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

Regulatory Reconnaissance (13 August 2013)

Posted 13 August 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • Health Canada needs to regulate chemo cocktail supply: report (The Star) (Health Canada) (CTV)
  • More on the EU Approach to mHealth and e-labeling (MDL)
  • Japan Clinical Researchers Call For Stronger Regulation, Guidelines (PharmAsia)
  • Senior staff appointments and changes at Australia's TGA (TGA)
  • Electronic Informed Consent: Will it Increase Patient Knowledge on Trials? (Outsourcing Pharma)

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

US

Pharmaceuticals/Biotechnology
  • Breakthrough Therapy: Did FDA Just Do Its First Comparative Review? (Elsevier)
  • FDA approves new drug to treat HIV infection (FDA) (ViiV) (Pharma Times) (PMLive) (SCRIP) (Reuters) (Pharma Letter) (BioCentury) (Fierce) (Bloomberg)
  • Meetings: Pediatric Advisory Committee (FDA)
  • Vical dives as Melanoma Immunotherapy Drug Allovectin terminated on 'conclusive failure' (SCRIP) (Pharma Letter) (Fierce) (Pharma Times) (PMLive) (BioCentury) (Bloomberg)
  • Albany Molecular says Bristol-Myers stops development of depression drug (Reuters) (Pharma Times) (Outsourcing Pharma) (Pharma Letter) (BioCentury) (Fierce) (Bloomberg)
  • 8 Key cGMP Areas FDA Inspectors Seem to Focus On (FDAzilla)
  • An Otsuka Kidney Drug And A Researcher's Ironic Findings (Pharmalot)
  • Perrigo Announces FDA Final Approvals For The Generic Equivalents To Derma-Smoothe/FS Scalp Oil And Body Oil (Perrigo) (FDA)
  • Study reconfirms safety of flu vaccine in pregnant women (Fierce)
  • Video of 'lame' cattle stirs new concern over growth drugs (Reuters)
  • Sen. Alexander: Recall of Tainted Compounded Drugs in Texas Confirms "Congress Must Act Soon to Prevent Another Health Crisis" (Senate)
  • Anticipation builds before results of Lilly breast cancer study (SCRIP)
  • Merck Wants Fosamax Plaintiffs To Cough Up Evidence (Law 360)
  • Amgen 'neck and neck' with competitors in race for new anti-cholesterol drugs approval (MedCity News)
  • Grafix Demonstrates Overwhelming Efficacy in Landmark Stem Cell Study for the Treatment of Diabetic Foot Ulcers (Grafix)
Pharmaceuticals: General
  • Merchants of Meth: How Big Pharma Keeps the Cooks in Business (Mother Jones)
  • PCORI Chairman Washington To Step Down At The End Of 2013 (Pink Sheet)
  • Pharmaceuticals: Back to the lab to find personalized treatments (FT)
  • How Much to Develop a Drug? An Update. (In the Pipeline)
  • Meet the Top Ten Drugs of 2018 (Drug Channels)
  • An avant-garde approach to developing a disease-modifying drug for Alzheimer's (MedCity News)
Medical Devices
  • Meetings: Circulatory System Devices Panel of the Medical Devices Advisory Committee (FDA)
  • FDA rejection of Augment graft improves future for smaller companies (EP Vantage)
  • Investigational Device Pre-Decision Program Might Not Speed Up IDE Approvals (IHP)
  • Given Imaging Receives FDA Clearance for Next Generation PillCam(R) SB 3 (Given Imaging)
  • Class 1 Recall for Iradimed Corp's MRidium Infusion System; Can Give Incorrect Infusion Amount (FDA) (FDA)
Assorted And Government
  • Assessment of FDA's Final Guidance on Risk-based Monitoring (Polaris)
  • Harkonen Again Raises First Amendment Issues (FDA Law Blog)
  • AMA to shutter newspaper amid ad turmoil (MM&M)
Upcoming Meetings And Events
  • 15 August 2013: Alliance for a Stronger FDA/FDA International Programs Meeting (Strengthen FDA)
  • 16 August 2013: Risk Communication Advisory Committee (FDA)
  • 19 August 2013: FDA Basics Webinar: Biological Products, Part 2: Biosimilar Biological Products (FDA)
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • More on the EU Approach to mHealth and e-labeling (MDL)
  • Physician Payment Sunshine: Pan European Physician Payment Rules Begin January 1, 2015 (Policy and Medicine)
  • AMNOG comparator changes come into effect Tuesday (BioCentury)
  • First-of-a-kind once daily pill given regulatory green light for patients with rare type of skin cancer (MNT)

Asia

  • Japan Clinical Researchers Call For Stronger Regulation, Guidelines (PharmAsia)
  • Japan Hypertension Society Sets Up Ethics Committee In Response To Diovan Problem (PharmAsia)
  • Ono, Dainippon Sumitomo File For Approval Of Peripheral Circulation Drug Limaprost Alfadex In Japan (PharmAsia)
  • Mylan attempts to allay India's Agila concerns (SCRIP)

Other International

  • Health Canada needs to regulate chemo cocktail supply: report (The Star) (Health Canada) (CTV)
  • Senior staff appointments and changes at Australia's TGA (TGA)

General Regulatory And Interesting Articles

  • Electronic Informed Consent: Will it Increase Patient Knowledge on Trials? (Outsourcing Pharma)
  • Consumer Genetic Test Can Predict Your Drug Response (MIT Tech Review)
  • Near-death experiences may be surging brain activity (NBC)
  • China reports new H7N9 case; 1st new human infection in 3 weeks (SCRIP)

Regulatory Reconnaissance #130  - 13 August 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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