Regulatory Reconnaissance (26-27 October 2013)

Posted 25 October 2013 | By Alexander Gaffney, RAC 

Welcome to a special weekend edition of Regulatory Reconnaissance, Focus' regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know:

US: Pharmaceuticals/Biotechnology

  • FDA approves extended-release, single-entity hydrocodone product Zohydro (FDA) (Reuters) (AP) (Fierce) (MedPage Today)
  • Kaiser v. Pfizer and the Question of Who Pays When Fraudulent Pharmaceutical Promotion Has Its Intended Effect (Harvard)
  • APhA, NACDS, NCPA join biosimilar naming debate (DSN)
  • Wockhardt profit dives as faces U.S., UK regulator demands (Reuters)
  • Group: FDA Move to Restrict Hydrocodone Products Could Harm Patients (NCPA)
  • NPS Pharmaceuticals Seeks Approval for Hypoparathyroidism Drug (Pharma Manufacturing) (Pharma Letter-$)
  • Watson's Silodosin Petition Denied by FDA (FDA Lawyers Blog)

US: Medical Devices

  • FDA approves Abbott's MitraClip heart device (Mass Device) (Fierce) (MedCity News) (Forbes) (Reuters) (Abbott)
  • GE Healthcare Obtains FDA Approval of Vizamyl (Flutemetamol F18 Injection) for Detection of Beta Amyloid (Press) (FDA) (MedPage Today)
  • Analysts: FDA's Approval of Abbott's Mitral Regurgitation Device is Surprising (MDDI)
  • Cochlear's hearing implant lands a date with the FDA (Mass Device)
  • FDA assigns Class I status to GE ventilator/anesthesia machine recalls (Fierce)

US: Dietary Supplements

  • Are bael and its aegeline content set for intense analytical & safety scrutiny? (Nutra Ingredients)

US: Assorted And Government

  • Public Citizen goes on a witch hunt at the FDA (Fierce)

Upcoming Meetings And Events

  • 24-25 October 2013: Antiviral Drugs Advisory Commitee Meeting (FDA) (Day 2)
  • 31 October 2013: Data Harmonization for Patient-Centered Clinical Research (IOM/PCORI)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • CHMP oks four label changes, but turns down Xgeva extension (SCRIP-$)
  • Actelion's orphan drug Opsumit recommended for European approval (SCRIP-$) (Reuters)
  • UCB says gets EU clearance for Cimzia in psoriatic arthritis (Reuters)
  • Synflorix receives positive opinion from the CHMP in Europe for additional pneumonia indication (Press)
  • ViiV Healthcare announces European regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV (Press)

Other International

  • ICH plan to reduce rat carcinogenicity studies moves into new phase (SCRIP-$)

Regulatory Reconnaissance #188 - 26-27 October 2013

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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