Regulatory Focus™ > News Articles > Regulatory Reconnaissance (10 September 2013)

Regulatory Reconnaissance (10 September 2013)

Posted 10 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

  • FDA planning "significant" Tuesday opioid announcement (BioCentury)
  • FDA to review Merck's experimental fertility treatment (PBJ) (Merck) (SCRIP)
  • FDA Announces BE Draft Guidance for Advair Diskus (FDA) (Lachman Consultants) (FDA) (Pink Sheet) (Bloomberg)
  • A Primer on Compounding Pharmacies and Regulation by Congress (Roll Call) (Roll Call)
  • Another Compounding Pharmacy Recalls Products due to Third-Party Testing Concerns (FDA) (FDA)
  • Is the Malfunction MDR Reporting Requirement Unconstitutional? (FDA Law Blog)
  • FDA Panel Backs CT Colonography (MedPage Today)
  • Staff Changes at the FDA's Office of Regulatory Affairs: New Regulators and Shuffling Around the Attorneys (Policy and Medicine)

In Focus: International

  • ENVI Posts Draft Agenda for Upcoming Meeting, Including Regulation of Medical Devices and IVDs (ENVI)
  • Europe approves first biosimilar antibody drug (Reuters)
  • German regulator sees no new risks from Bayer's Xarelto (Reuters)
  • Serious Skin Reactions Reported With Pfizer's Sunitinib (Sutent) (MedScape) (SCRIP)
  • WHO implements fee changes to its Prequalification of Medicines Program (Pharma Letter)

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

US

Pharmaceuticals/Biotechnology
  • FDA planning "significant" Tuesday opioid announcement (BioCentury)
  • FDA to review Merck's experimental fertility treatment (PBJ) (Merck) (SCRIP)
  • FDA Announces BE Draft Guidance for Advair Diskus (FDA) (Lachman Consultants) (FDA) (Pink Sheet) (Bloomberg)
  • A Primer on Compounding Pharmacies and Regulation by Congress (Roll Call) (Roll Call)
  • Sarepta CEO: Next Eteplirsen FDA Meeting In October (The Street)
  • FDA grants orphan drug status to BioLine RX leukemia drug (MedCity News)
  • Another Compounding Pharmacy Recalls Products due to Third-Party Testing Concerns (FDA) (FDA)
  • Dangers From Compounding Pharmacies Persist (WSJ)
  • Positive response for Oncolytics' cancer virus program spurs share spike (Fierce)
  • Lower dose of Neurocrine's movement disorder drug fails in study (Reuters) (BioCentury) (SCRIP)
  • GSK, Teva Say Pay-for-Delay Lamictal Deal Doesn't Break Antitrust Law (Law 360)
  • Sandoz Agrees To Shelve Plans For Generic Zetia (Law 360)
  • Boehringer breathes easier as TIOSPIR 'confirms Respimat safety' (SCRIP)
  • Theraclone reports Phase IIa data for anti-flu mAb (BioCentury)
  • Afferent's AF-219 meets in Phase II for chronic cough (BioCentury)
  • Relmada Therapeutics Announces Positive Results of LevoCap ER Pivotal Pharmacokinetic Study (Relmada)
  • UCB Beats Apotex's IP Suit Over Drugmaking Process (Law 360)
  • FDA Accepts Biomedica's ClotFoam IND Application (DD&D)
Pharmaceuticals and Biotechnology: General
  • Schubert v. Genzyme Corp.: Drug Manufacturers Are under No Affirmative Duty to Sell Their Drugs (Drug and Device Law)
  • Crowded field of PhIII COPD contenders will compete for blockbuster market (Fierce)
Medical Devices
  • Is the Malfunction MDR Reporting Requirement Unconstitutional? (FDA Law Blog)
  • FDA Panel Backs CT Colonography (MedPage Today)
  • NanoString Wins FDA Approval of Breast Cancer Diagnostic Test (Xconomy) (Nanostring)
  • CardioMEMs' 2nd chance with the FDA is good news for backer St. Jude Medical (Mass Device)
  • More FDA hurdles for cervical scanning system sink Guided Therapeutic shares (Mass Device)
  • Melanoma Detection Device: Helping Doctors? Or Causing Dissent? (MedPage Today)
  • Access to Your Device Data? That'll be $797. (MDDI)
  • Intuitive Surgical says robot surgery complications study is 'misleading' (Mass Device)
  • J&J Watchdog Employee Can Proceed With Retaliation Lawsuit (Pharmalot)
Assorted And Government
  • HHS Rule Restricts Refill Reminders And Violates Free Speech: Lawsuit (Pharmalot) (Outsourcing Pharma)
  • Staff Changes at the FDA's Office of Regulatory Affairs: New Regulators and Shuffling Around the Attorneys (Policy and Medicine)
  • New NDIs Posted Online (NPI)
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) (FDA)
  • 9-10 September 2013: Pediatric Ethics Subcommittee Meeting (FDA) (FDA)
  • 10 September 2013: Pulmonary-Allergy Drugs Advisory Committee Meeting (FDA)
  • 10 September 2013: Patient Network Annual Meeting (FDA)
  • 10-11 September 2013: Global Summit on Regulatory Science and Nanotechnology (FDA)
  • 11 September 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 11 September 2013: Kidney Health Initiative (KHI)
  • 12 September 2013: Oncologic Drugs Advisory Committee Meeting  (FDA)
  • 12 September 2013: National Health Research Forum (Appearance by Margaret Hamburg) (Research America)
  • 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

  • ENVI Posts Draft Agenda for Upcoming Meeting, Including Regulation of Medical Devices and IVDs (ENVI)
  • Europe approves first biosimilar antibody drug (Reuters)
  • German regulator sees no new risks from Bayer's Xarelto (Reuters)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 2-5 September 2013 (EMA)
  • NICE consults on decision not to accredit BNF processes (RPS)
  • Non-Profit Leaves IMI Collaboration Over Glaxo Trial Transparency Stance (Pharmalot)
  • Sanofi, EU Medicines Agencies Flag Acquired Hemophilia Link To Clopidogrel (Pink Sheet)
  • iSonea asthma monitor gets CE Mark, no FDA yet (Mobi Health News)
  • Tenaxis Medical Gets Expanded CE Mark for ArterX Surgical Sealant (MedGadget)

Other International

  • Serious Skin Reactions Reported With Pfizer's Sunitinib (Sutent) (MedScape) (SCRIP)
  • WHO implements fee changes to its Prequalification of Medicines Program (Pharma Letter)
  • Regulatory Authorities Discuss Elemental Impurities Standards (PharmTech)
  • Kenyan patients being used as guinea pigs by researchers (Standard Media)

General Regulatory And Interesting Articles

  • A little better than placebo is still better than nothing (Nature)
  • Patient Groups/Pharma Relationships: Rife with Corruption or "Storm in a Teacup"? (Eye for Pharma)
  • Missing or Delayed Doses of Vaccine to Protect Against Pertussis Increase Whooping Cough Risk for Young Children (JAMA)

Regulatory Reconnaissance #150 - 10 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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