Regulatory Reconnaissance (22 May 2013)

Posted 22 May 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

In Focus: International

Comments? Suggestions? Email me at


  • Ranbaxy Whistleblower: So Many Infractions And Each Was Egregious (Pharmalot)
  • U.S. government taps GlaxoSmithKline for new antibiotics (Reuters) (Bloomberg)
  • FDA Posts 483s for St. Jude Medical (FDA)
  • Pfizer's effort to confront shortage leads to second Levoxyl recall (Fierce Pharma Manufacturing)
  • Boehringer Ingelheim responds to FDA warning letter (BI)
  • FDA Denies Deston's Petition to Market Ear Infection Drug (FDA News)
  • FDA is Asked to Deviate From ANDA "Exception Excipient" Policy for Generic VFEND Injection; Precedent Indicates Agency Will Remain Firm (FDA Law Blog)
  • Regeneron, Sanofi asthma drug seen as potential game changer (Reuters)
  • FDA Public Workshop: Clinical Trial Design Issues - Drug & Device Development for Localized Prostate Cancer (FDA)
  • FDA Public Workshop: Clinical Trial Design Issues - Development of New Therapies for Non-Muscle Invasive Bladder Cancer (FDA)
  • Final Phase III data support AcelRx pain drug/device (SCRIP Intelligence) (Reuters)
  • B-I Posts PhIII Results for Respimat Inhaler (Business Wire)
  • Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients (J&J)
  • Perosphere Receives FDA IND Clearance to Initiate Clinical Investigations of the Safety and Efficacy of PER977 to Reverse the Activity of Anticoagulation Therapies including Factor Xa- and IIa-Inhibitors (Business Wire)
  • Novartis Ramps Up Alzheimer's Drug Pursuit as Rivals Fail (Bloomberg)
Medical Devices
  • Accuracy of Blood Glucose Meters Draws FDA Scrutiny (KHN) (Medical Daily)
  • Law Firm: FDA's Authority to Rescind 510(k) "Not Settled" (King & Spalding)
  • Medtronic Pacemaker Case Dismissed With Prejudice; No Duty To Warn Patient (Lexis Nexis)
  • Bausch + Lomb Receives FDA Approval for the TRULIGN™ Toric Posterior Chamber Intraocular Lens (PR Newswire) (Mass Device)
  • Hologic Receives FDA Approval for a New Low-dose 3D Mammography (Breast Tomosynthesis) Solution for Breast Cancer Screening (Hologic) (Mass Device)
  • Intuitive Robotic Surgery Case Goes to Seattle-Area Jury (Bloomberg)
  • FDA Endorses Agile: What Does that Mean? (MDDI)
  • US FDA to Require Proof of IEC 60601-1 3rd Edition in Summer 2013 (Emergo Group)
  • BioElectronics Petitions FDA Reclassification Panel to Make Device OTC (PR Newswire)
  • Covidien Announces Clinical Trial Data Showing Endoscopic Ablation Therapy Eliminates Precancerous Esophageal Tissue and Significantly Reduces Disease Progression (Business Wire)
Assorted and Government
  • Do Companies Have a Duty To Mine FDA's Data? (Law 360)
  • FDA Posts New Batch of Warning Letters (FDA)
  • Patent-Protected Technology Ended Up on FDA Website, Companies Charge (Food Safety News)
  • FDA to Hold Science Board Meeting via Teleconference (FDA)
  • US-based Regulatory Intelligence Firm Graematter Closes $835,000 Seed Round (St. Louis Business Journal)
  • FDA's Social Media Messages Should Be Pretested, Risk Communication Advisors Say (The Pink Sheet)
  • J&J's Alex Gorksy Asks Employees To Assess Its Battered Corporate Credo, Re-Commit to Quality (Pharmalot)
  • Jerome "The Bus" Bettis Promotes Auvi-Q With and Without the Important Safety Information (Pharma Marketing Blog)
  • Are regulatory and legal teams limiting digital marketing? (World of DTC Marketing)
  • VanRoekel to lead OMB's management team (Federal Times) (The Hill) (Murray)
  • Physician Payment Sunshine Act: 62% of Companies are Capturing Aggregate Spend Information (Policy and Medicine)
  • Physician Payment Sunshine Act: Fraud and Abuse Implications of Sunshine (Policy and Medicine)
  • MedWatch's Patient-friendly Reporting Form Might Need An Overhaul (The Pink Sheet)
  • Biotech Exec Indicted On Charges He Stole Investor Funds (Law 360) (DOJ)
  • Nutrition 21 gets NDI for arginine silicate ingredient (Nutra Ingredients USA)
Upcoming Meetings and Events
  • 21 May 2013: First-Ever Patient Network Town Hall (FDA)
  • 21-22 May 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 22 May 2013: Markup of Senate Compounding, Track and Trace Legislation (HELP)
  • 22 May 2013: Congressional Hearing: "Food and Drug Safety, Public Health, and the Environment in China" (CECC)
  • 22 May 2013: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
  • 22 May 2013: CVM's New Animal Drugs for Use in Feeds Workshop (FDA)
  • 23 May 2013: Energy and Commerce Committee Hearting, "Examining Drug Compounding" (E&C) (Janet Woodcock to Testify)
  • 23 May 2013: Reagan-Udall Foundation Annual Open Public Meeting (RU)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • India to Require Clinical Trials to Obtain Consent on Camera (The Times of India)
  • India Orders Own Probe Of Ranbaxy's Approved Drugs Backgrounds (PharmAsia News)
  • Indian Govt probed US FDA charges on Ranbaxy in 2008, but didn't ban it (India Times)
  • NICE rejects Avastin for ovarian cancer, but backs Lucentis for RVO (The Pharma Letter) (SCRIP Intelligence) (Pharma Times) (PMLive) (PMLive)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2013 (EMA)
  • Italy Clarifies Differences Between GMP, GLP and GCP (AIFA)
  • Amag investigates anemia drug after report of death in Switzerland (Reuters)
  • NICE must have access to evidence for pharma licensing decisions, says NAO (Pharma Times)
  • CFDA Announces Overall Plans For Staffing, Internal Structures, Duties (PharmAsia News)
  • UK Watchdog Bans 'Misleading' Listerine Mouthwash Dental Health Advert (Huffington Post)
  • Brazilian importers fight key disclosure rule (Clinica)
  • Pace of drug approvals to moderate for global pharma companies, says Fitch Ratings (The Pharma Letter)
  • Ranbaxy episode to hit drugs carrying 'India' label; tough to secure new contracts (India Times)
  • German cops seize Boston Scientific stents in cutthroat patent fight (Fierce Medical Devices)
  • EMA Reviewing Safety of Dual RAS Blockade for Hypertension, HF (Medscape)
  • Three Canadian Companies Recall All Lots of Quetiapine (Medscape)
  • No plans to change Ranbaxy's name, says Daiichi Sankyo (India Times)
  • Baxter Receives Marketing Authorization for HyQvia in European Union (Business Wire) (BioCentury)
  • European Medicines Agency Validates Gilead's Marketing Application for Sofosbuvir for the Treatment of Hepatitis C (Business Wire) (BioCentury)
  • Track & Trace: EDQM is Making Progress Towards the Implementation of eTACT (ECA)
  • ABPI to represent vaccine industry (Pharma Times)
  • CFDA Announces Schedule For E-Monitoring Of New EDL Drugs (PharmAsia News)
  • India Cancels Plan Of Free Generics At Hospitals, Health Centers (PharmAsia News)
  • NHS chief to retire - but not until next year (Pharma Times) (PMLive)
  • Abbott Announces CE Mark for World's Longest Coronary Drug Eluting Stent (Abbott) (Fierce Medical Devices)
  • Medtronic Announces CE Mark and Launch for CapSureFix Novus(TM) 5076 MRI Lead (Boardvote) (MedGadget)
  • EMA accepts MAA for LCP-Tacro (BioCentury)
  • France launches rare disease fund (BioCentury)
  • Teva Bets on Reformulating Old Drugs as Investors Say 'Show Me' (Bloomberg)
  • Syria pharmaceutical production slashed by war (AFP)
  • Boston Scientific competitor calls the cops to seize 'illegal' stents in Germany (Boston Biz Journal)
  • Rwandan health minister hits back at critics of drug company deal (The Guardian)
  • Chinese drugmaker fights counterfeiting in Africa with SMS technology (Fierce Pharma Manufacturing)
  • Will U.K. watchdogs change their minds on Avastin in ovarian cancer? (Fierce Pharma)

General Regulatory and Interesting Articles

  • Many mental-illness websites show drug-company bias, study finds (Minneapolis Post)
  • Drug Side Effects May Be Inevitable (MNT)
  • Clinicians often poor at predicting medication adherence (Modern Healthcare)
  • Doctors prescribe more analgesics to women than to men just for being female (EurekAlert)
  • Can Statins Cut the Benefits of Exercise? (NYTimes)
  • Unexcited? There May Be a Pill for That. (NYTimes)
  • COPD patients' CV risk increased with beta-agonists and anticholinergics (RPS)
  • Pain Relievers Do Not Cause Asthma, Study Finds (NYTimes)
  • Analog Sensor-Based Medical Devices Resilient, but Show Some Weakness to Radio Frequency Hacking (VIDEO) (MedGadget)
  • Why Investing In Smarter Pill Bottles Could Help Us Save Billions Of Dollars In Health Costs (Think Progress)
  • Wireless Pill Bottle Wins Healthcare Innovation World Cup (BI)
  • A brief history of America's fluoride wars (Washington Post)

Regulatory Reconnaissance #72 - 22 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.

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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles