Regulatory Reconnaissance: Does CDER Need New Leadership? (30 January 2014)

Posted 30 January 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

  • Graft Charges At India State Drug Controller's Office Lead To Multiple Transfers (PharmAsia-$)
  • DCGI asks states to report instantly warnings given to Indian companies by foreign regulatory bodies (PharmaBiz)
  • Chinese health professionals' conduct to be regulated (Pharma Letter-$)
  • Medical Research Council grants £3m for drug safety center investment (Press)

US: Pharmaceuticals/Biotechnology

  • J&J in 'game-changing' data disclosure plan (Pharmafile) (Forbes) (Pink Sheet-$) (Xconomy) (Forbes) (WSJ-$) (Reuters) (Press)
  • Moscicki: time to replenish CDER leadership (BioCentury)
  • Pharmaceutical and Device Healthcare Fraud: Enforcement Perspectives for 2014 (Policy and Medicine)
  • Industry Challenges Hydrocodone Combination Reclassification in Citizen Petition (FDA Law Blog)
  • Whoops, we may have done it again: FDA wrong on naproxen CV risk? (SCRIP-$)
  • Cadila gets USFDA nod to market arthritis drug Etodolac (India Times)
  • Assessing the Clinical Benefits of Lipid-Disorder Drugs (NEJM)
  • Celgene's Abraxane Under Fire in NEJM Letter (The Street)

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

  • Vertex snags another FDA 'breakthrough' status (SCRIP-$) (BioCentury)
  • Novartis races to the FDA with its 'breakthrough' lung cancer drug (Fierce)
  • Salix Announces Acceptance of NDA Filing For Budesonide Foam in Patients with Distal Ulcerative Colitis (Press)

US: Pharmaceuticals and Biotechnology: General

  • NYTimes Slams Use of Compounding Pharmacies in State Executions (NYTimes)
  • AHF to Ask States to Block Gilead's $1,000 per Pill Hepatitis Drug From Medicaid Formularies (Press)
  • Vertex bows out of hepatitis C race to focus on cystic fibrosis (SCRIP-$)

US: Medical Devices

  • Device Innovation Consortium Plans To Finish Patient-Centered Project This Year (Gray Sheet-$)
  • Which Device Firms Had the Most Class I Recall Events in 2013? (MDDI)
  • CDC to Assess new Influenza Diagnostic Testing and Reporting Technologies (CDC)
  • NEJM reviews ChloraPrep study in patient safety controversy (Mass Device)
  • FDA dings Mercy Hospital's device trial review board (Mass Device)
  • Medtronic's stent graft follows Gore's into aortic dissections with FDA approval (Fierce)
  • AtheroMed wins 510(k) clearance for atherectomy catheter (Mass Device)

US: Dietary Supplements

  • FDA Guidances Pose Regulatory Challenges for Functional Foods (Sidley)
  • FDA Leaves Beverage-Labeling Questions Unanswered (Law 360-$)
  • Some supplements might fuel tumors, study finds (NBC)
  • cGMP Certified Isn't Enough (NPI)
  • CRN recommends making FSVP rules apply to all importers of dietary supplements (NI-USA)

US: Assorted And Government

  • What Attorneys Should Know About FDA's MedWatch Data (Law 360-$)
  • Dependable or Dispensable? Using Banner Advertising for Patient Recruitment (CAHG)

Upcoming Meetings And Events

  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 29-30 January 2014: Science Advisory Board to the National Center for Toxicological Research Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • EMA to review Helsinn CINV product (BioCentury)
  • Medical Research Council grants £3m for drug safety center investment (Press)
  • NC3RS awards £1.56 mill for CRACK IT preclinical challenges (Pharma Times)
  • NICE Gives Go Ahead To NeoTract's UroLift Prostate Implant (Press)
  • Experts urge a greater voice for patients in defining "essential" medicines (Pharma Times)


  • Graft Charges At India State Drug Controller's Office Lead To Multiple Transfers (PharmAsia-$)
  • DCGI asks states to report instantly warnings given to Indian companies by foreign regulatory bodies (PharmaBiz)
  • India's top drug regulator says he will do surprise inspections of foreign-owned plants (Fierce)

Japan & China

  • Chinese health professionals' conduct to be regulated (Pharma Letter-$)
  • Japan`s Drug Committee Approves Bristol-Myers Squibb SGLT-2 Inhibitor (PharmAsia-$)

General Regulatory And Interesting Articles

  • Biosimilar monoclonal antibodies development simplified (GaBi)
  • New Concern About Testosterone and Heart Risks (NYTimes) (NBC) (Forbes)

Regulatory Reconnaissance #246 - 30 January 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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

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