Regulatory Reconnaissance (25 October 2013)

Posted 25 October 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know:

In Focus: US

In Focus: International

US: Pharmaceuticals/Biotechnology

  • Conflict of interest charge leveled at FDA advisory panel chair (Pharmalot) (Pharmalot Follow-up) (Public Citizen) (Reuters) (Law 360-$)
  • FDA Advisers Unanimously Back J&J Hepatitis C Drug (Press) (AP) (Press) (SCRIP-$) (Pharma Letter-$) (Reuters) (BioCentury) (PMLive) (Fierce) (Pink Sheet-$) (Pharma Times) (Bloomberg)
  • FDA Absent From World Health Organization Biosimilar INN Discussions (IHP-$)
  • Comment Process on FDA's Proposed Rule on Product Detention During Inspections Reflects Industry Support (IPQ-$)
  • U.S. guidelines expand potential uses of J&J TB drug (Reuters)
  • FDA Taking Closer Look at Manufacturers' Visual Testing Programs While USP Would Set New Limits for Particles (Gold Sheet-$)
  • Merck Plans to Soon Submit BLA for 9-Strain HPV Vaccine (Merck)
  • Unichem gets FDA nod for generic hypertension tablets (India Times)
  • FDA Officials Clarify Expectations for New Reference Standards While Industry Says to Set Standards Late in Development (Gold Sheet-$)
  • Industry Needs to Drive the Dialogue Regarding FDA's Quality Metrics Initiative (PharmTech)
  • FDA says it is prepared for nanotechnology (The Hill) (FDA)
  • NPS submits Natpara BLA (BioCentury)
  • FDA Posts New MedGuides (FDA)
  • FDA Approves Addition to CIALIS (tadalafil) Product Label (Press)
  • Comments on H.R. 3204 by FDA's Dr. Ilisa Bernstein at PSM Interchange 13 (RxTrace)
  • Effexor Pay-For-Delay Suit Awaits High Court's K-Dur Answer (Law 360-$)
  • FDA Launches New "Bad Ad" Webpage (FDA)
  • CDC official: we've reached "the end of antibiotics" (Kottke)
  • FDA, Industry Look to Improve Investigations by Focusing on Systems, not Incidents (Gold Sheet-$)
  • FDA designates another Alexion drug a 'breakthrough' (SCRIP-$) (BioCentury) (DD&D) (Fierce)
  • Researchers Show Gout Drug Zyloprim Linked to Serious Hypersensitivity Reactions (DSM)

US: Pharmaceuticals and Biotechnology: General

  • Oxytrol OTC Success Depends On Driving Behavioral Changes (Tan Sheet-$)
  • DEA's Delay Not Too Long, Not Too Short, but Just Right to Escape a Writ of Mandamus: Court of Appeals Denies EISAI Petition to Order Scheduling of FYCOMPA (FDA Law Blog)
  • Watson Given DEA Nod to Import Amphetamines, Opioids (DEA)

US: Medical Devices

  • Government Shutdown Causes Backlog Of 100 Device Submissions, With More Expected (Gray Sheet-$)
  • FDA Warns (Again) About Decorative Contact Lenses and Their Risks (FDA)
  • FDA Does Not Approve of Napkin Sketches (MDDI)
  • Transcript: IDEs for Early Feasibility Medical Device Clinical Studies, Including First in Human (FIH) Studies (FDA)
  • Will preemption rescue Medtronic from InFuse lawsuits? (Mass Device)
  • Intuitive Surgical: The da Vinci robot still beats open surgery (Mass Device)
  • ILUMIEN OPTIS PCI Optimization System with FFR/OCT Approved for Use in U.S. (MedGadget)
  • Baxter warns on dialysis device (Mass Device)
  • The Good, The Bad, And The Ugly: Stents In The News (Forbes)
  • Agency Initiative Will Focus on Advancing Deep Brain Stimulation (Washington Post)

US: Dietary Supplements

  • Firm in outbreak probe has history of run-ins with FDA (USA Today)

US: Assorted And Government

  • An Independent Board To Oversee Clinical Trial Data Disclosure? (Pharmalot)
  • US Chamber of Commerce Calls For False Claims Act Reform (Law 360-$)
  • Urology association to launch clinical data registry (Modern Physician)

Upcoming Meetings And Events

  • 24-25 October 2013: Antiviral Drugs Advisory Commitee Meeting (FDA) (Day 2)
  • 31 October 2013: Data Harmonization for Patient-Centered Clinical Research (IOM/PCORI)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • Medicines safety experts call for rewrite of packaging Regulations (PharmaJournal)
  • NICE gives green light to Novartis' Lucentis for eye condition (Pharma Letter-$) (Pharma Times) (BioCentury) (PMLive) (SCRIP-$)
  • European Medicines Agency advises on compassionate use of sofosbuvir (EMA)
  • Batches of the insulin medicine NovoMix 30 FlexPen and Penfill to be recalled (EMA)
  • Hydroxyethyl-starch solutions (HES) should no longer be used in patients with sepsis or burn injuries or in critically ill patients - CMDh endorses PRAC recommendations (EMA)
  • Restrictions on use of short-acting beta-agonists in obstetric indications - CMDh endorses PRAC recommendations (EMA)
  • NICE sticks by no on Celgene's Revlimid (SCRIP-$)
  • UK pharma marketers still cagey about digital comms (SCRIP-$)
  • EU graft inquiry shifts to ex-health chief's overseas activity (EurActiv)
  • and TrialReach partner to give patients greater access to clinical trials, UK (MNT)


  • India Pharmas, U.S. FDA Agree On Talks, Workshops To Address Problems (PharmAsia-$)  (BioSpectrum)
  • Is Daiichi Sankyo Gearing Up For Arbitration Against Former Ranbaxy Owners? (PharmAsia-$)
  • Biocon planning Indian submission for biosimilar Herceptin (BioCentury)
  • Indian Supreme Court maintains hold on trials (BioCentury)

Other International

  • Canadian Agency Restores Funding To Drug Safety Group (Pharmalot) (Pharma Times)
  • Are Western sanctions against Iran to blame for playwright's death? (CNN)

General Regulatory And Interesting Articles

  • A simple fix to eliminate toxicity in 3-D printed medical implants (Fierce)
  • The Push for Data Transparency and Implications for Research (Bioethics Forum)
  • GSK sets up centre to develop greener drugs (PMLive)
  • Companies rush to build 'biofactories' for medicines, flavorings and fuels (Washington Post)
  • Why the U.K. Wants a Genomic National Health Service (MIT TR)

Regulatory Reconnaissance #187 - 25 October 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

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