Regulatory Focus™ > News Articles > Regulatory Recon: FDA Beats Its Expectations on ANDA Backlog (19 October 2015)

Regulatory Recon: FDA Beats Its Expectations on ANDA Backlog (19 October 2015)

Posted 19 October 2015 | By Michael Mezher 

Regulatory Recon: FDA Beats Its Expectations on ANDA Backlog (19 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 approves Praxbind, the first reversal agent for the anticoagulant Pradaxa (FDA) (Press) (SCRIP-$)
  • FDA Ahead of Schedule to Reduce ANDA Backlog, Agency Says (FDANews-$) (SCRIP-$) (Pink Sheet-$)
  • To Reduce the Cost of Drugs, Look to Europe (NYTimes)
  • FDA Nominee Robert Califf Connected Faculty with Industry (The Intercept)
  • Zarxio Rehearing Denied; Biosimilar Questions Await Next Case (SCRIP-$) (Patent Docs) (Law360-$) (Pink Sheet-$)
  • FDA eye drug rebuff adds to Shire's woes in Baxalta pursuit (Reuters) (Press)
  • Theranos, a Blood Test Start-Up, Faces F.D.A. Scrutiny (NYTimes) (Washington Post)
  • Valeant Responds to Price Critics, May Sell Neurology Drugs Unit (Bloomberg)

In Focus: International

  • Faster EU Drug Assessment Pathway Could Launch In First Quarter 2016 (Pink Sheet-$)
  • FDA Mutual Reliance With EU On Inspections Is Slow Going (Pink Sheet-$)
  • CDSCO begins Induction Programme for assistant drug inspectors to upgrade technical, professional & other functional skills (PharmaBiz)
  • Biosimilar discounts and switching will wipe-out J&J's Remicade in Norway, says regulator (BioPharma-Reporter)
  • EMA Orphan Chief On Smart Strategies For Companies (Pink Sheet-$)

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US: Pharmaceuticals and Biotechnology

  • Cempra tumbles on safety concerns of anti-bacterial drug (Reuters) (BioSpace)
  • Google Platform Changes Spur Pharma Rethinking Of Search Engine Ads (Pink Sheet-$)
  • FDA Review Of Novartis' Entresto Shows Agency's Practical Side (Pink Sheet-$)
  • Who Makes This Drug? Disclosing The Identity Of Generic Drug Manufacturers (HealthAffairsBlog)
  • Researchers request FDA pull ineffectual decongestant off the market (DSN)
  • Study quantifies human consequences of increased antibiotic resistance (OnMedica)
  • Cancer Drug Comparisons Released By NCCN, Include Affordability (Pink Sheet-$)
  • Neuroblastoma Genomic Discovery Gateway To Potential Therapies (SCRIP-$)

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

  • Pfizer’s Inotuzumab Ozogamicin Receives FDA Breakthrough Therapy Designation for Acute Lymphoblastic Leukemia (ALL) (Press)
  • Genocea Announces Top-Line Results from Phase 2a Trial for Universal Pneumococcal Vaccine Candidate GEN-004 (Press)
  • La Jolla Pharmaceutical Company Doses First Patient in Phase 1 Clinical Trial of LJPC-401 in Patients at Risk of Iron Overload (Press)
  • Seattle Genetics Initiates Phase 2 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) Combination Therapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) (Press)
  • Phase 2 Maintenance Data from Oral Ozanimod TOUCHSTONE Study in Ulcerative Colitis Presented at ACG Plenary Session (Press)
  • Lenvatinib Phase II results show significant improvement in progression-free survival when used with everolimus in metastatic renal cell carcinoma (MNT)
  • Phase II Trial Results on Novel Anticancer Agent Lenvima® in Renal Cell Carcinoma Published in Lancet Oncology (Press)

US: Medical Devices

  • Apple Announces New ResearchKit Studies for Autism, Epilepsy & Melanoma (Apple) (Popular Science)
  • New Report Finds Improvement In FDA Medical Device Review Times (MedDeviceOnline) (Press)
  • FDA asks for comment on Administrative Detention and Banned Medical Devices (FDA)
  • Comment Request; Guidance on Reagents for Detection of Specific Novel Influenza A Viruses (FDA)
  • Johns Hopkins launches epilepsy study using Apple Watch (MassDevice)
  • Roche receives FDA approval for viral load tests and cobas 6800/8800 Systems (Press)
  • FDA approves first focused ultrasound system for treating the prostate (MNT)
  • Stryker's VertaPlex HV First PMMA To Receive Clearance For Treating Sacral Insufficiency Fractures (MedDeviceOnline)
  • Orfit wins CE Mark, FDA 510(k) for immobilization system (MassDevice) (Press)
  • Pacemakers identify atrial fibrillation and enable initiation of stroke prevention (MNT)
  • Stryker wins FDA expanded clearance for VertaPlex HV (MassDevice)

US: Assorted and Government

  • Senate ‘Innovation’ Bill Being Narrowed With Year-End Committee Passage In Mind (Tan Sheet-$)
  • FDA Removes Pacira Warning Letter Amid Free Speech Suit (Law360-$)
  • J&J Wins First Tylenol Liver Damage Trial (Law360-$)

Upcoming Meetings and Events              


  • EMA Rules Of Industry Engagement Take Centralized Approach (Pink Sheet-$)
  • Faster EU Drug Assessment Pathway Takes Shape: Convergence With US Breakthrough Designation On the Cards (SCRIP-$)
  • UVLrx 1500 Intravascular Light Therapy System Gains CE Mark (medGadget)
  • MHRA Annual accountability review (MHRA)


  • AICDF urges NPPA to take punitive action against cos for violating provisions of DPCO (PharmaBiz)
  • Katoch committee on API asks govt to initiate measures for stronger industry-academia interaction (PharmaBiz)


  • BMS Bolsters China Compliance In Wake Of SEC Fine (PharmAsiaNews-$)


  • Australia to allow marijuana to be grown locally for medical trials (Reuters)

Other International

  • Malaysia's Mediven gets CE-IVD certification for molecular test kits (BioSpectrum)

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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