Regulatory Focus™ > News Articles > Regulatory Recon: FDA Under Fire for Perceived Lack of AdComm Transparency (9 December 2014)

Regulatory Recon: FDA Under Fire for Perceived Lack of AdComm Transparency (9 December 2014)

Posted 09 December 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Under Fire for Perceived Lack of AdComm Transparency (9 December 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

In Focus: International

  • Number of EU Medical Device Approvals Plunges (Clinica-$)
  • AZ's constipation drug Moventig cleared in EU (PMLive) (PharmaTimes) (Reuters) (Press)
  • Eager-to-please Indian manufacturers creating GMP chaos says expert (In-Pharma)
  • Overview of China’s Medical Device Industry (China Briefing)
  • Health Canada fails to properly regulate drug ads: 10-year study (Vancouver Sun)

US: Pharmaceuticals and Biotechnology

  • FDA Advisory Committee to Review Sandoz Biosimilar (Tarius) (BioCentury)
  • FDA Advisory Committee to Review Astellas’ Isavuconazole for Invasive Aspergillosis and Mucormycosis (Tarius)
  • Third Circuit Kicks OPANA ER Therapeutic Equivalence Rating Lanham Act Case Back to District Court (FDA Law Blog)
  • US Legislator: Keep patient safety paramount with biosimilars (The Hill)
  • FDA Advisory Committee to Review Ferring’s NOCDURNA (Tarius) (FDA)
  • Court rules Hospira can launch generic Cubicin in 2016 (Reuters) (Bloomberg)
  • Texas Looks to Introduce 'Right-to-Try' Measure (ValleyVoice)
  • Arkansas Also Introduces 'Right-to-Try' Legislation (10th Amendment Center)
  • Sarepta hit with securities class action over Eteplirsen (Legal Newsline)
  • PPMD Calls for Greater Transparency and Accountability of FDA Patient Engagement Efforts (Press)
  • NanoString Technologies Updates Prosigna FDA Labeling to Provide Greater Insight into Probability of Breast Cancer Recurrence Between Year 5 and 10 After Diagnosis (Press)

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

  • Aprecia Pharmaceuticals Receives FDA Acceptance for Filing for First Product Using Advanced ZipDose Technology (Press)
  • Lilly and Incyte's oral arthritis drug aces its first Phase III test  (Fierce) (Press)
  • Anticoagulant Effect of Eliquis (apixaban) Reversed by Two Separate 4-Factor Prothrombin Complex Concentrates in Healthy Subjects (Press)
  • Pradaxa antidote effective in key patient groups (PMLive) (Press)
  • Phase 3 Data for Brivaracetam in Partial-Onset Seizures Announced (MPR)
  • Results from Phase IIIb Study of Celgene's POMALYST/IMNOVID (pomalidomide) Plus Low-Dose dexamethasone in Patients with Relapsed and Refractory Multiple Myeloma Presented at ASH (Press)
  • Bluebird 4 For 4 As Gene Therapy Helps More Blood Disease Patients (Xconomy) (Fierce) (WSJ-$) (The Street)
  • Insys Therapeutics Receives FDA Orphan Drug Designation for Liposome Entrapped Paclitaxel as a Potential Treatment for Gastric Cancer (Press)
  • "Technical Dosing Issue" Sidelines Jazz, Concert Pharma Study (Press)

US: Pharmaceuticals and Biotechnology: General

  • BARDA Finds Ways to Help Boost Vaccine Production (Roll Call)
  • How prescription drug abusers are cheating the system by shopping across state lines (WonkBlog)
  • Patients Prescribed Narcotic Painkillers Use More of Them for Longer, Study Finds (NYTimes)

US: Medical Devices

  • FDA Medical Device Advisers’ Financial Ties Not Disclosed (WSJ-$) (WSJ)
  • Edwards CEO hopes FDA to accelerate approvals of medical devices (Reuters)
  • Stryker pleads guilty to selling unapproved devices, to pay $80 million (Reuters) (MassDevice) (Fierce) (Gray Sheet-$) (Modern Healthcare) (FDA)
  • Companies that Fought FDA and Won in 2014 (MDDI)
  • Alere Initiates Voluntary URGENT CORRECTION for Use of Alere INRatio® and INRatio®2 PT/INR Monitor System (FDA)
  • CenterVue EIDON Receives 510(k) FDA Clearance (Press)
  • U.S. Food and Drug Administration Grants CLIA Waiver for Alere Determine HIV-1/2 Ag/Ab Combo Test (Press)
  • Phase One Medical Receives 510(k) Clearance for Symetrex Long Term Hemodialysis Catheter (Press)
  • November 2014 510(k) Clearances (FDA)

US: Dietary Supplements

  • NOI urges FDA to end attempts to regulate dietary supplements as food additives (NI-USA)

US: Assorted And Government

  • FDA Program Alignment For Boosting Specialization Also Stretches Funding (Tan Sheet-$)
  • Passengers Headed to FDA AdComm Meeting Killed in Plane Crash (Washington Post)
  • FDA's Cost Analyses now Including "Lost Pleasure" as a Dicount (Daily News)
  • Former FDA Chief of Staff Joins Boies, Schiller & Flexner (Press)

Upcoming Meetings

Ebola Outbreak

  • How Ebola Drug Trials Today Could Shape Future Drug Development (Xconomy)
  • Ebola Solidifies Some Lawmakers’ Commitment To Biomedical Research Spending (Kaiser)


  • Number of EU Medical Device Approvals Plunges (Clinica-$)
  • AZ's constipation drug Moventig cleared in EU (PMLive) (PharmaTimes) (Reuters) (Press)
  • Quick access to new drug schemes lack transparency (OnMedica)
  • EMA's Workshop With Patient Groups on Benefit-Risk Communication (EMA)
  • NICE changes tack with 'yes' for Janssen's Stelara (PharmaTimes) (SCRIP-$) (PMLive)
  • Roche, Novartis continue fight against Italian fine despite court setback (SCRIP-$)
  • Germany interrupts Europe's Selincro love-in with negative IQWiG outcome (SCRIP-$)
  • SMC OKs five new drugs for routine use in Scotland (PharmaTimes) (PMLive)
  • Drug Maker Feuds With Trade Group Over Marketing Code Oversight (Pharmalot)
  • HTA as a health policy tool in the Council’s conclusions on innovation for the benefit of the patient (EUnetHTA)


  • Eager-to-please Indian manufacturers creating GMP chaos says expert (In-Pharma)
  • Maha FDA suspends officers on grounds of professional misconduct (PharmaBiz)
  • India’s Parliament Questions Ministers On Pharmaceuticals & Medical Devices (Two-Four Insight)
  • India's Cadila launches first cheaper copy of world's top-selling drug (Reuters) (PharmaTimes)
  • Clients desert GVK Bio after goof-up over clinical trial (India Times)


  • Drug Registration and Market Entry Timelines and Drug Pricing in China (Pacific Bridge)
  • Overview of China’s Medical Device Industry (China Briefing)


  • Health Canada fails to properly regulate drug ads: 10-year study (Vancouver Sun)

Clinical Trials

  • 58 requests for patient trial data through new industry platform (SCRIP-$)
  • Pulling Back the Curtain on Clinical Trials Data (FasterCures)
  • What Does Risk-based Monitoring Mean for QA Auditing? (Polaris)

General Regulatory And Interesting Articles

  • Alzheimer’s-in-a-Dish: New Tool for Drug Discovery (NIH)
  • Antibiotics May Not Raise Asthma Risk (NYTimes)
  • Bayer and DNDi Sign First Agreement to Develop an Innovative Oral Treatment for Human River Blindness (DNDi)

Regulatory Reconnaissance #455 – 9 December 2014

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 @AlecGaffney 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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