Regulatory Focus™ > News Articles > Regulatory Reconnaissance (26 August 2013)

Regulatory Reconnaissance (26 August 2013)

Posted 26 August 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Fresenius receives third FDA warning to improve procedures at its sites (Reuters) (Law 360)
  • Keywords Not Major Advertising Enforcement Concern, FDA Says (Pink Sheet)
  • The Story Behind FDA's Rejection of Aveo's Kidney Cancer Drug Tivozanib (Boston Globe)
  • At CDER and CBER … Three Positives and Three Concerns (Strengthen FDA)
  • First Post-FDAAA "New Active Ingredient" Election and Grant of NCE Exclusivity Made With the Approval of Fetzima (FDA Law Blog)
  • GSK/ChemoCentryx Crohn's Failure May Sink Hefty Phase III Program (Pink Sheet) (GSK) (Fierce) (BioCentury) (Reuters) (SCRIP)
  • Traceable Supply Chain Is "End Game" To Stop Counterfeits, FDA Risk Advisor Says (Pink Sheet)
  • HIT Workgroup Calls For More FDA Action, Sidesteps Funding Questions (IHP)
  • USPlabs, GNC DMAA Controversy Highlights FDA's Detention Powers (NPI)

In Focus: International

  • New leadership team at EMA to be unveiled in September (Pink Sheet)
  • Russia to join global initiative for recognizing single medical device audit (Clinica)
  • Australia To Double-Check Efficacy Of Expensive Covered Drugs (PharmAsia)

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

US

Pharmaceuticals/Biotechnology
  • Fresenius receives third FDA warning to improve procedures at its sites (Reuters) (Law 360)
  • Keywords Not Major Advertising Enforcement Concern, FDA Says (Pink Sheet)
  • The Story Behind FDA's Rejection of Aveo's Kidney Cancer Drug Tivozanib (Boston Globe)
  • At CDER and CBER … Three Positives and Three Concerns (Strengthen FDA)
  • First Post-FDAAA "New Active Ingredient" Election and Grant of NCE Exclusivity Made With the Approval of Fetzima (FDA Law Blog)
  • GSK/ChemoCentryx Crohn's Failure May Sink Hefty Phase III Program (Pink Sheet) (GSK) (Fierce) (BioCentury) (Reuters) (SCRIP)
  • Sanofi trial shows Fluzone high-dose flu vaccine efficacy (Reuters)
  • Many Drugs Found Safe for Breast-Feeding Mothers (WSJ)
  • FDA Eyes Expansion Of Question-Based CMC Reviews To New Drugs (Pink Sheet)
  • Traceable Supply Chain Is "End Game" To Stop Counterfeits, FDA Risk Advisor Says (Pink Sheet)
  • Ceptaris Receives FDA Approval for Valchlor (mechlorethamine) Gel for the Treatment of Stage IA and IB Mycosis Fungoides-Type Cutaneous T-Cell Lymphoma in Patients Who Have Received Prior Skin-Directed Therapy (Ceptaris)
  • Galderma Receives FDA Approval of Mirvaso for Facial Erythema of Rosacea (Galderma)
  • Depomed Says It Was Cheated Out Of Orphan Drug Exclusivity (Law 360)
  • Study: Evaluating and Adjusting for Premature Censoring of Progression-Free Survival (Journal of Biopharm Stats)
  • Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection (FDA)
  • NIH responds to advocacy group's concerns over study of anemia treatment for premature infants (Reuters) (NPR)
  • Special Protocol Assessment For Navidea's Parkinson's Diagnostic Could Help With Coverage (Pink Sheet)
  • FDA Submits Pet Event Tracking Network (PETNet) and LiveStockNET for OMB Approval (FDA)
  • Rigel's R343 Did Not Meet Primary Endpoint in Asthma Study (Rigel)
  • FDA Contract: Study on Genetic characterization of HIV-1 strains from Cameroon (FDA)
Pharmaceuticals: General
  • Drug Shortages: New Ones Down, Old Ones Persist (MedPage Today)
  • Amgen to Buy Onyx for $10.4 Billion to Gain Cancer Drug (Bloomberg)
  • Why Good Drugs Sometimes Fail: The Bexxar Story (Xconomy)
  • DEA Approves Navinta's Application to Manufacture Pentobarbital, Remifentanil (DEA)
  • 50% of all drug firms have counter-generics team (BioSpectrum)
  • Research Shows Physicians Resistant To Prescribing 'Costly' Abuse Deterrent Opioids (IHP)
Medical Devices
  • HIT Workgroup Calls For More FDA Action, Sidesteps Funding Questions (IHP)
  • The International Registry Infrastructure for Cardiovascular Device Evaluation and Surveillance (JAMA)
  • When Medical Device Batteries Go Bad (Gray Sheet)
  • Reverse Medical lands FDA OK for micro vascular plug (Mass Device)
  • Zimmer Receives FDA Clearance For Patient Specific Instruments (PSI) Shoulder (Zimmer)
Assorted And Government
  • USPlabs, GNC DMAA Controversy Highlights FDA's Detention Powers (NPI)
  • NIH Relases Newly Revised Guiding Principles on Biomedical Research Involving Animals (NIH)
  • Publication of Results of EFPIA-PhRMA commissioned Patient Stakeholder survey (EFPIA)
  • US Capitol Capsule: US anti-bribery actions 'next shoe' in China scandal? (SCRIP)
  • Recommendations for Improving Informal Rulemaking (RegBlog)
  • Docs brace for sunshine as industry gifts go public (Fierce)
  • Obama pushes back against regulation criticism (The Hill)
  • Debt ceiling drama underway (Politico)
Upcoming Meetings And Events
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • 4-5 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (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

  • New leadership team at EMA to be unveiled in September (Pink Sheet)

Asia

  • Russia to join global initiative for recognizing single medical device audit (Clinica)
  • India: Campaign demands fast-track approval for biosimilars of breast-cancer drug Trastuzumab (PharmaBiz)
  • As China bribery scandal widens, Lilly other US drug makers tout oversight (SCRIP)

Other International

  • Australia To Double-Check Efficacy Of Expensive Covered Drugs (PharmAsia)

General Regulatory And Interesting Articles

  • How to Charge $546 for Six Liters of Saltwater (aka IV Bags) (NYTimes)

Regulatory Reconnaissance #139  - 26 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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe