Regulatory Focus™ > News Articles > Regulatory Recon: FDA Investigating New Complaints Against Theranos, Sun Pharma Gets Warning Letter

Regulatory Recon: FDA Investigating New Complaints Against Theranos, Sun Pharma Gets Warning Letter (21 December 2015)

Posted 21 December 2015 | By Michael Mezher 

Regulatory Recon: FDA Investigating New Complaints Against Theranos, Sun Pharma Gets Warning Letter (21 December 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

  • US health regulators probe Theranos complaints (Reuters) (WSJ-$) (NYTimes)
  • Amgen Denies Rumors About PCSK9 Inhibitors (CardioBrief)
  • How a medical device maker kept U.S. hospitals in the dark about deadly infections (LA Times)
  • Beyond Fitbit: The quest to develop medical-grade wearables (Reuters)
  • One Pharma Fix: Limit the 'Orphan Drug' Incentives (WSJ-$)

In Focus: International

  • India's Sun Pharmaceutical Gets FDA Warning (WSJ-$) (Reuters 1, 2)
  • Nine drugs recommended for approval by EMA/CHMP, 93 overall in 2015 (PharmaLetter-$)
  • CDSCO to review guidelines on biosimilars to meet healthcare needs (PharmaBiz)
  • EMA Defends PRIME's Early Entry Advantage For SMEs (SCRIP-$)

US: Pharmaceuticals and Biotechnology

  • FDA approves Keytruda for first-line melanoma (BioCentury)
  • Skepticism About Study Linking Antidepressants And Autism (Forbes)
  • US-Canada Pilot Could Help FDA's OTC Monograph Update Fly (Tan Sheet-$)
  • PCSK9 Sponsors Looked For Regulatory Advantages In Race To Market (Pink Sheet-$)
  • Labelling survey reveals deep inefficiencies (In-PharmaTechnologist)
  • Biosimilar Market Formation Isn't Going According To Plan (Pink Sheet-$)
  • The Califf Factor: Commissioner Nominee's Role In IMPROVE-IT Gets Notice (Pink Sheet-$)
  • Heartburn drugs affect gut bacteria, which may promote infection (Reuters)
  • Drisapersen Advisory Committee Is Rough Welcome To FDA For Patient Groups (Pink Sheet-$)
  • AstraZeneca hit with setback as durvalumab falls further behind on lung cancer (FierceBiotech)

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

  • Avisa's Biomarker Breath Test Detects Tuberculosis in South Africa Pilot Study (Press)
  • Boehringer Ingelheim 3rd-generation EGFR TKI, BI 1482694, receives FDA Breakthrough Therapy Designation in lung cancer (Press)
  • FDA Approves Expanded Indication for Merck's KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Advanced Melanoma (Press)
  • Neurelis Receives FDA Orphan Drug Designation for NRL-1 in the Treatment of Acute Repetitive Seizures (Press)
  • Adaptimmune initiates Phase I/II T-cell therapy study in NSCLC (EPR)
  • Celyad Receives Clearance from the US FDA on Its CHART-2 Phase III IND (Press)

US: Medical Devices

  • FDA Plans to Issue Final LDT Framework in 2016; Subcommittee Members, CMS and FDA Officials Critique Proposed Legislative Approach that Would Give CMS LDT Premarket Review Authority (FDA Law Blog)
  • US FDA Kills Voluntary ISO Audit Program For Medtech As MDSAP Efforts Accelerate (SCRIP-$) (Focus)
  • Charting A Regulatory Course For Your Combination Product (Med Device Online Pt 1, Pt 2)
  • FDA approves fecal incontinence system via Humanitarian Exemption (FierceMedicalDevices) (MassDevice)
  • New infectious disease test promises quick diagnosis (MNT)
  • FDA clears Life Spine's Gruve cervical plate implant (MassDevice)
  • FDA Expected To Add Value To Wearable Medical Device Market (MedDeviceOnline)
  • Luminex Receives FDA Clearance for NxTag Respiratory Pathogen Panel (GenomeWeb)
  • Instrumentation Laboratory Receives US FDA Clearance For New ACL TOP® Family 50 Series Hemostasis Testing Systems (Press)
  • Thermo Fisher Scientific Receives FDA Clearance for New Allergen Component Tests for Hazelnut, Walnut and Cashew Nut IgE Sensitization (Press)

US: Assorted and Government

  • Editorial: No Justification for High Drug Prices (NYTimes)
  • HP&M's Jeff Shapiro Addresses FDA's Role in Digital Health Regulation: Unclear and Evolving (FDA Law Blog)
  • Supreme Court Ought to Re-examine Second-Guessing of FDA-Approved Drug Labeling by State Tort Law (WLF Legal Pulse)
  • N.D. Mississippi Says "Bah, Humbug!" to Discovery on Devices Not Used (Drug and Device Law)
  • Democrats hint at CMS drug cost policies (BioCentury) (Letter)
  • The U.S. Pays a Lot More for Top Drugs Than Other Countries (Bloomberg)
  • Rx Drug Price Measure Qualifies for 2016 California Ballot (California Healthline)
  • Obama signs medical device tax pause into law (MassDevice)
  • Isis Pharma changes 'unfortunate' name to avoid confusion (Reuters)
  • HHS Study On Drug Price Increases, Costs, Access Required In Funding Bill (Pink Sheet-$)
  • Opioid abuse propels record U.S. deaths from overdose: CDC (Reuters)
  • GAO: FDA's strategic health IT plan lacks key elements (FierceHealthIT) (Bloomberg) (GAO)
  • Novartis sees different drug pricing models: CEO in NZZ am Sonntag (Reuters)
  • Martin Shkreli Says Drug-Price Hikes Led to Arrest (WSJ-$)

Upcoming Meetings and Events              


  • "Our commitment to patients' welfare will continue to guide our work in 2016" (EMA)
  • All Change As EMA Management Board Chair And Deputy Director Bid Farewell (SCRIP-$)
  • EMA warns of PML, cancer risks from Novartis' Gilenya (FiercePharma) (EMA)
  • CHMP backs Tagrisso, Portrazza, Zurampic (BioCentury)
  • New policy on Netherlands' implementation of DHPCs (PharmaLetter-$)


  • Granules India facility gets three observations during USFDA audit (Economic Times)
  • India's New Draft Patent Rules Feed Into Modi's Make in India Ambitions (24 Insight)
  • Pfizer Reaches Trademark Settlement With Cadila on Viagra in India (24 Insight)
  • Strides Shasun gets DCGI nod to manufacture Hepatitis C drug (Economic Times)
  • Glenmark Pharmaceuticals settles patent litigation over anti-depressant drug (Economic Times)
  • New medicine for Hepatitis C treatment launched (Economic Times)



  • OphthaliX secures patent from Japan for intraocular pressure therapeutic (BioSpectrum)
  • Japan's Astellas back in the doghouse with U.K. marketing watchdog (FiercePharmaAsia-$)
  • Bristol-Myers, Ono initiate Rheumatoid Arthritis drug study in Japan (BioSpectrum)
  • Oral REVLIMID® Plus Dexamethasone Granted Approval for Treatment of Patients with Newly Diagnosed Multiple Myeloma in Japan (Press)


  • GMP clearance application process improvements (TGA)
  • Guidance for new registered complementary medicine applications (TGA)

Other International

  • Singapore researchers ID path for predicting drug resistance (FiercePharmaAsia)
  • Singapore incubator inks med-tech development deal (MassDevice)

General Health and Other Interesting Articles

  • A Prescription for Confusion: When to Take All Those Pills (NYTimes)
  • Love in the Time of Ebola: Study Reveals Factors Bolstering Altruism in Face of Risk (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

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

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