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

Regulatory Reconnaissance (9 August 2013)

Posted 09 August 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor is taking every Friday off in August for vacation, but is making sure to keep you up-to-date with Regulatory Reconnaissance.

In Focus: US

  • FDA Says it Wants to Study Effects of Abuse-Resistant Analgesic Formulations (FDA)
  • FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies (FDA)
  • Government Stakes Out a Standard that May Foreclose Many Federal False Claims Act Cases Based on Certain Alleged FDCA Violations (FDA Law Blog)
  • FDA Faces Dueling Demands On Antibiotic Clinical Trials (Law 360)
  • How FDA's Adverse Event Reporting System Impacts Drug Cos. (Law 360)
  • Measuring Pharma Innovation: Interview With FDA's Michael Lanthier (Burrill Report)
  • Won't be 'same ole, same ole' for ODAC at Upcoming Perjeta meeting (SCRIP) (FDA) (BioCentury)
  • FDA panel to discuss Paladin's leishmaniasis compound (FDA) (BioCentury)
  • Workgroup: Don't subject health IT to FDA pre-market requirements (Fierce)
  • Former Biotech CEO Asks Supreme Court To Review Free Speech Rights (Pharmalot)
  • Does an NDI notification open door for me-too ingredients? Answer: It depends (Nutra Ingredients)

In Focus: International

  • J&J gets green light for front-line Velcade in EU (Pharma Times) (Pharma Letter)
  • European Commission OK for Lonquex (Pharma Letter) (BioCentury)
  • China set to complete food and drug system reform this year, reports People's Daily (Pharma Letter)
  • India revokes patents on Allergan eye drugs Ganfort and Combigan (Reuters) (India Times)
  • Philippines looks to improve cell therapy regulation, support (SCRIP)
  • CFDA Head Says State-Local Rules Unification To Be Completed This Year (PharmAsia)
  • ICH Releases Details of June Meeting (ICH)

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

US

Pharmaceuticals/Biotechnology
  • FDA Says it Wants to Study Effects of Abuse-Resistant Analgesic Formulations (FDA)
  • Government Stakes Out a Standard that May Foreclose Many Federal False Claims Act Cases Based on Certain Alleged FDCA Violations (FDA Law Blog)
  • FDA Faces Dueling Demands On Antibiotic Clinical Trials (Law 360)
  • How FDA's Adverse Event Reporting System Impacts Drug Cos. (Law 360)
  • Cancer and orphan drugs drive increase in US NME approvals (Pharma Letter)
  • Measuring Pharma Innovation: Interview With FDA's Michael Lanthier (Burrill Report)
  • Won't be 'same ole, same ole' for ODAC at Upcoming Perjeta meeting (SCRIP) (FDA) (BioCentury)
  • FDA panel to discuss Paladin's leishmaniasis compound (FDA) (BioCentury)
  • Spectrum delays belinostat NDA submission on FDA feedback (SCRIP)
  • Judge To Review Cephalon Docs In FTC Pay-For-Delay Row (Law 360)
  • Citing CAFA, Industry Clamors to Keep Safety Suits in Mensing-Friendly Federal Court (FDA News)
  • Keryx seeks U.S. approval for Zerenex (BioCentury) (SCRIP)
  • Novo receives second CRL for rFXIII, reports 1H13 financials (BioCentury)
  • Novo says three year wait for Tresiba safety data (PMLive)
  • Novo Is On Track To File Liraglutide For Obesity By 2014 (Pink Sheet)
  • With early, obvious benefit of a targeted cancer drug, should expensive clinical testing continue? (EurekAlert)
  • Proposed FDA Study: Evaluation of Clinical and Safety Outcomes Associated with Conversion from Brand-Name to Generic Tacrolimus products in high risk Transplant Recipients (FDA)
  • FDA Approves Sandoz's ANDA for Griseofulvin (#91592) (FDA)
  • Ariad Unfazed By FDA Breakthrough Denial (Pink Sheet) (SCRIP)
  • Torrent recalls anti-psychotic tablet from US market (India Times)
  • U.S. reports malaria vaccine breakthrough (CNN) (NIH) (NPR) (MedPage Today)
  • Dana-Farber sees promise in leukemia vaccine trial (Fierce)
  • New Sign of Stimulants' Toll on Young (NYTimes)
Pharmaceuticals: General
  • Hanabusa staffer resigns after drug lobbying controversy (The Hill)
Medical Devices
  • FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies (FDA)
  • Workgroup: Don't subject health IT to FDA pre-market requirements (Fierce)
  • Wright Medical Group, Inc. Announces Receipt of FDA Not Approvable Letter for Augment Bone Graft (Wright)
  • Judge orders Zimmer to pay Stryker $228 million in patent case (Reuters)
  • Presentations from FDA's Workshop on Battery-Powered Medical Devices (FDA)
  • 'Smart' Pill Bottle Heads to Trials (DD&D)
  • LDR Receives FDA Approval for the Mobi-C Cervical Disc for One-Level Use (LDR)
  • Cordis recall of Optease vena cava filter is Class I (Mass Device) (FDA)
Assorted And Government
  • Former Biotech CEO Asks Supreme Court To Review Free Speech Rights (Pharmalot)
  • FTC Refunds Consumers $425,000 From Company Which Made False Claims About Vitamins (FTC)
  • IOM Launches Effort To Inform FDA Action On Caffeinated Products (IHP)
  • Does an NDI notification open door for me-too ingredients? Answer: It depends (Nutra Ingredients)
  • IOM Review Shows NIH Clinical and Translational Science Awards Program Contributes to Early Stage Advances in Medicine (Policy and Medicine)
Upcoming Meetings And Events
  • 5 August 2013: Webinar: Draft GFI On Expedited Programs For Serious Conditions Drugs And Biologics (FDA)
  • 5 August 2013: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 6 August 2013: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 15 August 2013: Alliance for a Stronger FDA/FDA International Programs Meeting (Strengthen FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

Asia

  • China set to complete food and drug system reform this year, reports People's Daily (Pharma Letter)
  • India revokes patents on Allergan eye drugs Ganfort and Combigan (Reuters) (India Times)
  • Philippines looks to improve cell therapy regulation, support (SCRIP)
  • CFDA Head Says State-Local Rules Unification To Be Completed This Year (PharmAsia)
  • ChinaGate: Sanofi Bribes Are Alleged; Authorities Visit Novo And Lundbeck (Pharmalot) (Law 360) (Bloomberg)
  • China Health Insurance To Pay Same For Proprietary, Generics: Sources (PharmAsia)
  • Ousted scientist fires back at GSK's high-pressure R&D strategy in China (Fierce)

Other International

  • ICH Releases Details of June Meeting (ICH)
  • AllTrials unveils updated manifesto for clinical trial transparency (PMLive)
  • Zimmer recalls knee implants over labeling concerns (Mass Device)
  • Colombian Regulators Simplify Translation, Grouping Rules for Medical Device Registration (Emergo)
  • Chiropractors In Australia Barred From Making Antivax Claims (Forbes)

General Regulatory And Interesting Articles

  • Electric Therapy for Medical-Device Malware (MIT Tech Review)
  • Voluntary Certification Schemes Not An Assurance of Excipient Quality, Says Expert (In-Pharma)
  • Scientists Disclose Plans To Make Superflu In Labs (NPR)
  • Best Way to Ensure Biomanufacturing Plants Have Quality? By Design (BioPharma-Reporter)

Regulatory Reconnaissance #128  - 9 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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