Regulatory Focus™ > News Articles > Regulatory Reconnaissance (21 October 2013)

Regulatory Reconnaissance (21 October 2013)

Posted 21 October 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • FDA to extend biosimilar deadlines due to shutdown (BioCentury) (IHP-$)
  • Former VP Dick Cheney had heart device partially disabled to prevent a terrorist from sending a fatal shock (Washington Post) (Forbes) (MedCity News) (Bloomberg)
  • FDA Largely Denies Citizen Petition on Single, Shared REMS System, But Outlines Agency Standards and Processes (FDA Law Blog)
  • Rx Companies Push For Exemptions To Breadth Of FDA Inspections (Pink Sheet-$)
  • FDA Issues 483 to Indian Manufacturer Smruthi Organics for Violations in Unit (India Times)
  • Hospira issues policy paper on biosimilar naming (DSN) (Hospira) (Pink Sheet-$)
  • FDA ban's side effects: job losses (Live Mint)

In Focus: International

  • Just Posted: Revisions to the World Medical Association Declaration of Helsinki (JAMA) (MedPage Today)
  • EU trade deal give pharma two years' patent gain in Canada (Pharma Times)
  • EU medical devices revision: counting down to the plenary vote (MedDevices Legal)
  • CHMP backs new dose-finding approach (BioCentury) (EMA)
  • Japan seeks answers in HPV vaccine probe (SCRIP-$)

US: Pharmaceuticals/Biotechnology

  • FDA to extend biosimilar deadlines due to shutdown (BioCentury) (IHP-$)
  • FDA Largely Denies Citizen Petition on Single, Shared REMS System, But Outlines Agency Standards and Processes (FDA Law Blog)
  • Rx Companies Push For Exemptions To Breadth Of FDA Inspections (Pink Sheet-$)
  • Actelion gets US green light for new PAH drug Opsumit (FDA) (PMLive) (Pharma Letter-$) (Reuters) (Forbes) (SCRIP-$) (MedPage Today) (Fierce) (Fierce) (BioCentury) (Pharma Times) (Bloomberg)
  • GSK and Genmab file Arzerra for first-line use in US (PMLive) (SCRIP-$) (GSK) (BioCentury) (Pharma Times)
  • FDA Issues 483 to Indian Manufacturer Smruthi Organics for Violations in Unit (India Times)
  • Hospira issues policy paper on biosimilar naming (DSN) (Hospira) (Pink Sheet-$)
  • FDA ban's side effects: job losses (Live Mint)
  • FDA Rebuffs Alimera Diabetes Eye Treatment Over Concerns (Law 360-$)
  • FDA panel backs Impavido for leishmaniasis (BioCentury) (Pink Sheet-$)
  • FDA OK's Cimzia in ankylosing spondylitis, but rejects axSpA (SCRIP-$) (BioCentury)
  • Cubist Announces FDA Approval for Expanded Use of Entereg (Press)
  • Iroko Pharmaceuticals Receives FDA Approval for Zorvolex (Press) (BioCentury) (MedCity News)
  • Catalyst Pharma: Orphan Drug Poseur, Profiteer (The Street)
  • Drug compounder blamed in deaths of 2 Nevada children (Tennessean)
  • FDA's Hamburg on Research Investment and Clearing the Hurdles to Drug Approvals (Medscape)
  • Technical Difficulties Prevented Priority Review Of GSK Melanoma Drugs (Pink Sheet-$)
  • Watson's Bupropion XL Undone By Outlier Patient, Bankrupt CRO (Pink Sheet-$)
  • Cholesterol Drug Approvals May Hinge On Outcomes Studies; FDA Rejects Diabetes-style Tiered Trials (Pink Sheet-$)
  • REMS Modification Studies Could Use Foreign Markets As Controls (Pink Sheet-$)
  • Jubilant smoking cessation aid gets FDA nod (BioSpectrum)
  • Company Recalls Generic Albuterol (MedPage Today)
  • Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.25% Marcaine Due to Presence of Particulate Matter (FDA)
  • Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products (FDA)

US: Pharmaceuticals and Biotechnology: General

  • Exploiting your supply chain: confessions of a counterfeiter (Securing Industry)
  • Eli Lilly: "Serialization Needs Standardization" (RxTrace)

US: Medical Devices

  • Former VP Dick Cheney had heart device partially disabled to prevent a terrorist from sending a fatal shock (Washington Post) (Forbes) (MedCity News) (Bloomberg)
  • Device Approval Using Registry Data Shows FDA's Confidence, Interest (IHP-$)
  • Addressing The Backlog: Government Shutdown Ends, Now FDA Has To Catch Up (Gray Sheet-$)
  • Recalled ICD Leads Can Be Extracted Safely, Cleveland Clinic Study Shows (Gray Sheet-$)
  • Bard LifeStent Solo Vascular Stent: Class 1 Recall - Failure to Deploy (FDA)

US: Dietary Supplements

  • "Similar To Meth" Report On Supplement Ingredient Draws Firm's Rebuke (Tan Sheet-$)

US: Assorted And Government

  • NIH back to work but faces research backlog (CBS)
  • Lobbyists Ready for a New Fight on U.S. Spending (NYTimes)
  • Enforcement Report - Week of October 2, 2013 (FDA)

Upcoming Meetings And Events

  • 17-18 October 2013: Anti-Infective Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 22-23 October 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA) (POSTPONED)
  • 24-25 October 2013: Antiviral Drugs Advisory Commitee Meeting (FDA) (Day 2)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU medical devices revision: counting down to the plenary vote (MedDevices Legal)
  • CHMP backs new dose-finding approach (BioCentury) (EMA)
  • Draft reflection paper on the risk of antimicrobial resistance transfer from companion animals (EMA) (EMA)
  • Eisai Executives Warns U.K.'s NICE To Change Approval System (PharmAsia-$) (The Times-$)
  • Workshop on the clinical investigation of new medicines for the treatment of multiple sclerosis (EMA)

Asia

  • India Relaxes Rules for Barcoding on Exported Medicines (PharmaBiz)
  • Indian Health ministry allows import of prohibited drugs in small quantities exclusively for personal use (Pharmabiz)
  • Japan seeks answers in HPV vaccine probe (SCRIP-$)
  • CFDA Issues Warning Against Allopurinol Gout Drug Over Side Effects (PharmAsia-$)
  • RFID pilot checks Chinese meds for authenticity (Securing Industry)

Other International

  • Just Posted: Revisions to the World Medical Association Declaration of Helsinki (JAMA) (MedPage Today)
  • IMDRF Announces November Meeting in Brussels, Will Provide Progress Reports on Ongoing Programs (IMDRF) (Agenda)
  • EU trade deal give pharma two years' patent gain in Canada (Pharma Times)

General Regulatory And Interesting Articles

  • If Everyone Hates the FDA Approval Process, Let's Fix It (HBR)
  • Why Scientists Are Trying Viruses To Beat Back Bacteria (NPR)
  • Inhaled Stem Cells Might Replace Lost Neurons (Scientific American)

Regulatory Reconnaissance #183 - 21 October 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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