Regulatory Reconnaissance: Fresenius Accused of Firing Regulatory Whistleblower (16 January 2013)

Posted 16 January 2014 | By Alexander Gaffney, RAC 

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In Focus: US

In Focus: International

US: Pharmaceuticals/Biotechnology

  • Lawsuit alleges drugmaker Fresenius Kabi retaliated against regulatory whistleblower (Crain's) (Fierce)
  • FDA CRDAC backs Merck's antiplatelet vorapaxar (SCRIP-$) (Pharma Letter-$) (Pink Sheet-$) (Pharmafile) (PMLive) (Pharma Times) (BioCentury) (Press) (Forbes) (Reuters)
  • Amarin says FDA delays decision on Vascepa trial design (BioCentury) (Reuters)
  • FDA "Program" Reviews Are Positive So Far, But Are They Sustainable? (RPM Report-$)
  • Genentech fixes problems that earned US Herceptin plant a Form 483 (BioPharma Reporter)
  • Dismissing Requests of World's Gelatin Makers, FDA Asks USP to Add Tests for Melamine to Monograph (Gold Sheet-$)
  • FDA Grants 37 Breakthrough Designations in 2013 (Press)
  • FDA Scales Back Near-Term Goals For Sentinel Postmarket Data Network (Pink Sheet-$)
  • FDA Seeks Comment on Generic Dexmedetomidine HCl Injection (PRECEDEX) Approval (FDA Law Blog)
  • USP Announces Revision Timeline, Effective Date for Elemental Impurities Limits and Procedures (Pharmtech)
  • OOPD Clarifies Orphan Drug Designation Policies for Scleroderma and Pulmonary Hypertension (FDA Law Blog)
  • After Regulatory Setbacks, OvaScience to focus on baby-making efforts overseas (BioFlash)
  • Affymax Says It Didn't Mislead Investors About Anemia Drug (Law 360-$)

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

  • Iroko's Zorvolex under FDA review for osteoarthritis pain (SCRIP-$)
  • Sarepta Therapeutics Announces Eteplirsen Demonstrates Continued Stability on Walking Test through 120 Weeks in Phase IIb Study in Duchenne Muscular Dystrophy (Press)

US: Medical Devices

  • FDA clampdown on 23andMe is unwarranted without evidence of harm, say researchers (Nature) (QZ)
  • 510(k), Other Key Device Issues Remain In Spotlight For 2014 (IHP-$)
  • Document Control Hot Spots - What Manufacturers Can Do To Avoid Them (Silver Sheet-$)
  • 6 Questions Answered By An FDA Investigator (Silver Sheet-$)
  • Some Wart Removers are Flammable (FDA)
  • Covidien's ventilator recall gets hit with FDA's 'most serious' Class I label (Fierce)
  • Jury Awards Edwards $393M In Medtronic Valve Patent Row (Law 360-$) (Mass Device) (Fierce) (MDDI)
  • Topera Medical's 3rd Generation Cardiac Mapping System Gets FDA OK (MedGadget)
  • OptionELITE Retrievable Vena Cava Filter Receives FDA Clearance for a New Over-The-Wire Delivery Technique (Press)

US: Dietary Supplements

  • NAD refers ad claims made by Coorga Nutraceuticals for its Grey Defense dietary supplements to FTC (DSN)

US: Assorted And Government

  • Update on FDA's FY 14 Appropriation Bill (Strengthen FDA)
  • Data transparency moves increase cyber-attack risks (PharmaTimes)
  • FY14 spending package passes House (Federal Times) (The Hill)
  • FDA Enforcement Report - Week of January 15, 2014 (FDA)
  • (Some) Relief For Research Scientists In Congressional Budget Deal (TPM)

Upcoming Meetings And Events

  • 16 January 2014: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 28 January 2014: Allergenic Products Advisory Committee Meeting (FDA)
  • 28 January 2013: US State of the Union Address (White House)
  • 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)


  • Give EU states greater freedom for early access to meds, report urges (Pharma Times)
  • On-X Life Technologies Reports CE Mark Approval to Sell Its Mechanical Aortic Heart Valve with an Expanded Labeling Claim: a Reduction in the Required Use of Blood Thinners (Press)
  • Op-Ed: Why the GMC should set up a central registry of doctors' competing interests (BMJ) (Pharmafile)


General Regulatory And Interesting Articles

  • How Many Good Drugs are Buried in the Pharma Graveyard (Placebo Lead-In)
  • Experimental gene therapy improves sight in patients going blind (Reuters) (NBC)
  • Smart gels to deliver medicine on demand (Press)
  • Antidepressants during pregnancy may raise risk for lung problems in babies (CBS)
  • The New Cough and Cold Products for Children: Evidence is Optional and Science is Marketing (Science-Based Medicine)

Regulatory Reconnaissance #237 - 16 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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