Regulatory Focus™ > News Articles > Regulatory Reconnaissance (6 May 2013)

Regulatory Reconnaissance (6 May 2013)

Posted 06 May 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • EU May Implement Device Regulations Sooner Than Planned, Industry Warned (FDA News) ($)
  • Janssen faces suspension in S Korea, recalls drug (BioSpectrum) (Pharmalot) (WSJ) (Fierce Pharma) (Bloomberg)
  • China FDA Reorganizes, Appoints Deputy Commissioners (PharmAsia News) ($)
  • Oxford Works With Drugmakers to Reverse 90% Trial Failure Rate (Bloomberg)
  • Recall of one batch of Panacea vaccine triggers debate on integrity of regulatory officials (PharmaBiz)

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  • Viagra Online: Pfizer To Sell Popular Erectile Dysfunction Pill Directly To Patients On Its Website (AP)
  • FDA Approves Merck's LIPTRUZET (ezetimibe and atorvastatin), a New Product That Can Help Powerfully Lower LDL Cholesterol (Merck) (Forbes) (Forbes) (SCRIP Intelligence) (Reuters) (NYTimes) (Med Page Today) (Cardiovascular Business) (BioCentury) (MNT) (Bloomberg)
  • Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of SUSTIVA (efavirenz) in HIV-1 Infected Pediatric Patients (BMS) (SCRIP Intelligence)
  • Tivozanib Survival Data Go Wrong Way With One-Way Crossover Design (The Pink Sheet) ($)
  • FDA Committee Turns Down AVEO Oncology/Astellas Pharma Inc's Cancer Drug (BioSpace)
  • Aveo's Tivozanib Troubles Reflect Perils Of Ex-U.S. Studies (The Pink Sheet) ($)
  • Lessons For Drug Development From The Aveo Buzzsaw (Xconomy)
  • Melblez ODAC Review May Test The Outer Limits Of Toxicity (The Pink Sheet) ($)
  • First-Cycle Approval Rate Already High; Can PDUFA V Actually Boost It? (The Pink Sheet) ($)
  • FDA panel backs filgrastim as nuke attack countermeasure (SCRIP Intelligence) ($)
  • The Plan B Absurdity: Emergency Contraception Is Treated Like A Drug That Could Be Abused (Forbes)
  • Pay to Prescribe? Two Dozen Doctors Named in Novartis Kickback Case (ProPublica)
  • AMA: Drug company gift reports need physician comments (AMA)
  • Gilead Working 24/7 To Fix Manufacturing Problems In HIV "Complete Response" Letters (The Pink Sheet) ($)
  • Novartis Boost Seen in Fast Approvals as Protection Ends (Bloomberg)
  • Unethical advertising at launch of antidepressants (EurekAlert) (MedIndia)
  • Unmeltable, Uncrushable: The Holy Grail in Painkillers (WSJ)
  • FDA warning against high dose antidepressant prescription may be unwarranted, study finds (EurekAlert) (RTT)
  • California Introduces Biosimilars Bill (Scout)
  • FDA Appeals PLAN B Ruling to the Second Circuit; Exclusivity Decision On One-Step Supplement Could Reignite Simultaneous Rx-OTC Marketing Debate (FDA Law Blog)
  • Merck, Kentucky To Discuss Global Resolution Of Vioxx Consumer Lawsuit (LexisNexis)
  • PhRMA's John Castellani Responds to NYTimes Op-Ed on High Cost of Cancer Medications (NYTimes)
  • PhRMA Wants Medication Adherence Coalition To Address Communication Restrictions (The Pink Sheet) ($)
Medical Devices
  • Dispute Over Who's to Blame for 510(k) Problems Impeding Reform Efforts (FDA News) ($)
  • CDRH Official: Compliance Approach May Need Tweaks, More Flexibility (FDA News) ($)
  • FDA Grants Premarket Approval (PMA) For The SEDASYS® System For Healthy Patients Undergoing Sedation During Routine Colonoscopy And EGD Procedures (J&J) (WSJ) (Reuters)
  • FDA Outlines Next Steps For Online Repository And Standard Elements For Device Labeling (The Gray Sheet) ($)
  • InterValve gets 510(k) clearance for catheter (Cardiovascular Business)
  • FDA intends to award sole source contracts to State Agencies for the inspection of medical devices (FedBizOpps)
  • Medtronic warns, issues recall on wire damage risk with deep-brain stimulation implants (Mass Device) (FDA)
  • FDA Off-Label Citations Disappear In Post-Caronia Enforcement Letters (The Pink Sheet) ($)
  • FDA Risk Communication Panel Critiques MedWatch, And MedWatcher App (The Gray Sheet) ($)
  • NIMH Will Not Use DSM-5 (NIMH) (Scientific American) (MIT Tech Review) (Med City News) (Pharmalot)
  • FDA's Collaboration with Chinese Partners Gets Stronger Each Year (FDA)
  • Chronic Fatigue Meeting Shows Benefits, Hurdles To Patient-Focused Drug Development (The Pink Sheet) ($)
  • How the CIA's Fake Vaccination Campaign Endangers Us All (Scientific American)
  • Op-Ed: To Fight Pandemics, Reward Research (NYTimes)
  • Workers' Exposure Levels To Nanomaterials Recommended, US (MNT)
  • Caffeine-Laced Foods Spur F.D.A. Investigation (FDA)
  • How Can Industry Best Communicate Evidence? (BioCenturyTV)
Conference: FDA in the 21st Century
  • FDA conference at Harvard Law (The Incidental Economist)
  • Keynote: Deborah Autor (Harvard)
  • Peter Barton Hutt's Plenary (Harvard)
  • Plenary 2: Alta Charo on Integrating Speed and Safety (Harvard)
  • Plenary 3: Susan Winckler, President and CEO of FDLI (Harvard)
  • Panel 1: FDA in a Changing World (Harvard)
  • Panel 2: Preserving Public Trust and Demanding Accountability (Harvard)
  • Panel 3: Protecting the Public within Constitutional Limits (Harvard)
  • Panel 4: Timing Is Everything (Harvard)
  • Panel 5: Major Issues in Drug Regulation (Harvard)
  • Panel 6: Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars (Harvard)
  • Panel 7: Major Issues in Device Regulation (Harvard)
  • Panel 8: Food, Supplement, and Tobacco Regulation (Harvard)
  • Panel 9: Addressing the Challenges of and Harnessing New Technologies (Harvard)
Government and Budget
  • Commissioner Hamburg as Congressional Witness: Mixed Success With GOP Thus Far (RPM Report) ($)
  • Presentation on FDA's Buget by its COO and CFO (FDA)
  • The Implications of the Budget Control Act on FDA Funding (Alliance for a Stronger FDA)
  • Zients steps down as OMB deputy director (Federal Times)
  • Vacancies, furloughs piling up at OMB (The Hill)
  • Reps. Upton, Coburn Urge Hamburg to Require Other Painkillers to be Abuse-Resistant as Well (E&C)
  •  Biopharma among targets for trade secret theft, USTR says (SCRIP Intelligence)
Upcoming Meetings and Events
  • 8-9 May 213: Summit on Color in Medical Imaging (FDA)
  • 8 May 2013: Vaccines and Related Biological Products Advisory Committee (FDA)
  • 8 May 2013: Intelligence Squared Debate: Is FDA's Caution Harzardous to our Health? (IQ2)
  • 9 May 2013: Senate HELP Committee Hearing on Pharmaceutical Compounding and its Proposed Legislative Solution (Senate)
  • 9 May 2013: FDA Listening Tour on Antibiotic Resistance (FDA)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • 17 May 2013: NCATS Meeting (NCATS)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • EU May Implement Device Regulations Sooner Than Planned, Industry Warned (FDA News) ($)
  • China FDA Reorganizes, Appoints Deputy Commissioners (PharmAsia News) ($)
  • Oxford Works With Drugmakers to Reverse 90% Trial Failure Rate (Bloomberg)
  • Recall of one batch of Panacea vaccine triggers debate on integrity of regulatory officials (PharmaBiz)
  • India regulators pull J&J plant license on baby powder concerns (Reuters)
  • India's U.S. Drug Rulings Earn Trade Blacklist Spot From Obama Administration (Huffington Post)
  • Janssen faces suspension in S Korea, recalls drug (BioSpectrum) (Pharmalot) (WSJ) (Fierce Pharma) (Bloomberg)
  • Indian panel wants Health Ministry to decide banning Analgin in a month (PharmaBiz)
  • India's govt says nine cases of irregularities in clinical trials during the last three years (PharmaBiz)
  • India's Clinical trials industry witnessing downtrend in India: Dr C Raghu (PharmaBiz)
  • Undermining the regulation of stem cell therapies in Italy: A warning for the future? (Science-Based Medicine)

General Regulatory and Interesting Articles

  • It's smaller than a fingernail, but this needle- free Nanopatch could be the future of vaccines (Med City News)
  • Implantable blood-test-on-a-chip sends continuous readings to a cellphone (Med City news)
  • Drug Assay Numbers, All Over the Place (In The Pipeline)

Regulatory Reconnaissance #60 - 6 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

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