Regulatory Focus™ > News Articles > Regulatory Reconnaissance (13 November 2013)

Regulatory Reconnaissance (13 November 2013)

Posted 13 November 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

  • J&J Said to Reach $4 Billion Deal to Settle Hip Lawsuits (Bloomberg) (NYTimes)
  • Former FDA Commissioners to White House: Limit Antibiotics In Livestock (Pharmalot)
  • US FDA calls for further data on Biogen Idec's Eloctate (Pharma Letter-$) (Pharma Times)
  • Alexion initiates 2nd Soliris recall (SCRIP-$) (Fierce)
  • NPS Pharmaceuticals Announces FDA Acceptance of sNDA for Gattex for Injection (Press)
  • FDA Staff Among the Most Highly Paid US Civil Servants (Wiki Org Charts)

In Focus: International

  • India DCGI Accuses CMO Of Submitting All-False Data For Seven Drugs (PharmAsia-$) (India Times)
  • Sandoz recalls mispackaged TB drugs in India (SCRIP-$)
  • Boehringer Ingelheim submits applications in Europe to extend the indication for the use of Respimat (Press) (Pharma Letter-$)
  • Avedro wins CE Mark for its KXL II system (Mass Device)

US: Pharmaceuticals/Biotechnology

  • Former FDA Commissioners to White House: Limit Antibiotics In Livestock (Pharmalot)
  • US FDA calls for further data on Biogen Idec's Eloctate (Pharma Letter-$) (Pharma Times)
  • Alexion initiates 2nd Soliris recall (SCRIP-$) (Fierce)
  • NPS Pharmaceuticals Announces FDA Acceptance of sNDA for Gattex for Injection (Press)
  • The Liability Sea Change Under the Proposed CBE-0 Rules for ANDAs (Lachman)
  • FDA's new escape clause (Drug Wonks)
  •  Vanda's Tasimelteon: A Safe, Efficacious Drug In Search Of An Indication (Pink Sheet-$)
  • What The Delay Of A Promising Muscular Dystrophy Drug Means For Patients, Investors And All Of Biotech (Forbes)
  •  Atossa Genetics working toward new FDA clearance, 2014 product launches (MedCity News)
  • Johnson and Johnson Corporate Integrity Agreement: The Progression of Life Science Corporate Integrity Agreements (Policy and Medicine)
  • J&J's $2.2 Billion Settlement Won't Stop Big Pharma's Addiction To Off-Label Sales (Forbes)
  • More positive data for Vifor Pharma's Ferinject (Pharma Times)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • J&J Said to Reach $4 Billion Deal to Settle Hip Lawsuits (Bloomberg) (NYTimes)
  • Cochlear Limited gets OK'd by FDA advisory panel (Mass Device) (FDA)
  • IntelligentMDx Receives FDA Clearance for IMDx C. difficile for Abbott m2000 Assay, Completes Move of Corporate Headquarters to Waltham (Press)
  • NLT Spine Receives FDA Clearance for Second Generation PROW FUSION and eSPIN Spinal Devices (MedGadget)
  • Endoshape Receives FDA Clearance for Medusa Peripheral Vascular Plug (MedGadget)

US: Assorted And Government

  • FDA Staff Among the Most Highly Paid US Civil Servants (Wiki Org Charts)
  • Lawmakers seek GAO study of federal regenerative medicine efforts (SCRIP-$)

Upcoming Meetings And Events

  • 13 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Boehringer Ingelheim submits applications in Europe to extend the indication for the use of Respimat (Press) (Pharma Letter-$)
  • Avedro wins CE Mark for its KXL II system (Mass Device)
  • EMA Workshop Presentations: Best use of medicines legislation to bring new antibiotics to patients and combat the resistance problem (EMA)
  • EMA Workshop Presentations: Biosimilars Workshop (EMA)

Asia

  • India DCGI Accuses CMO Of Submitting All-False Data For Seven Drugs (PharmAsia-$) (India Times)
  • Sandoz recalls mispackaged TB drugs in India (SCRIP-$)
  • Health ministry to ban all hazardous and doubtful therapeutic efficacy drugs in market (PharmaBiz)
  • Manufacturers of FDCs for veterinary use not required to file safety data: DCGI (PharmaBiz)

Other International

  • Industry frustration swells in South Africa as regulation progress drags (Clinica-$)

General Regulatory And Interesting Articles

  • William Pollack Dies at 87; His Vaccine Saved Infants (NYTimes)

Regulatory Reconnaissance #201 - 13 November 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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