Regulatory Focus™ > News Articles > Regulatory Recon: Dispensers Get Four Months Reprieve from DSCSA Enforcement (30 October 2015)

Regulatory Recon: Dispensers Get Four Months Reprieve from DSCSA Enforcement (30 October 2015)

Posted 30 October 2015 | By Michael Mezher 

Regulatory Recon: Dispensers Get Four Months Reprieve from DSCSA Enforcement (30 October 2015)

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 Extends Dispenser Delay in DSCSA Enforcement (RxTrace) (PharmPro) (FDA)
  • Former Warner-Chilcott president arrested for alleged kickback scheme (Pharmalot) (WSJ) (Law360-$) (DoJ)
  • Valeant , Express Scripts & CVS Health Cut Ties With Philidor (Valeant) (NYTimes 1, 2) (WSJ)
  • When Buying Pharmacies, Valeant Affiliates Haven’t Disclosed California License Denial (ProPublica)
  • White House issues report on improving biosafety at federal labs (Reuters)
  • This Is What We Should Learn From Theranos (Forbes)

In Focus: International

  • CDSCO drug inspectors to get online training on GMP for pharma & medical devices (PharmaBiz)
  • Question and Answer with Tara Prasad, Research Programme Manager at Access to Medicines Index (PharmaAfrica)
  • SPC manufacturing waiver urgently needed to stimulate pharmaceutical manufacturing in Europe (EGA)
  • Two clients of Dr Reddy's saw revocation of ANDAs (Economic Times)

US: Pharmaceuticals and Biotechnology

  • FTC raises anticompetitive concerns about FDA naming proposal for biosimilars (Pharmalot) (FDA Law Blog) (Focus)
  • FDA Crisis Management: Behind-The-Scenes Of Josh Hardy's Compassionate Use (Pink Sheet-$)
  • Vertex Gears Up For Next Generation In CF Therapy (SCRIP-$)
  • Sanofi Recalls Auvi-Q Allergy Injectors (WSJ)
  • Glowing terms often used for new cancer drugs in health news (Reuters) (Washington Post) (NPR)
  • Imprimis Pharmaceuticals to Register with the FDA as an Outsourcing Facility (PharmPro)
  • Novartis, Juno face production hurdles for new blood cancer drugs (Reuters)
  • Why the FDA Is Worried About Chinese Drugs in Your Medicine Cabinet (Bloomberg)
  • Potential New Broad-Spectrum Antibiotic (PharmPro)
  • The Viekira Pak Effect – Will it Change P&T Practices for Good? (RxView Blog)
  • Biosimilar naming and AE reporting (GaBI)
  • Paying For Value In Cancer Care (HealthAffairsBlog)
  • Aspirin: is it really a 'wonder drug'? (MNT)
  • Telemedicine Making Drug Trials Cheaper And Quicker (Forbes)

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

  • BioBlast sets sights on PhIII after efficacy prompts early halt of mid-stage study (FierceBiotech) (Press)
  • Revance rises on Phase II data for Botox competitor (BioCentury)
  • New Opioid Combo Tab Demonstrates Efficacy for Pain, OINV (MPR)
  • Third of men with advanced prostate cancer could benefit from olaparib (Pharmaceutical Journal-$)
  • FDA approves new Novartis dual combination bronchodilator Utibron™ Neohaler® for patients with chronic obstructive pulmonary disease (Press)
  • Insys Therapeutics Announces Its Naloxone Sublingual Spray Received Fast Track Designation From the FDA for the Treatment of Opioid Intoxication or Overdose (Press)

US: Medical Devices                        

  • House Committee Reschedules Meeting on Diagnostic Tests and Laboratory Operations (E&C)
  • A Peek at the Next 510(k) Modifications Guidance (MDDI) (SCRIP-$)
  • Myocardial Protection System (MPS) Delivery Sets by Quest Medical: Recall (FDA 1, 2)
  • GlucoTrack® Moves Forward with FDA Approval Process (Press)
  • PathMaker Neurosystems Inc. Receives Expedited Access Pathway Designation from FDA for MyoRegulator (Press)
  • FDA Clears Masimo MightySat Personal Pulse Oximeter with SET Measure-through Motion and Low Perfusion (medGadget)

US: Assorted and Government

  • BioPharm companies are Inviting Price Controls By Inaction (DrugWonks)
  • How Government Policy Promotes High Drug Prices (HealthAffairsBlog)
  • Doctor indicted for taking kickbacks and giving drug maker patient data (Pharmalot)
  • Warning Letter? What Warning Letter? . . . Latest Developments in Pacira and a Look at FDA’s History of Withdrawing Warning Letters (FDA Law Blog)
  • Psychology and Physiology of the Biotech Markets Today (LifeSciVC)
  • Supplement Firms Making Drug Claims On Fast Track To Notoriety At FDA (Tan Sheet-$)
  • Genentech Dodges FCA Claims Over Avastin's Side Effects (Law360-$)
  • US generics makers slam House budget plan (PharmaLetter-$)
  • AstraZeneca Says Dr. Reddy's Heartburn Pill Can't Be Purple (Law360-$)
  • Does it make sense for Pfizer to buy Allergan? What the wags say… (Pharmalot)
  • New York to require extra training to prescribe medical marijuana (CBS News)
  • Top 50 Pharmaceutical Companies Focus Headcount on Regional Managed Markets Account Managers (Cutting Edge Info)
  • Boston Scientific settles Salazar pelvic mesh lawsuit (MassDevice)

Upcoming Meetings and Events              

Europe

  • Celgene gets Europe's nod for acute myeloid leukaemia drug (BioSpectrum)
  • EU First, US Second For Product Launch? Not Necessarily, Says French Investor (Gray Sheet-$)
  • European Medicines Agency closed 2 November 2015 (EMA)

Canada

  • Sanofi Canada Issues Voluntary Nationwide Recall of Allerject® Due to Potential Inaccurate Dosage Delivery (Press)

India

  • CDSCO's clarification regarding import & registration of cosmetics in addition to existing guidelines (PharmaBiz)
  • India needs database of blood stem cell donors: Doctor (Economic Times)
  • Glenmark gets tentative US FDA nod for Lacosamide tablets (Economic Times)
  • Dr Reddy's plans bigger push on biosimilars in emerging markets (Economic Times)

Japan

  • PMDA October Update (PMDA)

Ebola Outbreak

  • Deforestation 'may have started west Africa's Ebola outbreak' (EurActiv)
  • Study: Funerals Were Prime Places for Ebola Spread (MedpageToday)

Other International

  • ICH Reformed At Last, Expects More Drug Regulators To Join In (SCRIP-$) (Focus)

General Health and Other Interesting Articles

  • Teenage girl in Oregon hospitalized with bubonic plague (Reuters)
  • Zombie contact lens leaves Michigan teen partially blind (CBS News)
  • NIH researchers link single gene variation to obesity (NIH)
  • Researchers' Discovery Could Be Key to Developing a Vaccine Against Toxoplasma (ICT)

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 news@raps.org.

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


Categories: Recon, Regulatory News

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