Regulatory Focus™ > News Articles > Regulatory Reconnaissance (9 September 2013)

Regulatory Reconnaissance (9 September 2013)

Posted 09 September 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

In Focus: US

In Focus: International

  • Germany's FDA: More deaths and side effects related to Bayer's Xarelto in 2013 (Reuters)
  • EMA workshop participants seek more flexible COI rules (BioCentury)
  • Expained: Proposed Legislation to Reform India's Drug Regulatory System (India Times)

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

US

Pharmaceuticals/Biotechnology
  • FDA approves Abraxane for late-stage pancreatic cancer (FDA) (Reuters) (Celgene) (Fierce) (NYTimes) (Pink Sheet) (BioCentury) (SCRIP) (Repeat from Weekend Edition)
  • Generic 180-Day Exclusivities Might Be Imperiled By ANDA Stability Guidance (Pink Sheet) (Lachman Consultants)
  • 3 Must-Watch Issues For Drug Cos. In 2013's Final Stretch (Law 360)
  • BI boosted by strong Spiriva Respimat data (Pharma Times) (BI) (BI)
  • FDA Grants Tentative Approval to Mylan's Generic Rasagiline Mesylate (Brand: Azilect) (FDA)
  • Breakthrough Products Should Be Free Of PDUFA Constraints, Sponsors Say (Pink Sheet)
  • Will CV Verdicts For Onglyza, Nesina Cause FDA To Change Its Tune On Antidiabetic Safety? (Pink Sheet)
  • BioLineRx's BL-8040 Receives Orphan Drug Designation for Treatment of AML (BioLineRx)
  • FDA Primer on Drug Development for Patient Organizations (Policy and Medicine)
Pharmaceuticals and Biotechnology: General
  • For Pharma, Unfamiliar Payers, Tight Cost Structures Ahead In State Exchanges (Pink Sheet)
  • Refill Reminder Programs May Be Next Free Speech Battleground For Pharma (Pink Sheet)
Medical Devices
  • 'The Sky's The Limit' For 3-D Printed Medical Devices, FDA Says (Gray Sheet)
  • Advocacy group unveils breakthrough diagnostics pathway (BioCentury) (BioCentury TV)
  • Two More Patients Potentially Exposed to Medtronic Device Contaminated With CJD (Reuters)
  • Implantable melanoma vaccine proceeds to human testing (Mass Device)
  • Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting (FDA)
  • June 2013 PMA Approvals (FDA)
  • Guided Therapeutics Receives Additional Questions from FDA for LuViva® Advanced Cervical Scan (GT)
Assorted And Government
  • Did FDA Just Announce A Major Reorganization? (Forbes)
  • CTTI holding private meeting on data transparency (BioCentury)
  • Foreign Regulator Training Only Provides Short-Term Gains, FDA Official Says (Pink Sheet)
  • US govt probes GSK's China activities (Pharma Times) (Law 360)
  • FDA Sets Targets For Food Center Priorities; New NDI Guide Expected This Year (IHP)
  • US Capitol Capsule: Vaccine makers take aim at an American killer: Seasonal flu (SCRIP)
Upcoming Meetings And Events
  • 9-10 September 2013: Joint Meeting of the Gastroenterology-Urology Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 9-10 September 2013: Pediatric Ethics Subcommittee Meeting (FDA) (FDA)
  • 10 September 2013: Pulmonary-Allergy Drugs Advisory Committee Meeting (FDA)
  • 11 September 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 12 September 2013: Oncologic Drugs Advisory Committee Meeting  (FDA)
  • 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 18 September 2013: ENVI Meeting, no Known Agenda as of Yet (ENVI)
  • 19 September 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19-20 September 2013: Pediatric Advisory Committee Meeting  (FDA) (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Germany's FDA: More deaths and side effects related to Bayer's Xarelto in 2013 (Reuters)
  • EMA workshop participants seek more flexible COI rules (BioCentury)
  • France Warns of Severe Adverse Events Associated With Amgen's Neupogen and Neulasta (ANSM)
  • Netherlands Moves to More Tightly Regulate Software as Medical Devices (MDL)

Asia

  • Expained: Proposed Legislation to Reform India's Drug Regulatory System (India Times)
  • Indian Clinical Trial Reforms Take Shape as Report Condemns HPV Vaccine Trials (In-Pharma)
  • Japan generics approvals set to up pressure on Zithromax, Valtrex (SCRIP)

Other International

  • WHO Pharmaceuticals Newsletter: Issue 4, 2013 (WHO)

General Regulatory And Interesting Articles

  • Compound interests: how a partnership between academics and a drug company came unstuck (BMJ)
  • Edible Silica Microtags: Eating Away at Counterfeit Drugs (In-Pharma)
  • Drug Cocktail That Protects Monkeys From Deadly Virus May Aid Humans (NYTimes)

Regulatory Reconnaissance #149 - 9 September 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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