EU Member States (EMA)

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  • Two FDA Officials Quarrel Over Safety Of Angiotensin Receptor Blockers (Forbes) (WSJ)
  • FDA Office That Guided PDUFA V Gets New Name Highlighting Its Strategic Role (The Pink Sheet) (FDA News)
  • FDA approves two drugs, companion diagnostic test for advanced skin cancer (29 May) (FDA) (GSK)
  • FDA Approvals Outpacing Last Year (Reuters)
  • A Lone Voice Raises Alarms on Safety of Diabetes Drugs (NYTimes)
  • FDA denies approval to Endo Health's testosterone drug (Reuters) (Endo) (The Pharma Letter) (BioCentury) (SCRIP Intelligence) (Pharma Times)
  • Another Day, Another Warning Letter For Hospira, But Will The FDA Issue A Consent Decree? (Forbes)
  • FDA Five Year Plan on Risk Benefits Framework (Policy and Medicine)
  • Manufacturers Seek Strategies for Life-Cycle Approach to Process Validation (PharmTech Talk)
  • Track and Trace Legislation: What It Is, and How to Prepare (Becker's Hospital Review) (Bloomberg)
  • Lilly Tries to Block Generic Axiron (DD&D)
  • FDA Approves ANDA for Tris Pharma's Dextroamphetamine (#203644) (FDA)
  • Takeda Sues 3 Rivals Over Planned Heartburn Drug Generics (Law 360)
  • Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind (PR Newswire)
  • Teva Announces FDA Acceptance of sNDA for a Higher Concentration Dose of COPAXONE Given Three Times a Week (Business Wire)
  • FDA Warns Pregnant Women Magnesium Sulfate Could Cause Bone Abnormalities In Babies (FDA) (Medical Daily)
  • FDA Lifts Clinical Hold On PharmAthene's SparVax® Anthrax Vaccine Program (Boardvote) (SCRIP Intelligence)
  • BioMarin's Vimizim under review in U.S., EU (BioCentury) (SCRIP Intelligence)
  • The FDA Doubles Down On Its Plan B Troubles (CPR Blog)
  • Gilead Form 483 Provides Insight into FDA's Rejection of HIV Drugs (FDA) (FDA News)
  • FDA Announces Data Quality Webinar Related to 2008 ADUFA Reauthorization (FDA)
  • California Biomedical Industry Leaders Urge Congress to Take Action on FDA User Fees for FY2014 (PR Web)
  • Exelixis Initiates Phase 3 Pivotal Trial of Cabozantinib in Patients With Metastatic Renal Cell Carcinoma (Business Wire)
  • Alkermes Unveils Full Mid-Stage Data On Depression Drug (Xconomy)
Medical Devices
  • The uChek App-the Target of a Recent FDA Letter-Is Currently FDA Registered as Class I Device (Mobi Health News)
  • FDA's Regulation of Mobile Medical Apps Will Probably Confuse You (MDDI)
  • 3M Prepared as Final Two CFC-Based Inhalers to be Phased Out (In-Pharma Technologist)
  • The Problem with Compliance-First Design Strategies (Manufacturing Geek)
  • Medtronic's Endurant II aneurysm stent graft win FDA approval (Mass Device) (Cardiovascular Business) (Boardvote)
  • Hansen gains on FDA nod for heart rhythm trial (Mass Device)
  • FDA Approves Breathe Technologies' Lighter Sleep Apnea CPAP Device [VIDEO] (Medical Daily)
  • GE Healthcare Announces 510(k) Clearance of New Brivo Plus C-arm for the US (Business Wire)
  • FDA warns CooperSurgical about Texas manufacturing plant (Mass Device)
  • iTClamp Hemorrhage Control System for Severe Wounds FDA Approved (VIDEO) (MedGadget)
  • Amusing: Masimo Renews $1,000,000 Guarantee that Masimo SET® Will Outperform All Covidien Nellcor™ Pulse Oximeters (Boardvote)
Assorted and Government
  • FDA Should Plan for up to 10% Cut in FY2015, OMB SaysFederal Times)
  • Enforcement Report - Week of May 29, 2013 (FDA)
  • Regulatory: Deciding whether to voluntarily disclose a potential FCPA violation (Inside Counsel)
  • Weeding out Regulatory Duplication (AAF)
  • Cancer Drug Prices Increase Dramatically. Is the Sky the Limit? (Nature)
  • S.1013 -- Patent Abuse Reduction Act of 2013 (Congress)
  •  S.1029 -- Regulatory Accountability Act of 2013 (Congress)
  • H.R.2135 -- Cardiac Arrest Survival Act of 2013 (Congress)
Upcoming Meetings and Events
  • 29-30 May 2013: Medical Countermeasure Regulatory Science Symposium (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • Canada's soon-to-launch clinical trials database: how does it measure up? (Maclean's)
  • B.C. government denies drug conspiracy (The Vancouver Sun)
  • EU agency calls for curbs on GSK, Valeant epilepsy drug (Reuters) (EMA)
  • France Withdraws Approval for Vidora 25 mg due to Questionable Efficacy, Data (ANSM)
  • Oral almitrine to be withdrawn by EU Member States (EMA)
  • Celgene Receives Positive CHMP Opinion for Oral Anti-Cancer Therapy Pomalidomide as Treatment for Patients with Relapsed and Refractory Multiple Myeloma (Business Wire)
  • WHO issues draft guidance on good pharmacopoeial practices, seeks industry views (PharmaBiz)
  • Lucentis rival Eylea one step away from NHS approval (Pharma Times) (PMLive) (BioCentury) (BioCentury) (Reuters)
  • CFDA Wants To Speed Up Timeframe For E-Monitoring Of Sterile Drugs (PharmAsia News)
  • ENVI's 29 may debate on medical devices (Med Devices Legal)
  • Japanese drugmakers open 'libraries' in $100 million health project (Reuters)
  • Novo files for EU approval of Tresiba/ Victoza combination in diabetes (PMLive) (The Pharma Letter)
  • Polarized Reactions to the Draft Revisions of the Declaration of Helsinki (The Lancet)
  • First biosimilar filgrastims launched in Japan (SCRIP Intelligence)
  • Submissions received: Joint TGA and Medsafe project: Trans-Tasman early warning system of safety concerns with medicines and medical devices (TGA)

General Regulatory and Interesting Articles

  • Some common prescriptions linked to impotence (Reuters)

Regulatory Reconnaissance #78 - 31 May 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.

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