Regulatory Focus™ > News Articles > Regulatory Recon: FDA Seeks Safety, Efficacy Data for OTC Hand Sanitizers; India Revises Draft Biosi

Regulatory Recon: FDA Seeks Safety, Efficacy Data for OTC Hand Sanitizers India Revises Draft Biosimilar Guidelines (30 June 2016)

Posted 30 June 2016 | By Michael Mezher 

Regulatory Recon: FDA Seeks Safety, Efficacy Data for OTC Hand Sanitizers India Revises Draft Biosimilar Guidelines (30 June 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • FDA approves implantable device that changes the shape of the cornea to correct near vision (FDA) (Press) (MassDevice)
  • New study sheds light on how some survive Ebola (CDC)
  • Analysis of 1976 Ebola outbreak holds lessons relevant today (NIH)
  • FDA seeks more data on over-the-counter hand sanitizers (Reuters) (FDA)
  • Pazdur to Head New Oncology Center at FDA (Focus) (Pink Sheet-$)
  • Can Esperion Therapeutics Ever Regain Wall Street's Trust? (Forbes) (BioCentury)
  • The Rocket Fuel for Biden's "Cancer Moonshot"? Big Data (MIT Technology Review)
  • FDA Advisory Committee Members and 'Appearance Issues' (FDA Voice) (Focus)
  • TransCelerate Progress on Trial Efficiencies Unimpeded by Pharma Regulator (Focus)
  • How J&J Defied Brexit and Became the Year's Top Health Care Stock (The Street)
  • Tesaro doubles after niraparib shows survival benefit (BioCentury) (Forbes)
  • Fatality in clinical trials: DIA panel discusses FIH trials (Outsourcing-Pharma)
  • Significant expansion of data available in the Genomic Data Commons (NIH)

In Focus: International

  • Regulator issues warning over small number of TRUEyou home-use blood glucose test strips (MHRA)
  • How Big Pharma misleads us: from painkillers to slimming pills (The Guardian)
  • Valeant Is Cash-Poor, and Even Bausch & Lomb Division May Not Save It (The Street)
  • European Regulatory Roundup: EC Opens Draft Consultation on Advanced Therapy GMP Guidelines (Focus)
  • Yellow fever outbreak: Sanofi looks to double vaccine production (BioPharma-Reporter)
  • Medical device companies fear parallel regulation after Brexit vote (MassDevice)
  • Brexit Could Boost Drug Costs for Britain's National Health Service (WSJ-$)
  • Indian Health ministry issues Revised Draft Guidelines on Similar Biologics (PharmaBiz)
  • China Food and Drug Administration Measures on Foods for Special Medical Purposes Take Effect (National Law Review)
  • CFDA Releases New Self-Assessment Reporting Requirements for Medical Device Distributors (Inside Medical Device)
  • EMA Says Drug Sponsors Struggle With Real-World Data, Adaptive Trials (FDA News-$)

US: Pharmaceuticals & Biotechnology

  • FDA Advisory Subcommittee Weighs in on Pediatric Oncology Candidates and Discusses Treatment Approaches for Fatal Pediatric Brain Tumor (Tarius)
  • Regulatory Flexibility For Rare Diseases: How Do You Routinize Elasticity? (Pink Sheet-$)
  • Biden slams cancer drug price increases (BioCentury)
  • Public Citizen Pushes FDA to Add Boxed Warning to Dopamine Agonist Drugs (FDA News-$)
  • Bristol-Myers Squibb's Response to ICER's Draft Scoping Document "Treatment Options for Advanced Non-Small-Cell Lung Cancer" (Press)
  • Event – Humira biosimilar faces its clinical hurdle (EP Vantage)
  • Merck holds parents accountable in new Gardasil ad campaign (Fierce)
  • Public-Private Partnerships Aim to Bolster 'Cancer Moonshot' Initiative (WSJ-$)
  • After 190 Tries, Are We Any Closer to a Cure for Alzheimer's? (Bloomberg)
  • Corning adds Biological Industries' xeno-free stem cell medium to portfolio (BioPharma-Reporter)
  • Parents' country of birth may influence vaccination rates for kids (Reuters)
  • GSK, Pfizer, AbbVie back next-gen integrin drugs in $52M Series A (Fierce)
  • Leukemia has largest pipeline, most first-in-class innovation in hematological cancers space (BioSpectrum)
  • Merck, Moderna in personalized cancer vaccine deal (BioCentury)
  • 5 Features To Look For In A Warning Letter (FDAZilla)
  • Harvard's Springer Gets $51.5M From Pharmas, Others, For Latest Startup (Xcconomy)
  • Biotech Stocks Facing FDA Decision In July (RTT News)
  • Cambridge diagnostic firm to double size of 'Moonshot' cancer database (Boston Biz Journal)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Bristol-Myers Squibb and PsiOxus Therapeutics Announce Immuno-Oncology Clinical Collaboration to Evaluate the Combination of Opdivo and Enadenotucirev (Press)
  • Poxel Announces Patient Enrollment Completed for Imeglimin Phase 2b Clinical Trial in Type 2 Diabetes in Japan (Press)
  • BioMarker Strategies Awarded Phase I/II Fast Track National Cancer Institute Grant to Develop Companion Diagnostic Test to Select Optimal Therapy for Patients with Non-Small Cell Lung Cancer (Press)
  • Xcovery Announces Initiation of Phase 3 Trial of X-396 in ALK+ Non-Small Cell Lung Cancer (Press)
  • Aratana Therapeutics Files for FDA Approval of NOCITA® (bupivacaine liposome injectable suspension) (Press)

US: Medical Devices

  • HeartWare Ventricular Assist Device (HVAD) Batteries by HeartWare Inc.: Class I Recall - Premature Power Depletion (FDA 1, 2)
  • Here's How Medtech Cyber Attacks Are Evolving (MDDI)
  • Sparo Labs gets FDA clearance for OTC device to help asthma patients track lung function (MedCityNews)
  • Nico touts studies using BrainPath to treat hemorrhagic stroke (MassDevice)
  • 'Program Alignment' Wants You: Why FDA Is Soliciting Input From Industry For New Facility Inspection Initiative (Gray Sheet-$)
  • NY State Clears Cancer Genetics NGS Lymphoma Panel (GenomeWeb)
  • JustRight Surgical first company to receive FDA clearance for use of device in pediatric patients (Press)
  • JustRight Surgical wins FDA 510(k) for 3mm pediatric vessel sealing system (MassDevice)
  • Concordia International Corp. Announces FDA Approval for New Photofrin Laser (Press)
  • FDA Supports Expanded Claims for Xpert Carba-R Test for "Superbugs" (Press)

US: Assorted & Government

  • GAO Releases Report Recommending that the DEA Take Additional Actions to Address Prior GAO Recommendations (FDA Law Blog)

Upcoming Meetings & Events


  • Nurofen TV ad is banned for being 'misleading' (OnMedica)
  • EU Device Approval Always a Win? Not So Fast (MDDI)
  • Roche Eyes Liquid Biopsy As A Boost To Drug Development And a New Monitoring Paradigm (Gray Sheet-$)
  • Porton replacing older facilities with new biopharma development plant (BioPharma-Reporter)
  • UK Govt Must Commit Strongly To Research During Brexit Talks, Says SciTech Committee (SCRIP-$)
  • Study: Initially CE Marked medical devices have higher recall rate (MassDevice)


  • Massive fake vaccine racket busted in Indonesia (Securing Industry)
  • Report: Japan OKs Canon's $6.5B Toshiba Medical buy, despite reservations (MassDevice)


  • Takeda India chief Aman Bajaaj resigns (Economic Times)
  • KMSCL to initiate action against Adroit Pharma for filing of forged documents; DC dept to take legal action (PharmaBiz)
  • IIPA urges DCGI sub-committee to set up registry of online pharmacies (PharmaBiz)
  • Alembic Pharma says plants successfully inspected by USFDA (Economic Times)


  • Dear Health Care Professional Letter – LYNPARZA (Health Canada)              


  • Zika sex research begins despite U.S. Congress funding impasse (Reuters)
  • Olympics will come and go but Zika is here to stay, scientists say (Reuters)

General Health & Other Interesting Articles

  • FDA Ruins Raw Cookie Dough for Everybody (NYTimes)
  • OECD Health Statistics 2016 (OECD)
  • Annual Decline in Heart-Disease Death Rates in U.S. Flat Since 2011 (WSJ-$)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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