Regulatory Focus™ > News Articles > Regulatory Reconnaissance (17 June 2013)

Regulatory Reconnaissance (17 June 2013)

Posted 17 June 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • US lawmakers slam FDA over unused industry user fees (Pharma Times)
  • Woodcock says FDA 'actively investigating' antidiabetics (BioCentury) (BioCenturyTV)
  • FDA Stands Firm On ANDA Stability Guidance's 2014 Enforcement Deadline (Pink Sheet)
  • FDA Releases Final Study Results of a Mini-Sentinel Postlicensure Observational Study of Rotavirus Vaccines and Intussusception (FDA) (MiniSentinel)
  • Robotic surgery is high-tech 'tour de force' -- but is it safe? (NBC) (NBC)
  • Firmer Breast Implant Gets FDA Nod (FDA) (Mentor) (MedPage Today) (MNT) (Mass Device)
  • FDA Sees "Extraordinary" Interest in Human Factors Guidance (MDDI)

In Focus: International

  • EU notified bodies toughen up their act (Clinica)
  • EMA holding workshop on parallel scientific advice (BioCentury) (EMA)
  • EU: Doctors should consider heart attack risks when prescribing painkiller (Reuters)
  • Japan Suspends Urging HPV Shots For Girls Due To Adverse Affects (PharmAsia) (SCRIP)
  • Health Canada to Use US FDA's Electronic Submission Gateway (ESG) for eCTD Submissions (Aptiv Solutions)
  • Canadians have access to fewer new medicines than in most OECD countries (Pharma Letter)

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

US

Pharmaceuticals/Biotechnology
  • Woodcock says FDA 'actively investigating' antidiabetics (BioCentury) (BioCenturyTV)
  • How Do You Define An Orphan Drug? Not By The Price, FDA Says (RPM Report)
  • FDA Stands Firm On ANDA Stability Guidance's 2014 Enforcement Deadline (Pink Sheet)
  • Orphan Designation Removals To Be Revealed By FDA (Pink Sheet)
  • FDA Releases Final Study Results of a Mini-Sentinel Postlicensure Observational Study of Rotavirus Vaccines and Intussusception (FDA) (MiniSentinel)
  • Avoiding Tort Hell? Pfizer Gets A Chance To Overturn Generic Injury Ruling (Pharmalot)
  • Questcor Pays $135 Million to Acquire Rights to a Competitor's Drug (NYTimes)
  • FDA's latest efforts in patient-focused drug development now in full swing (FDA) (FDA)
  • New long-term data reinforce safety profile of Pradaxa® for stroke prevention in AF (BI)
  • 8th Circ. Shields Branded Cos. For Generic-Drug Harm (Law 360)
  • Generic Drug Labeling Claims Not Preempted by Mensing (Law 360)
  • Access To The Morning After Pill Remains An Issue: Baruch Explains (Pharmalot)
  • New Opportunity For CER As Placebo Trials Show Shrinking Drug Efficacy Margins - Health Affairs (Pink Sheet)
  • FDA Approves ANDAs for Carlsbad's Clonidine Hydrochloride (#202297), Alkem Labs' Mycophenolate Mofetil (#200197) (FDA)
  • TherapeuticsMD Investigational New Drug Filing Accepted By FDA (Business Wire)
  • Incyte Drug Jakafi® (ruxolitinib) Improved Overall Survival in Phase III Trial of Patients with Myelofibrosis (Business Wire)
  • FDA Updates Jakafi Label with Expanded Dosing Guidance and New Safety Information (Drug Safety Monitor)
  • Form FDA-483 Sent to Compounding Pharmacy Home Infusions Solutions, Inc. (FDA)
  • Avandia Panel Wants Another Trial: Pipe Dream Or Post-market Benchmark? (Pink Sheet)
  • Avandia Review Endorsement Aided By Good Data, Cultural Shift On Safety (Pink Sheet)
  • Harvard Pilgrim drops compound drug coverage (Pharmalot)  (Fierce)
  • CDC: Cut Back on Doxycycline Use (MedPage Today)
  • Minnesota Attorney General Confirms They Did Not Exonerate UMN in Markingson Death (Scientific American)
  • Manhattan Institute Fellow: Steven Nissen Had Significant Conflicts on Avandia (MarketWatch)
  • Positive survival data for B-MS/AbbVie's blood cancer drug (Pharma Times)
  • Gilead Announces Interim Phase 2 Data for Idelalisib Showing Response in Refractory Indolent Non-Hodgkin's Lymphoma (Gilead)
Medical Devices
  • Robotic surgery is high-tech 'tour de force' -- but is it safe? (NBC) (NBC)
  • Firmer Breast Implant Gets FDA Nod (FDA) (Mentor) (MedPage Today) (MNT) (Mass Device)
  • FDA Sees "Extraordinary" Interest in Human Factors Guidance (MDDI)
  • Exact Sciences Completes Modular PMA For Cologuard (Gray Sheet)
  • Rep. Honda Reintroduces Mobile Health Innovation Legislation (iHealth Beat)
  • FDA Submits Foreign IND Regulation to OMB for Review (OMB)
  • Industry, Patient Advocates Spar Over Need for 510(k)s for Modifications (FDA News)
  • FDA Panel Recommends Stricter Regulatory Standards For All Rapid Influenza Tests (Gray Sheet)
  • FDA approves St. Jude's safety-enhanced devices (Cardiovascular Business)
  • Glooko Launches New Version Of Diabetes Management App (Gray Sheet)
  • Study: MoM Hip Replacements May Cause Long-Term Systemic Changes (FDA News)
  • MDMA Statement on FDA's 510(k) Device Modifications Meeting (MDMA)
Assorted and Government
  • US lawmakers slam FDA over unused industry user fees (Pharma Times)
  • Public Citizen's Wolfe Still Needling FDA (MedPage Today)
  • Behind Scolding of the F.D.A., a Complex and Gentle Judge (NYTimes)
  • Just a Few More Things for FDA to Focus on (Strengthen FDA)
  • Opinion: The FDA is regulating the wrong things (KevinMD)
  • CMPI Launches Valueofinnovation.org (DrugWonks)
  • House passes bill to strengthen CIO authority, reform IT (Federal Times)
  • John LaMattina: Pharma's R&D deals with foundations may hit reputations (Pharmafile)
  • SCRIP's Capitol Capsule (SCRIP)
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 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 notified bodies toughen up their act (Clinica)
  • EMA holding workshop on parallel scientific advice (BioCentury) (EMA)
  • PRAC recommends the same cardiovascular precautions for diclofenac as for selective COX-2 inhibitors (EMA)
  • EU: Doctors should consider heart attack risks when prescribing painkiller (Reuters)
  • Celgene gets fresh Revlimid OK, pomalidomide impresses again (Pharma Times)
  • PRAC recommends restricting the use of flupirtine-containing medicines (EMA)
  • J&J subsidiary Codman Neuro lands CE Mark for clot removal device (Mass Device)
  • Pricing and reimbursement conditions for InterMune's Esbriet in Italy (Pharma Letter)
  • Committee for Medicinal Products for Veterinary Use (CVMP) Meeting of 11-13 June 2013 (EMA)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10-13 June 2013 (EMA)
  • Frustrated by regulators, Professor turns to internet to distribute polypill (Financial Times)
  • Iceland's EU bid is over, commission told (EU Observer)

Asia

  • Project revital: India's drug regulator is getting a makeover but better enforcement and safer medicines are yet a chimera (Business Today)
  • India's Ranbaxy has "ambitious growth plan" in U.S., will file generic drugs for marketing exclusivity (Reuters)
  • Japan Suspends Urging HPV Shots For Girls Due To Adverse Affects (PharmAsia) (SCRIP)
  • Health ministry to impose stringent measure to keep tab on quality of API imports into India (PharmaBiz)
  • Roche's Avastin approved in Japan for treatment of brain cancer (Reuters) (Roche) (PMLive)
  • India and NICE to collaborate on 'evidence-informed' healthcare (SCRIP)
  • Thailand Trials Showing HIV/AIDS Drug Success Awakens CL Debate (PharmAsia)
  • Indian pharma concerned over hazardous effluents; seeks simpler process & funding to adopt green chemistry (PharmaBiz)
  • Wockhardt gets kicked in the gut again (Fierce)

Other International

  • Health Canada to Use US FDA's Electronic Submission Gateway (ESG) for eCTD Submissions (Aptiv Solutions)
  • Canadians have access to fewer new medicines than in most OECD countries (Pharma Letter)
  • New Zealand Takes Steps to Allow Recreational Use Of 'Low Risk' Designer Drugs (Medical Daily)

General Regulatory and Interesting Articles

  • Study Shows Pill Prevents H.I.V. Among Drug Addicts (NYTimes)
  • Osteoporosis drug stops growth of breast cancer cells, even in resistant tumors (EurekAlert)

Regulatory Reconnaissance #89 - 17 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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