Regulatory Focus™ > News Articles > Regulatory Reconnaissance (12 July 2013)

Regulatory Reconnaissance (12 July 2013)

Posted 12 July 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • Aveo Subpoenaed by US Regulator Over Kidney Cancer Drug (Bloomberg) (SCRIP) (Fierce) (Xconomy) (Aveo 8K Filing)
  • Lies, Damned Lies, and Statistics: Another Report on Drug Patent Settlement Agreements (FDA Law Blog) (Report) (GPhA Statement)
  • FDA Approves NDA for Osmotiva Pharmaceutical's Khedezla (desvenlafaxine, #204683) (FDA)
  • BioCryst's Failed Flu Drug Gets Another Shot at FDA Success (Fierce) (BioCryst)
  • CMS Denies Amyvid Coverage: A Bigger Message to Biopharma (RPM Report First Take)
  • US Sentences British Citizen for Distributing Fake Avastin (WSJ)
  • UDI Final Rule Listed For July Release in HHS Regulatory Agenda (Gray Sheet)
  • You've Been Warned: This Week in FDA Med Tech Warning Letters (Fierce)
  • FDA to Assist Brain Tumor Drug Development, Consider Alternate Endpoints (BrainTumor.org)

In Focus: International

  • After 'Regulatory Deficiencies' Are Found, France Withdraws Ceraver Devices From Market (ANSM)
  • European Pharmacopoeia Will Detail All Plants in API Production Process, says EDQM (In-Pharma Technologist)
  • Highlights From the Most Recent PRAC Meeting (EMA)
  • IMI Call for Social Media Detection of Adverse Events (Eye for Pharma)
  • GSK Withdraws Ellipta Submission in Japan due to Lack of Enrollment in 52-Week Study (GSK)
  • EU Provides Updates on Risk Management Plan for Swift Approvals, Product Registration from Markets Like India (PharmaBiz)
  • Cipla Arthritis Drug Found By India Inspectors to be Substandard (PharmAsia)
  • CDSCO Sets Up Panel to Revise Guidance for Post Approval Changes of Biological Products (PharmaBiz)

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

US

Pharmaceuticals/Biotechnology
  • Aveo Subpoenaed by U.S. Regulator Over Kidney Cancer Drug (Bloomberg) (SCRIP) (Fierce) (Xconomy) (Aveo 8K Filing)
  • Lies, Damned Lies, and Statistics: Another Report on Drug Patent Settlement Agreements (FDA Law Blog) (Report) (GPhA Statement)
  • FDA Approves NDA for Osmotiva Pharmaceutical's Khedezla (desvenlafaxine, #204683) (FDA)
  • BioCryst's failed flu drug gets another shot at FDA success (Fierce) (BioCryst)
  • CMS Denies Amyvid Coverage: A Bigger Message To Biopharma (RPM Report First Take)
  • Sanofi's ImmuCyst available in next year, Alliance Pharma says (Fierce)
  • As Scrutiny of Compounders Increase, NCPA Adds Influential Lobbyist to Defend Against Changes (The Hill)
  • FDA Still Under Gun On Antibiotics, Despite Hopeful Signs (Law 360)
  • The Generic Preemption Door Stays Open, At Least Until The Facts Matter (Drug and Device Law)
  • U.S. Sentences British Citizen for Distributing Fake Avastin (WSJ)
  • Number Of Annual New Drug Approvals To Treat Neglected Diseases Has Nearly Doubled Between The Early-2000s And 2009-12, According To The Tufts Center (MNT)
  • Notification of Voluntary Market Recall of MENVEO lot # M12118 (FDA)
  • ALK's dust mite pill hits Ph III targets (Pharma Times)
  • Phase III success with anthrax vaccine in post-exposure prophylaxis (SCRIP)
  • Agency Information Collection Activities; Proposals, Submissions, and Approvals: Human Cells, Tissues, and Cellular and Tissue-Based Products, Establishment Registration and Listing, etc (FDA)
Pharmaceuticals: General
  • Study: "Good enough" only goes so far for private-label OTC medications (Business Wire)
  • Pfizer's Prevnar drives big fall in hospital visits (Fierce)
  • Ready Access to Plan B Pills in NYC Schools (NYTimes)
Medical Devices
  • UDI Final Rule Listed For July Release In HHS Regulatory Agenda (Gray Sheet)
  • You've been warned: This week in FDA med tech warning letters (Fierce)
  • AdComm to Discuss the risks and benefits of computed tomography colonography for screening of asymptomatic patients for colorectal cancer (FDA)
  • FDA Gets OMB Approval for Updated Cost Estimate of Obtaining Foreign Letters of Approval to Export a Medical Device (OMB)
  • FDA Clears Novel Device Providing Digital Makeover to Stethoscopes (MDDI)
Assorted And Government
  • FDA to Assist Brain Tumor Drug Development, Consider Alternate Endpoints (BrainTumor.org)
  • FDA Issues Report to Congress on Regulatory Impact on Small Business (FDA) (FDA Voice)
  • SEC votes to lift 80-year-old solicitation ban (SCRIP)
  • FDA Bans BPA in Infant Formula Packaging, But Not For Safety Reasons (MedPage Today)
  • Congressional Investigations: Unique And Significant Risks (JD Supra)
  • FTC Mails Refund Checks to Consumers Who Bought Skechers' Shape-Ups and Other "Toning" Shoes (FTC)
  • Regulatory Lawbreakers: Agencies Fail To Comply With Paperwork Reduction Act (AAF)
  • FDA proposes "action level" for arsenic in apple juice (FDA)
Upcoming Meetings And Events
  • 10 July 2013: Meeting of the Drug Safety and Risk Management Advisory Committee Meeting Announcement (FDA)
  • 12 July 2013: Public Meeting: Implementation of Drug Supply Chain Provisions of Title VII of FDASIA (FDA)
  • 16 July 2013: Hearing: Reforming the Drug Compounding Regulatory Framework (House)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • After 'Regulatory Deficiencies' Are Found, France Withdraws Ceraver Devices From Market (ANSM)
  • European Pharmacopoeia Will Detail All Plants in API Production Process, says EDQM (In-Pharma Technologist)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2013 (EMA)
  • IMI Call for Social Media Detection of Adverse Events (Eye for Pharma)
  • EMA organises training sessions on eSubmission Gateway and web client for PSUR single-assessment submissions (EMA)
  • Will Biogen Idec withdraw its European marketing application for Tecfidera? - One analyst thinks they might (First World Pharma)
  • Center of expertise at heart of NHS England's imminent procurement plan (Clinica)
  • Swissmedic Approves Zonegran (Zonisamide) Monotherapy Treatment For Epilepsy (MNT)
  • EC to launch IMI 2 with EUR 3.5B (BioCentury)
  • New EU rules to combat misleading information on cosmetics (EurActiv)

Asia

  • Incentives tempt China's low-paid doctors (FT)
  • GSK Withdraws Ellipta Submission in Japan Due to Lack of Enrollment in 52-Week Study (GSK)
  • EU provides updates on Risk Management Plan for swift approvals, product registration from markets like India (PharmaBiz)
  • Cipla Arthritis Drug Found By India Inspectors To Be Substandard (PharmAsia)
  • CDSCO sets up panel to revise Guidance for post approval changes of biological products (PharmaBiz)
  • New India Clinical Trial Rules Causing Delay In Application Processing (PharmAsia)
  • GSK: no evidence of China bribes, staff under house arrest (Pharma Times)

Other International

  • Is Canada's 'poor' pharma IP protection jeopardising trade deals? (Pharma Times)
  • Researchers hopeful Viagra could improve survival and health of unborn babies (ABC)

General Regulatory And Interesting Articles

  • Attenuating Attrition in Clinical Trials (BioCentury)
  • Getting medicines to the poor: solving the logistics challenge (The Guardian)

Regulatory Reconnaissance #106  - 12 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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