Regulatory Focus™ > News Articles > Regulatory Reconnaissance (23 July 2013)

Regulatory Reconnaissance (23 July 2013)

Posted 23 July 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Unified Agenda for FDA Officially Released (DHHS)
  • FDA Labeling Change Rule Is Most Prominent Item On Agency's To-Do List (Pink Sheet)
  • Biogen: Patient Death 'Unlikely' Linked to MS Drug Tecfidera (SCRIP) (Fierce) (BioCentury) (WSJ) (Reuters) (Forbes)
  • Medtronic's Auto-Adjust Insulin Pump on Cusp of FDA Approval (Fierce)
  • Final Rule: Exclusion of Orphan Drugs for Certain Covered Entities under 340B Program  (OFR) (Pink Sheet) (PharmExec) (BioCentury) (Law 360) (IHP)
  • Medical Groups Resist Possible Standards Loosening (The Hill)
  • Study: A Critical Review of Methods to Evaluate the Impact of FDA Regulatory Actions (Wiley)

In Focus: International

  • Secret GSK Report Showed 'Mortal Sins' in Drug Development Process, Including Buried Animal Results (NYTimes)
  • China FDA Launches Major Enforcement Campaign; Official Cautions Rainy Days Ahead (PharmAsia)
  • EU Patient Groups Commit To Transparency after Leaked Memo (Pharma Times)
  • EU Gives Orphan Drug Status to Procysbi (DD&D) (Pharma Letter)
  • EU Membership for Croatia to Change Medical Device Registration Rules...Eventually (Mass Device)
  • Scottish PIP Breast Implant Patients Demand Wider Government Help (Fierce)
  • India Health Minister Cites Rare Way to Cancel Roche's Herceptin Patent (PharmAsia)

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

US

Pharmaceuticals/Biotechnology
  • Biogen: Patient death 'unlikely' linked to MS drug Tecfidera (SCRIP) (Fierce) (BioCentury) (WSJ) (Reuters) (Forbes)
  • Lupin gets USFDA nod for diabetes drug (India Times)
  • FDA Approves ANDA for BD RX's Generic Zofran (Ondansetron HCl, #202253) (FDA)
  • Forest Laboratories, Inc. Announces Settlement Agreement with Amerigen Pharma in Bystolic Patent Litigation (Forest)
  • Isis Pharma drug reduces blood fat by 64 pct in mid-stage study (Reuters) (BioCentury) (SCRIP)
  • Kinex Announces that the US FDA Allows their IND for Oraxol to Begin Clinical Trials in the US (Kinex) (BioSpectrum)
  • FDA Performs Re-inspection of AMRI's Burlington MA Facility (AMRI)
  • 3rd Circ. Orders GSK To Trial Over Paxil Deal With Mylan (Law 360)
  • Report: FDA Developing Guidance on Use of Health Care Economic Information (Drug Wonks)
  • FDA Labeling Change Rule Is Most Prominent Item On Agency's To-Do List (Pink Sheet)
Pharmaceuticals: General
  • Final Rule: Exclusion of Orphan Drugs for Certain Covered Entities under 340B Program  (OFR) (Pink Sheet) (PharmExec) (BioCentury) (Law 360) (IHP)
  • FDA Meeting on oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility (FDA)
Medical Devices
  • Medtronic's auto-adjust insulin pump on cusp of FDA approval (Fierce)
  • Medical groups resist possible standards loosening (The Hill)
  • Reflectance Medical's Non-Invasive Muscle Oxygen Saturation and pH Monitor FDA Cleared (MedGadget)
  • FDA clears Reflectance's muscle oxygen saturation, tissue acidosis sensor (Mobihealth News)
  • World's Only Ceiling Mounted Intraoperative CT from IMRIS Gets FDA OK (MedGadget)
  • Class 1 Recall for LeMaitre Albograft Products due to Blood Leaking from Surface After Graft Implantation (FDA)
Assorted And Government
  • Unified Agenda for FDA Officially Released (DHHS)
  • A critical review of methods to evaluate the impact of FDA regulatory actions (Wiley)
  • NIH commits $24 million annually for Big Data Centers of Excellence (NIH)
  • GOP support grows to force government shutdown over funding ObamaCare (The Hill)
  • Industry pushing for further clarity on Sunshine Act (MM&M)
  • SEC Poised to Modify 'No Admit, No Deny' Policy in Settlements (Health Leaders Media)
  • Self-Reporting Leads to SEC Entering its First Non-Prosecution Agreement Regarding FCPA Violations (McGuire Woods)
  • False Claims Act settlements often are business deals (Federal Times)
  • US Debates Dropping Duty for Drug Intermediates Imports (In-Pharma Technologist)
  • Bipartisan Bill Aimed at 'Patent Trolls' Introduced in U.S. House (eWeek)
  • ITC Investigations Faster than Before (FDA Lawyers Blog)
Upcoming Meetings And Events
  • 22-23 July 2013: Arthritis Advisory Committee Meeting (FDA)
  • 23 July 2013: Meeting: Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study (FDA)
  • 23 July 2013: Hearing: "Pay-for-Delay Deals: Limiting Competition and Costing Consumers" (Senate Judiciary Cmmte)
  • 23 July 2013: Brookings Webinar: Active Medical Product Surveillance Roundtable (FDA)
  • 24 July 2013: House Hearing on US-EU Free Trade Agreements and Regulatory Barriers (House)
  • 25 July 2013: CBER Webinar on its Direct Recall Classification Program (FDA)
  • 25 July 2013: Webinar on FDA's Draft GFI on Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment (FDA)
  • 25 July 2013: Webinar on FDA's Draft GFI On Rheumatoid Arthritis - Developing Drug Products For Treatment (FDA)
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Scottish PIP breast implant patients demand wider government help (Fierce)
  • EU Patient groups commit to transparency after leaked memo (Pharma Times)
  • EU Gives Orphan Drug Status to Procysbi (DD&D) (Pharma Letter)
  • E.U. membership for Croatia to change medical device registration rules...eventually (Mass Device)
  • NICE 'no' for MabThera (Pharmafile) (Pharma Letter) (PMLive)
  • Novaliq GmbH Announces European Market Approval for NovaTears OTC (Novaliq)
  • UK Looks to Make Tramadol a Class C Drugs (DOH)
  • Sandoz biosimilar named market leader in Europe (DSN)
  • GW Pharmaceuticals Files New Regulatory Application to Expand Sativex Approval to France (PharmPro)
  • European Medicines Agency Approves SmPC Change to Baxter's ADVATE to Include Information on PK-Guided Dosing Study (Baxter)

Asia

  • Secret GSK Report Showed 'Mortal Sins' in Drug Development Process, Including Buried Animal Results (NYTimes)
  • China FDA Launches Major Enforcement Campaign; Official Cautions Rainy Days Ahead (PharmAsia)
  • China Travel Agency in Glaxo Probe Used by Sanofi, Roche (Bloomberg)
  • India Health Minister Cites Rare Way To Cancel Roche's Herceptin Patent (PharmAsia)
  • Announcement: Dates of the 18th AHWP Annual Meeting & the 1st AHWP-RAPS Joint Conference changed to 2-5 Dec 2013 (AHWP)
  • Head of Chinese Pharmaceutical Company Arrested for Trafficking Cannabis (BioSpectrum)
  • Korea to spend $8.9 bn to develop 20 drugs by 2017 (BioSpectrum)
  • China probes: AstraZeneca claims rep visit is isolated case (SCRIP)
  • Chugai To Focus On iPS Cells For Quick Drug-Safety Tests At R&D Stage (PharmAsia)

Other International

  • New laws for medical device registration imminent in Argentina (Mass Device)
  • Novo Nordisk Recalls NordiPen in Australia Due to Potential for Under-Dosing (TGA)

General Regulatory And Interesting Articles

  • Medtech Scandals: Six Controversies that Changed the Industry (Medtech Insider)
  • Decongestants in pregnancy linked to birth defects (Reuters)
  • Social media, web queries not ready as disease surveillance tools (Fierce)
  • QbD: The Devil Is in the Data (PharmaManufacturing)

Regulatory Reconnaissance #114  - 23 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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