Regulatory Focus™ > News Articles > Regulatory Reconnaissance (20 June 2013)

Regulatory Reconnaissance (20 June 2013)

Posted 20 June 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Plan B Saga Exposes FDA To Drug-Approval Suits (Law 360)
  • Senate passes bill aimed at ensuring flu vaccine availability (The Hill)
  • FDA Expanding Role of Office of Criminal Investigations (Policy and Medicine)
  • Finding opportunity in FDA focus on drugged driving (MM&M)
  • No More Secrets: Medtronic Shows How Open Science Might Work In the Real World (Forbes)
  • Sarepta's Eteplirsen Walk-A-Thon Now Stretches For 84 Weeks (The Street) (Fierce) (SCRIP)
  • Advisory committee planned for Vascepa sNDA (BioCentury)  (The Street) (Pink Sheet)

In Focus: International

  • EU Risks Drug Shortages If API Import Regs Not Waived for US Says SOCMA (In-Pharma Technologist)
  • EU pharmacovigilance fee proposal trumps agency remuneration puzzle (SCRIP)
  • Total Recall? China Chastises J&J Over Its Product Recall Policy (Pharmalot)
  • Clinical Trial Policies Top IP As Biggest Obstacle To Indian Innovation (PharmAsia)
  • Daiichi seeking Japanese approval of pandemic flu vaccine (BioCentury) (SCRIP)
  • CISCRP survey finds improved perceptions of clinical trials (Pharma Times)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • Sarepta's Eteplirsen Walk-A-Thon Now Stretches For 84 Weeks (The Street) (Fierce) (SCRIP)
  • Plan B Saga Exposes FDA To Drug-Approval Suits (Law 360)
  • Priority Review for Paladin's leishmaniasis compound (BioCentury)
  • Advisory committee planned for Vascepa sNDA (BioCentury)  (The Street) (Pink Sheet)
  • Senate passes bill aimed at ensuring flu vaccine availability (The Hill)
  • ANDA Stability Final Guidance Arrives, But Offers Few Answers for Industry (Pink Sheet)
  • Sens. Say Pay-For-Delay Legislation Still Needed (Law 360)
  • FDA Releases Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations (FDA)
  • Finding opportunity in FDA focus on drugged driving (MM&M)
  • Report: Use prescription meds properly, save $200 billion a year (Fierce) (Elsevier) (MedCity News) (Kaiser)
  • Durect Announces FDA Acceptance of NDA Submission for POSIDUR (SABER-Bupivacaine) (PR Newswire)
  • Vivus rises on faster functioning ED drug, not obesity news (SCRIP)
  • Efforts to Restrict Plan B Move to State Level (Think Progress)
  • Advance Pharmaceutical Inc. Issues Voluntary Recall of One Lot of Enteric Coated Aspirin Tablets, 81 mg, Due to Health Risk (FDA) (FDA)
  • Is J&J CEO Alex Gorsky confident manufacturing problems are solved at McNeil Consumer Healthcare? (Philly Pharma)
  • J&J, Pharmacyclics' ibrutinib extends lives in cancer studies (SCRIP)
  • Naloxone Could Go OTC (Elsevier)
Pharmaceuticals: General
  • Study Finds Sharp Drop in HPV Infections in Girls After Introduction of Vaccines (NYTimes) (SCRIP)
  • Mississippi AG Hood Will Subpoena Google on Drug Sales (PharmPro)
  • Nearly 7 in 10 Americans are on prescription drugs, Mayo Clinic study finds (EurekAlert) (ICT)
  • PhRMA talks up role in policy and research (Politico)
  • Inspector General Faults Medicare for Not Tracking 'Extreme' Prescribers (ProPublica)
  • Senators Introduce Bill To Establish Public Medicare Claims Database (Gray Sheet)
  • You Just Won... Lilly Fights Scam Artists Over Use Of Its Name (Pharmalot)
Medical Devices
  • No More Secrets: Medtronic Shows How Open Science Might Work In The Real World (Forbes)
  • The Hackers are Coming! (FDA Law Blog)
  • Abyrx gets an FDA green light for its absorbable bone putty (Mass Device)
  • FDA clears OrthoSensor's Verasense knee replacement device (Mass Device)
  • CryoLife eyes FDA approval for dissolving hemostat (Fierce) (CryoLife)
  • ICD Not to Blame for Higher CV Mortality After Shock (MedPage Today)
  • Beckman Coulter Announces FDA Clearance of New Access AccuTnI+3 Troponin I Assay for the Access 2 Immunoassay System (Beckman)
  • The Myriad Ruling: Six Points Every Biotech CEO Must Consider (PharmExec)
  • OrthoSensor wins FDA nod for knee tech (Fierce)
  • NanoKnife for Electric Execution of Tumors Gets FDA Approval for IDE Study (MedGadget)
Assorted and Government
Upcoming Meetings and Events
  • 17 June 2013: FDA Basics Webinar: Biological Products: Part 1 (FDA)
  • 18 June 2013: Understanding the Regulatory Landscape for Adaptive Design Trials (RAPS)
  • 18 June: NCATS to announce awards for Discovering New Therapeutic Uses for Existing Molecules program (NCATS)
  • 18 June 2013: Continuing Concerns Over BioWatch and the Surveillance of Bioterrorism (House)
  • 18 June 2013: Appropriations Committee Hearing on FDA (Senate)
  • 19-20 June 2013: Regulatory Education for Industry (REdI) Conference (FDA)
  • 21 June 2013: Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives Part 15 Public Meeting (FDA)
  • 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)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

Europe

  • EU Risks Drug Shortages If API Import Regs Not Waived for US Says SOCMA (In-Pharma Technologist)
  • EU pharmacovigilance fee proposal trumps agency remuneration puzzle (SCRIP)
  • MHRA Public Consultation on Transposing the Falsified Medicines Directive into UK legislation (MHRA)
  • ArtVentive Medical wins CE Mark for peripheral catheter (Mass Device)
  • Medical Device Alert: Implantable drug pumps and accessories manufactured by Medtronic (MDA/2013/042) (MHRA)

Asia

  • Total Recall? China Chastises J&J Over Its Product Recall Policy (Pharmalot)
  • Clinical Trial Policies Top IP As Biggest Obstacle To Indian Innovation (PharmAsia)
  • Daiichi seeking Japanese approval of pandemic flu vaccine (BioCentury) (SCRIP)
  • Another month, another gliflozin filing in Japan (SCRIP)
  • CFDA Orders Hong Kong Suspension Of Cold Pill To Test For Banned Drug (PharmAsia)

General Regulatory and Interesting Articles

  • Moscamed Launches Urban Scale Project Using Oxitec GM Mosquitoes in Battle Against Dengue (PR Newswire)
  • CISCRP survey finds improved perceptions of clinical trials (Pharma Times)
  • Regulatory: The dos and don'ts of internal investigations-Part 4 (Inside Counsel)
  • Could Combining Silver Particles With Old Antibiotics Help Treat Drug-Resistant Infections? (EurekAlert)
  • New Middle East virus spread in hospitals (NBC)

Regulatory Reconnaissance #92 - 20 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 news@raps.org.


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