Regulatory Reconnaissance (1 July 2013)

Posted 01 July 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

In Focus: International

  • 'Biosimilar' Drug Ruling to Hit Big Pharma (FT) (Market Watch)
  • EU Regulators Dishing out Fewer CE Marks, Study Finds (Mass Device)
  • Industry: Tightening EU Device Regulations Will Strangle Business (Fierce)
  • EU At Crossroads on New Medical Devices Legislation (EurActiv)
  • Europe's CHMP Recommends 10 Drugs in One Week (Fierce) (EMA)
  • EU Industry: New Phv Fee Plan Better, but Still Room for Improvement (SCRIP)
  • India to Increase Drug Inspection Staff 10-Fold (India Times)
  • DCGI Rule to Require Companies to Disclose International Regulatory Actions (India Times) (SCRIP)

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  • FDA Approves a Drug for Hot Flashes (Noven) (FDA) (NYTimes) (Fierce) (SCRIP) (WSJ) (BioCentury) (Pharma Letter) (Pharma Times)
  • FDA sends J&J CRL on Xarelto for stent thrombosis (Bayer) (Fierce) (Pink Sheet) (SCRIP) (Forbes) (Pharma Letter)
  • Extensively Marked-Up Compounding and Track and Trace Bill Emerges from Senate (Congress)
  • Key Decision By European Drug Regulators on Remicade Is Unlikely To Spark American FDA (Forbes)
  • New labels tied to fewer child poisonings by OTC meds (Reuters)
  • FDA Envisions Flexible Approach To Expanded Use Of Accelerated Approval (Pink Sheet)
  • How Should FDA Name Biosimilar Products? (RPM Report)
  • No FDA nod, Indian Generics Co. Caraco may miss exclusivity for diabetes drug (Business Standard)
  • Sunovion Pharmaceuticals Inc. Announces FDA Approval of Latuda (lurasidone HCl) as Monotherapy and Adjunctive Therapy in Adult Patients with Bipolar Depression (Sunovion)
  • Bayer Submits Sorafenib (Nexavar) to the EMA and FDA for the Treatment of Thyroid Cancer (Bayer) (Pharma Letter)
  • NYTimes: Mutual Pharmaceuticals Vs. Bartlett Leaves Consumers With Little Recourse (NYTimes)
  • OGD Will First Review DMFs That Are Already Referenced in ANDAs to Manage Heavy Workload (Pink Sheet)
  • Compounding Animal Drugs from Bulk Ingredients: Not Prohibited by Federal Food Drug and Cosmetic Act, Affirmed as Recently as 2011 (McGuire Woods)
  • FDA Approves ANDAs for UCLA Biomedical's Fludeoxyglucose F18 (#203811) and Ammonia N 13 (#203812) (FDA)
  • FDA Approves Merz Pharmaceuticals' Naftin (Naftine Hydrochloride) (#204286) (FDA)
  • New FDA rule to target drug shortages (Boston Herald)
  • FDA Gears up to Hire More Staff Under GDUFA Authority (FDA)
  • Resurrected Flibanserin Filing Tests FDA Position On Female Sexual Desire Disorders (Pharmaceutical Approvals Monthly)
  • Biomarker Approvals At Pre-IND Stage Requested For Orphan Drugs (Pink Sheet)
  • Mini-Sentinel Funding Raised To $135 Mil. To Support Larger-Than-Expected Data Resource (Pink Sheet)
  • NCATS May Consider Requesting "Active" Compounds For Repurposing Program (Pink Sheet)
  • FDA Seeks Alternatives To QT Interval For Assessing Risk Of Torsade de Pointes (Pink Sheet)
  • FDA Outlines Plans to Use Quality Metrics for Surveillance of Manufacturers (Gold Sheet)
  • Fresenius Kabi USA Issues Voluntary Nationwide Recall of Benztropine Mesylate Injection, USP 2 mg/2 mL (1 mg/mL), in 2 mL Single Dose Vials (Fresenius)
  • Court Urged To Find Preemption Of Punitive Damages Awards In Failure-To-Warn Suits Involving Prescription Drugs (WLF)
  • Merck, BMS Target Cipla USA Over Generic HIV Drug Sustiva (Law 360)
  • Cangene pulls Factor IX MAA (SCRIP)
  • Latest BioCentury TV Episode on Breakthrough Drugs (BioCentury)
  • Roche's Elquis as Effective as Warfarin in Large Clinical Trial (Reuters) (BMS)
  • TransTech Pharma Completes End of Phase 2 Meeting with FDA for TTP488 (TransTech)
  • Clean Room Lessons from FDA's Compounding Pharmacy Inspections (Gold Sheet)
Pharmaceuticals: General
  • An Orphan Jackpot: Why Orphan Drug Regulations are 'Out of Whack' (NYTimes)
  • Questions about effect of over-the-counter Plan B for all ages (Washington Post)
  • Does Medication Waste Cost The U.S. $418 Billion? (Forbes)
  • Drugmakers Should Not Decide Study Disputes In Court (Forbes)
  • AmpliPhi Signs Global R&D Agreement with US Army to Develop Bacteriophage Therapies to Treat Resistant Bacterial Infections (AmpliPhi)
  • GAO Report on the Highest-Expenditure Part B Drugs (GAO)
  • Health Subcommittee Examines Proposals for Reform and Improvement of the Medicare Part B Drug Program (E&C)
  • As U.S. Drug Prices Soar, Americans Resort To Risky Foreign Online Pharmacies (Think Progress)
  • Cancer care: Are new treatments the end of chemotherapy? (CBS)
Medical Devices
  • FDA will play major role in HIT regulation, doc warns (Modern Healthcare)
  • FDA's Device Labeling Proposed Rule Misses The Mark, Industry Says (Gray Sheet) (FDA Docket)
  • Medtronic Recalls Sutureless Connector Intrathecal Catheter Products Due to Catheter Occlusion (FDA) (FDA) (FDA)
  • FDA Seeks Input On Computer Modeling Library For Device Development (Gray Sheet)
  • mHealth regs spark debate (GovHealth IT)
  • Roche Diagnostics scores another FDA victory (Fierce)
  • AngioDynamics wins clearances in the U.S., Canada (Mass Device)
  • Scientists Back Alzheimer's Test Amid Doubts Over Value (Bloomberg)
  • Double trouble: Medtronic, Intuitive Under FDA's Microscope (Medical Device Daily)
  • FDA Panel Recommends Upclassification of Blood Lancets (Gray Sheet)
  • CDRH Launches 'Health Of Women' Program; Research Agenda To Focus On Ortho, Cardio Devices (Gray Sheet)
  • Medtech M&A advisor warns of longterm consequences of SCOTUS Myriad decision (MedCity News)
  • Medtronic Hit With Shareholder Suit Over Infuse Studies (Law 360)
  • Diabetes: The Path To An Artificial Pancreas Looks A Little More Reasonable (Mass Device)
  • FDA Posts Transcript of Orthopaedic and Rehabilitation Devices Panel from 21 May 2013 (FDA)
Assorted And Government
  • Breaking the Seal on Drug Research (NYTimes) (Opp: Drug Wonks)
  • Why the Farm Bill May Impact the FDA Budget (Strengthen FDA)
  • Science Board Investigates How FDA Has Responded To Critical 2007 Report (Gray Sheet)
  • FDA Congressional Advocacy at a Glance (Strengthen FDA)
  • US Capitol Capsule: Driving 'bad guys' out: A burden for industry, not taxpayers (SCRIP)
  • Lawmakers push to free small businesses from costly regs (The Hill)
  • Groups press new regs czar to dislodge stalled rules (The Hill)
Upcoming Meetings And Events
  • 2 July 2013: FDA Webinar on FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • 'Biosimilar' drug ruling to hit Big Pharma (FT) (Market Watch)
  • E.U. regulators dishing out fewer CE Marks, study finds (Mass Device)
  • Industry: Tightening EU device regs will strangle business (Fierce)
  • EU at crossroads on new medical devices legislation (EurActiv)
  • Europe's CHMP recommends 10 drugs in 1 week (Fierce) (EMA)
  • EU industry: new PhV fee plan better, but still room for improvement (SCRIP)
  • Drug Shortages Feared as Deadline Looms for Approval to Export APIs to Europe (Gold Sheet)
  • Draft guideline on adjustment for baseline covariates (EMA)
  • UK Lords: 'Simplify pharma regulation' (PMLive)
  • Teva says cleared of wrongdoing after man's death in France (Reuters)
  • A call for harmony on clinical trials (Pharmafile)
  • EC Appoints Patients Representatives to EMA's Committee for Advanced Therapies (EC)
  • CHMP recommends EU approval of Roche's Subcutaneous Herceptin for HER2 positive breast cancer (Roche) (Reuters) (BioCentury)
  • Bayer's Regorafenib Recommended for Approval in the European Union for the Treatment of Metastatic Colorectal Cancer (Bayer) (SCRIP)
  • CHMP backs Stivarga, Provenge (BioCentury)
  • Europe gives Sanofi's MS drugs big push (Fierce) (Reuters)
  • EMA recommends approval of GSK's Tafinlar for the treatment of metastatic melanoma (EMA)
  • Dendreon's Provenge gets recommendation in Europe (Fierce) (Dendreon) (EMA)
  • PRAC issues new safety warning for diclofenac (SCRIP)
  • European regulators smile on small biotech Halozyme, and shares soar (Market Watch)
  • CHMP backs Raptor's Procysbi (BioCentury) (MNT) (Reuters)
  • Genzyme Receives Positive CHMP Opinion for LEMTRADA™ (alemtuzumab) in Europe (Genzyme)
  • NICE sticks with no for Cell Therapeutics' Pixuvri (SCRIP)
  • Omontys cloud darkens as Takeda pulls EU application (SCRIP)
  • CHMP Recommends New restrictions on use of medicines containing ergot derivatives (EMA)
  • GSK's personalised skin cancer drug Tafinlar set for European approval (PMLive)
  • Restrictions on use of codeine for pain relief in children - CMDh endorses PRAC recommendation (EMA)
  • New safety advice for diclofenac - CMDh endorses PRAC recommendation (EMA)
  • New recommendations to manage risk of allergic reactions with intravenous iron-containing medicines (EMA)
  • Teva Sues Reckitt Over UK Generic-Drug Delay Tactics (Law 360)
  • Dompé Announces the EMA Has Granted Orphan Drug Designation to Its rhNGF-Based Treatment for Retinitis Pigmentosa (Dompe)
  • European sports nutrition sector calls for end to 'decade-long regulatory limbo' (Nutra Ingredients)


  • India to increase drug inspection staff by 10 fold (India Times)
  • DCGI Rule to Require Companies to Disclose International Regulatory Actions (India Times) (SCRIP)
  • India's Abrupt Ban On Pioglitazone Angers Industry, Medical Experts; Is A Rollback In The Cards? (PharmAsia) (PharmaBiz)
  • Sanofi wins Japanese approval for diabetes drug Lyxumia (PMLive) (SCRIP)
  • China Probes U.K. Pharmaceutical Firm GlaxoSmithKline After Corruption Claims Aired (Forbes)
  • St Jude joins Medtronic with Japanese MRI-safe pacemaker approval (Clinica)
  • Chugai gains Japanese approval for Perjeta and Bonviva (Pharma Letter) (BioCentury)
  • Kyowa seeking Japanese approval of pegfilgrastim (BioCentury)
  • IPC to submit new ADR report on several drugs to DCGI soon (PharmaBiz)

Other International

  • First nationally-consistent list of hospital medicines takes effect in New Zealand (Pharma Letter)
  • Syria's $620 Million Pharma Market Nearly Destroyed By Ongoing War (PharmAsia)
  • Start treating HIV sooner, WHO says (AP)

General Regulatory And Interesting Articles

  • Bayer Celebrates 150 Year Anniversary (Bayer)
  • Would it be evil to build a functional brain inside a computer? (io9)
  • Lab animal wars: Scientists blast living conditions of stolen mouse models (Fierce)

Regulatory Reconnaissance #99 - 1 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

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