Regulatory Focus™ > News Articles > Regulatory Reconnaissance (30 August 2013)

Regulatory Reconnaissance (30 August 2013)

Posted 30 August 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

  • J&J Tries New Cap To Curb Fatal Tylenol Overdoses (AP) (AP)
  • Industry Comments Roll in on Expedited Programs Guidance (Docket)
  • Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of Four Lots of Cubicin (Daptomycin for Injection) Due to Presence of Particulate Matter (Cubist) (FDA) (SCRIP) (Fierce)
  • Diet Pill Dilemma: Why Is FDA Approving Drugs When Europe Isn't? (NPR)
  • Stryker recalls spinal implant, gets 'deadly' FDA label (Fierce) (FDA)
  • Harvard Professor Blasts CDRH for Failure to Protect LASIK Patients (MDDI)
  • State Actions Grounded in "Source" Claims: Preempted or Not? (FDA Law Blog)

In Focus: International

  • UK's NICE, India's MHFW to Share Data (BioSpectrum)
  • CDSCO initiates steps to synergise regulatory activities with state drug regulatory bodies (PharmaBiz)
  • FDA Says it is not Targeting Indian Firms for Enforcement (India Times)
  • The MHRA's war on unlicensed drugs (C+D Mag)
  • NICE says 'yes' to Novartis' Jetrea (Pharma Times) (PMLive) (MNT) (SCRIP)
  • Bayer's Stivarga (regorafenib) Approved in the EU for the Treatment of Metastatic Colorectal Cancer (Bayer)
  • Australian Kalydeco decision 'deferred,' patients will fight but need a champion (SCRIP-Free)

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

US

Pharmaceuticals/Biotechnology
  • J&J Tries New Cap To Curb Fatal Tylenol Overdoses (AP) (AP)
  • Industry Comments Roll in on Expedited Programs Guidance (Docket)
  • Cubist Pharmaceuticals Issues Voluntary Nationwide Recall of Four Lots of Cubicin (Daptomycin for Injection) Due to Presence of Particulate Matter (Cubist) (FDA) (SCRIP) (Fierce)
  • Otsuka Receives Complete Response Letter from FDA for Tolvaptan for Use in Patients with Autosomal Dominant Polycystic Kidney Disease (Otsuka) (PMLive)
  • ReNeuron wins orphan status for stem cell therapy (PMLive)
  • FDA Approves Third Drug in BD Simplist Prefilled Injectable Line of Products (BD)
  • Diet Pill Dilemma: Why Is FDA Approving Drugs When Europe Isn't? (NPR)
  • WLF: The Federal Circuit Should Rehear Novo Nordisk v. Caraco Ruling En Banc (Forbes)
  • InVivo Therapeutics suffers from FDA's timidity on biologic grafts (EP Vantage)
  • Takeda Sues Mylan Over Generic Acid Reflux Drug (Law 360)
Pharmaceuticals: General
  • Federal judge rules in favor of Alameda drug take-back ordinance (SF Biz Journal)
  • Pharma Security Experts Urge Extra Vigilance Over Holiday Weekend (FDA News)
  • Drug substitution can triple savings for payers: US report (Pharma Times)
  • University of Louisville Accepting Patients in Study of C. diff Vaccine (ICT)
  • Drugmakers may sue L.A. boutique over Adderall, Vicodin, Xanax T-shirts (NYDN)
Medical Devices
  • Stryker recalls spinal implant, gets 'deadly' FDA label (Fierce) (FDA)
  • Harvard Professor Blasts CDRH for Failure to Protect LASIK Patients (MDDI)
  • PFM Medical lands FDA approval for heart plug (Mass Device)
  • FDA/AAO Workshop on Developing Novel Endpoints for Premium Intraocular Lenses, October 11, 2013 (FDA)
  • CDRH Seeks Audit and Inspection Data System (FDA)
  • Cardium takes another swing at FDA clearance for wound care product (Mass Device)
  • LipoScience back to drawing board after FDA rebuff (Fierce)
Assorted And Government
  • State Actions Grounded in "Source" Claims: Preempted or Not? (FDA Law Blog)
  • What's the future of drug policy? An interview with America's 'Drug Czar' (Washington Post)
  • ABA releases third edition to FCPA handbook (Inside Counsel)
  • Justice Department Announces Update to Marijuana Enforcement Policy, Will Permit Some State-Level Discretion (DOJ)
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

  • The MHRA's war on unlicensed drugs (C+D Mag)
  • NICE says 'yes' to Novartis' Jetrea (Pharma Times) (PMLive) (MNT) (SCRIP)
  • Bayer's Stivarga (regorafenib) Approved in the EU for the Treatment of Metastatic Colorectal Cancer (Bayer)
  • EC approves new Eylea indication (BioCentury)
  • UK turns up heat on deadly fat burner (Nutra Ingredients)
  • Stem cell 'vehicle' gets human trial approval in Spain (BioSpectrum)

Asia

  • UK's NICE, India's MHFW to Share Data (BioSpectrum)
  • CDSCO initiates steps to synergise regulatory activities with state drug regulatory bodies (PharmaBiz)
  • FDA Says it is not Targeting Indian Firms for Enforcement (India Times)
  • More Indian Companies Suspending Enrollment in Trials, Reportedly Due to Current CDSCO Rules (PharmaBiz)
  • Daiichi Sankyo Seeks New Japanese Ranmark Approval (DD&D)
  • CFDA Reviews Laws To Promote Pharma E-Commerce: Sources (PharmAsia)
  • Aus disinfection technology gets Korea FDA nod (BioSpectrum)

Other International

  • Australian Kalydeco decision 'deferred,' patients will fight but need a champion (SCRIP-Free)
  • New device maintenance fee schedule announced in Argentina (Mass Device)

General Regulatory And Interesting Articles

  • Should You Consider a Career in Regulatory Affairs? (MDDI)
  • Google Ventures bets on oral biologics from startup Rani Therapeutics (Fierce) (SCRIP)
  • How Access to Life-Saving Antisera is Dwindling Fast, and What to do About it (PLoS)

Regulatory Reconnaissance #143  - 30 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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