Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Weekend Edition (21-22 September 2013)

Regulatory Reconnaissance: Weekend Edition (21-22 September 2013)

Posted 20 September 2013 | By Alexander Gaffney, RAC

Welcome to a special weekend edition of Regulatory Reconnaissance, Focus' regulatory news and intelligence briefing.

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US: Pharmaceuticals/Biotechnology

  • Use Only as Directed: Should Tylenol be on the Market as an OTC Product? (ProPublica) (Data)
  • The Voice of the Patient: A Series of Reports from FDA's Patient-Focused Drug Development Initiative (FDA)
  • Legislation Introduced: To Promote The Development Of Meaningful Treatments For Patients (Congress)
  • Amgen Statement on GPhA Citizen Petition on Naming for Biologics (Amgen)
  • Public Workshop on Clinical Trial Design for Intravenous Fat Emulsion (FDA) (FDA)
  • Meetings: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology (FDA)
  • Meetings: Complex Issues in Developing Drug and Biological Products for Rare Diseases (FDA)
  • Approaches to Dispute Resolution with CDER/CBER and the Ombudsmen's Role (FDA) (FDA)
  • How is a drug's name reviewed by FDA? (FDA)
  • More bad news for Ranbaxy: Competitor plans anti-acne drug copy in U.S. (MedCity News)
  • Antibiotic Development and Market Failure: No Quick Fix (Brookings)
  • Thoughts on Sarepta's Future Following Drisapersen's Failure (The Street)
  • Results from Phase III Pooled EINSTEIN Studies Reaffirm Bayer's Xarelto® as an Effective Single-Drug Solution for Venous Thromboembolism (Bayer)

US: Medical Devices

  • FDA Releases Guidance on the Global UDI Database (FDA) (Federal Register)
  • FDA Rleases new CDRH Learn Course on UDI (FDA)
  • AdvaMed Statement on Final Unique Device Identification Rule (AdvaMed)
  • SEC sues Imaging Diagnostic Systems and top execs amid failed FDA bids and IRS issues (Mass Device)
  • Announcement of Requirements and Registration for "System for Locating People Using Electricity Dependent Medical Equipment During Public Health Emergencies Ideation Challenge" (DHHS)

US: Assorted And Government

  • FDA to Hold Meeting on Foreign Supplier Verification Program (FDA)
  • FDA Again Cites Park Doctrine authority in Warning Letter (FDA)
  • Maryland County Looks to Incite a Life Science Alley Next to FDA HQ (Washington Post)
  • House GOP Votes To Fund Government, Kill Obamacare… and Raises Prospect of Government Shutdown (NPR)

Upcoming Meetings And Events

  • 18-19 September 2013: The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes (FDA)
  • 19 September 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19-20 September 2013: Pediatric Advisory Committee Meeting  (FDA) (FDA)
  • 19-20 September 2013: Meeting on Proposed Foreign Supplier Verification Programs (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: ENVI Meeting on Medical Device Proposals (ENVI)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • EU body endorses 11 new drugs from Glaxo, Roche, J&J and others (Fierce) (Roche)
  • ENVI vote a "rushed-through political compromise", says EU medtech industry (Clinica)
  • European consumer org to support EMA in court cases (AllTrials)
  • IQWiG Pans Gilead's Stribild For HIV On Missing Data, Safety Concerns (Pink Sheet)
  • NICE and NHS England prepare medicines optimisation guidance (RPS)


  • India seeks greater market access for pharmaceuticals in Russia (India Times)

Other International

  • J&J vaginal mesh class-action suit grows in Australia (Fierce)

Regulatory Reconnaissance #160 - 21-22 September 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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