Regulatory Focus™ > News Articles > Regulatory Reconnaissance (16 July 2013)

Regulatory Reconnaissance (16 July 2013)

Posted 16 July 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Generic Drug Makers Will Soon Face the Regulatory Music (Forbes)
  • CDER Adds Antibiotics Specialist Robert Guidos for New Senior Advisor Role (Pink Sheet) (BioCentury)
  • FDA Could Release GMP Data to Prod Manufacturing Improvements (Pink Sheet)
  • FDA Grants QIDP Designation to Eravacycline, Tetraphase's Lead Antibiotic Product Candidate (Tetraphase) (AP) (BioFlash) (SCRIP)
  • First ADHD Brain Wave Test Approved by FDA (FDA) (CBS) (NBC) (NYTimes) (The Hill) (PMLive) (Pharma Times)
  • Leahy Wants NIH to Make Myriad 'License Out' Patents (Law 360)
  • Implementing a National Cancer Clinical Trials System for the 21st Century (IOM)

In Focus: International

  • Four Drugmakers Face China Probes as GSK Woes Widen (Bloomberg)
  • India Ex-Im Bank to Help Domestic Drug Makers be US-FDA Compliant (Live Mint)
  • Implementation of ICH Q11 Guidelines a Challenge for Indian Pharmaceutical Companies (PharmaBiz)
  • Alexion's Soliris Receives Positive Opinion from the COMP (Alexion)
  • NICE 'No' for Pfizer's Bosulif (Pharma Times) (PMLive) (Pharmafile) (SCRIP) (BioCentury)
  • Guide to the Preparation, Use and Quality Assurance of Blood Components (EDQM)
  • The Eighth Edition of the European Pharmacopoeia Available (EDQM)
  • Big Pharma Begins Mutually Recognizing GCP Training, Site Qualifications Outsourcing Pharma)
  • Australia Releases Guidance for Dossier Submissions (TGA)

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

US

Pharmaceuticals/Biotechnology
  • Generic Drug Makers Will Soon Face the Regulatory Music (Forbes)
  • CDER Adds Antibiotics Specialist Robert Guidos For New Senior Advisor Role (Pink Sheet) (BioCentury)
  • FDA Could Release GMP Data To Prod Manufacturing Improvements (Pink Sheet)
  • First Half of 2013: Ten FDA Enforcement Letters (Porzio)
  • A Punt Return, Not a Fumble Return, in the Second FDA Resolution of a 180-Day Exclusivity Punt Case (FDA Law Blog)
  • Analyses of Defect Reports by Ireland's IMB and FDA Highlight Packaging and Labeling as Key Pharma Manufacturing Problem Area (IPQ)
  • FDA Grants QIDP Designation to Eravacycline, Tetraphase's Lead Antibiotic Product Candidate (Tetraphase) (AP) (BioFlash) (SCRIP)
  • FDA Approves ANDAs for Allied Pharmaceuticals' Gabapentin (#203244), Roxane's Oxycodone HCl (#203208), Alkem Labs' Mycophenolate Mofetil (#200197), Novast Labs' Desogestrel; Ethinyl Estradiol (#091234) and Bicon Pharma's Folic Acid (#091145) (FDA)
  • Iroko Pharmaceuticals Announces Acceptance for NDA Filing of Lower Dose Submicron Indomethacin for the Treatment of Mild to Moderate Acute Pain in Adults (Iroko)
  • Actavis' Generic Version of Lamictal ODT Receives FDA Approval (Actavis)
  • Caution Urged on Gonorrhea Drugs (NYTimes)
  • New Study Shows Men Taking Cialis (tadalafil) Tablets Once Daily Returned to Normal Erectile Function after Incomplete Response to As-Needed PDE5 Inhibitor Therapy (Eli Lilly)
  • FDA declares 'victory,' but no jail time for US Avastin fraudster (SCRIP)
  • Counterfeit Drugs: Prosecuting the Profiteers, Protecting the Public Health (FDA)
  • Comment of GPhA to FDA on Draft Guidance on SUPAC (Docket)
Pharmaceuticals: General
  • Track And Trace May Improve Patient Adherence: Monroe Explains (Pharmalot)
  • The Best Selling Drugs Since 1996 - Why AbbVie's Humira Is Set To Eclipse Pfizer's Lipitor (Forbes)
  • Board Outlines Audio, Braille, Large Print Drug Labeling For Blind Patients (IHP)
  • Why You Should Care About the Drugs Your Doctor Prescribes (ProPublica)
Medical Devices
  • First ADHD brain wave test approved by FDA (FDA) (CBS) (NBC) (NYTimes) (The Hill) (PMLive) (Pharma Times)
  • Leahy Wants NIH To Make Myriad License Out Patents (Law 360)
  • Medicare clinical utility demands killing model for molecular diagnostic LDTs (BioCentury)
  • SynGen Inc. Receives FDA 510K Clearance to Market SynGenX-1000 Cord Blood Processing Platform (SynGen)
  • Luminex Corporation Receives FDA and European Clearance for an Updated Version of Its Comprehensive Genotyping Assay, xTAG CYP2D6 Kit (Luminex)
  • Qualigen Receives FDA Clearance for Its FastPack Vitamin D Immunoassay (Qualigen)
  • Why are universities trying to limit access to breast cancer tests? (Washington Post)
Assorted And Government
  • Implementing a National Cancer Clinical Trials System for the 21st Century - Second Workshop Summary (IOM)
  • Clinical trials for cancer, 1 patient at a time: New Department of Systems Biology reverse engineers tumors to tailor cancer therapy to the individual patient (EurekAlert)
  • 'Do Clinical Trials Work?' -- NY Times Op-ed Misses An Opportunity To Teach And Instead Resorts To Negativism (Forbes)
  • Yes, Clinical Trials Work (Simply Statistics)
  • Obama steps up fight against HIV (The Hill) (Executive Order)
Upcoming Meetings And Events
  • 16 July 2013: Hearing: Reforming the Drug Compounding Regulatory Framework (House)
  • 18 July 2013: Meeting: Dental Products Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 18 July 2013: Meeting: Anesthetic and Analgesic Drug Products Advisory Committee (FDA)
  • 23 July 2013: Brookings Webinar: Active Medical Product Surveillance Roundtable (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Alexion's Soliris (eculizumab) Receives Positive Opinion from the Committee for Orphan Medicinal Products for Treatment of Neuromyelitis Optica (NMO) (Alexion)
  • NICE 'no' for Pfizer's Bosulif (Pharma Times) (PMLive) (Pharmafile) (SCRIP) (BioCentury)
  • Guide to the Preparation, Use and Quality Assurance of Blood Components (EDQM)
  • The 8th Edition of the European Pharmacopoeia available (EDQM)
  • Stentys' new CE Mark indications expand its potential PCI footprint (Mass Device)
  • Danish Doc Charged With Fraud For Payments From Drugmakers (Pharmalot)
  • First IQWiG assessment of the established drug market finds advantage for Januvia (Pharma Letter)

Asia

  • Four Drugmakers Face China Probes as Glaxo Woes Widen (Bloomberg)
  • China Targets Big Pharma (WSJ)
  • GSK probe shows the peril of operating in corrupt markets (FT)
  • Police Say Sexual Favors Spur $1.5 Billion Glaxo China Sales (Bloomberg)
  • GSK response to China investigation (GSK)
  • India Ex-Im Bank To Help Domestic Drug Makers Be U.S.-FDA Compliant (Live Mint)
  • Implementation of ICH Q11 guidelines a challenge for Indian pharma: Dr Desai (PharmaBiz)
  • Five reasons why an Indian pioglitazone flip-flop is bad practice  (SCRIP)
  • Doctor's Letter Triggers Pioglitazone Ban; India's Health Ministry Under Fire (PharmAsia)
  • Novartis keeps distance over Diovan data manipulation claims (Pharma Times)
  • Hundreds of millions of vulnerable Indian citizens lack free access to essential generic medicines while policies risk undermining new medicines research funding (Business Wire)

Other International

  • Big Pharma Begins Mutually Recognizing GCP Training, Site Qualifications Outsourcing Pharma)
  • ANVISA sets performance targets for next 12 months (Mass Device)
  • Australia Releases Guidance for Dossier Submissions (TGA)
  • J&J smacked with Canadian lawsuit claiming vaginal mesh implant damage (Fierce)
  • Enhanced IP protection for medicines will help Canada with trade agreements, says think-tank (Pharma Letter)
  • Medecins Sans Frontieres wants the Trans-Pacific Partnership to amend terms (Pharma Letter)
  • South Africa Joins European Pharmacopoeia as Observer (In-Pharma Technologist)
  • South Africa Weighs Starting HIV Drug Treatment Sooner (NPR)

General Regulatory And Interesting Articles

  • Long term aspirin use tied to lower colon cancer risk (Reuters)
  • Offer all young gay men HPV jab, say experts (OnMedica)

Regulatory Reconnaissance #108  - 16 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 news@raps.org.


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