Regulatory Focus™ > News Articles > Regulatory Reconnaissance (28 February 2013)

Regulatory Reconnaissance (28 February 2013)

Posted 28 February 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance. Happy rare disease awareness day! It's also the last day before the start of budget sequestration for FDA barring any last-second deals in congress, which seems extremely unlikely.

In the US, an FDA Advisory Committee has given its stamp of approval to a four-strain flu vaccine, Vertex's breakthrough product is slated to speed through clinical trials in half the usual time, Amgen loses an important case before the Supreme Court, and Hospira is in the midst of another inspection.

Abroad, the UK's new patent rules could have huge effects on clinical trials and regulatory, ABPI is moving toward data transparency, a Canadian doctors group says industry is abusing social media to get around DTC advertising bans, and Greece's drug shortages have reached a state of crisis.

Five in Focus:

  1. FDA Panel Signs off on Use of Quadrivalent Vaccine (WSJ)
  2. "Breakthrough" Trials of Vertex Drug Will be Completed in Half the Time as Standard Trials (The Pink Sheet Daily) ($)
  3. Devicemakers: Excise tax, budget battle could cripple industry (Fierce Medical Devices)
  4. ABPI to appoint trial transparency monitor (BioCentury) (Pharma Times) (Pharmafile)
  5. Big Pharma using social media to bypass prohibition on direct-to-consumer ads, Canadian doctors' group says (The Vancouver Sun)



  • As if the sequester weren't enough, the government runs out of money on 27 March 2013 (Washington Post)
  • If Furloughs do Happen, What's the Process? (Washington Post)


  • FDA Panel Signs off on Use of Quadrivalent Vaccine (WSJ)
  • Amgen loses Supreme Court ruling in shareholder suit, can be sued over health risks (Fierce Pharma)
  • Fresenius, B. Braun IV Fluids Tied to More Deaths, Study Finds (Bloomberg)
  • Drug study recruiting at U of M questioned (Star Tribune)
  • "Breakthrough" Trials of Vertex Drug Will be Completed in Half the Time as Standard Trials (The Pink Sheet Daily) ($)
  • Hospira Recalls Lots of Five Injections as FDA Re-Inspection Continues (Outsourcing Pharma) (Fierce Pharma)
  • Allergan settles Botox case of boy on ventilator (Fierce Pharma)
  • National drug shortage spreads to local EMS, fire rescue departments (WPTV)
  • FDA Adds GSK's Advair to List of Products/Companies That Have Compared Pediatric Studies Under PREA (FDA)
  • Speeding Therapeutics towards First-in-Human Trials for Nervous System Disorders (IOM Workshop)
  • New York Moves Hydrocodone Drugs to Schedule II (Press) (Times Union)
  • BTG International Seeks 1,024-Day Patent Term Extension for Zytiga (FDA)
  • Fibrocell Technologies' Seeks Five-Year Patent Term Extension for Laviv (FDA)
  • 16th Annual Conference on Vaccine Research (FDA)
  • Public Workshop: Application in Advances in Nucleic Acid and Protein Based Detection (FDA)
  • Sentinel to Study Health Outcomes, Associations Between Certain Biologics Products and Health/Diseases (Sentinel Initiative) (Flu Vaccines) (2) (Prevnar) (Immunoglobulin)
  • Zogenix Expects FDA to Blow Past PDUFA Date for its Zohydro ER Hydrocodone-Only Drug (Bloomberg) (The Pink Sheet Daily) ($)
  • BIO, PhRMA Blast FDA Draft Guidance on E-Subs for Trial Site Data (Outsourcing Pharma)

Medical Devices

  • J&J Seeks to Avoid Punitives After Losing Mesh Verdict (Bloomberg)
  • FDA Sends Recertification of Mammography Quality Standards to OMB for Review (FDA)
  • Devicemakers: Excise tax, budget battle could cripple industry (Fierce Medical Devices)
  • FDA approves Insulet's next-gen OmniPod insulin device (Fierce Medical Devices)
  • PCORI Convenes Workgroups to Refine Targeted Funding Announcements (PCORI)
  • The Loophole That Keeps Precarious Medical Devices in Use (The Atlantic)
  • Will mHealth certification process, review boards weed out the weak apps? (Med City News)
  • Just Posted: Meeting Materials of the Neurological Devices Panel (22 February 2013) (FDA)
  • Just Posted: Meeting Materials from CDER's 11 February Webinar on GDUFA and Drug Master Files (FDA)
  • Just Posted: Presentation Materials from Workshop on Clinical Development Programs for Peripheral Neuropathy Products (FDA)


  • Under-Reporting of Adverse Events for Supplements to Lead to FDA Scrutiny, Says Fabricant (The Pink Sheet Daily) ($)
  • Enforcement Report - Week of February 27, 2013 (FDA)
  • How do you Recall a Product Without any Manufacturing Lot Codes? (FDA)
  • CDC bioterror labs cited for security flaws in audits (USA Today)
  • Request for Human Embryonic Stem Cell Line To Be Approved for Use in NIH Funded Research (NIH)
  • OMB Proposes Guidance to Simplify Federal Grantmaking Process (RegBlog)


  • The European Commission Accidentally Left Out A Device Labeling Standard When Updating a List of Harmonized Standards, it Says (Eisner Safety)
  • Parliament wants tougher legislation on medical devices (EurActiv)
  • UK patent change will ease drug comparison trials (Nature)
  • France's ANSM is Warning the Public About the Stroke Risk Associated With Another Contraceptive Patch (ANSM)
  • ABPI to appoint trial transparency monitor (BioCentury) (Pharma Times) (Pharmafile)
  • Big Pharma using social media to bypass prohibition on direct-to-consumer ads, Canadian doctors' group says (The Vancouver Sun)
  • Panic in Greek pharmacies as hundreds of medicines run short (The Guardian)
  • New Indian compulsory licences policy raises monopoly concerns (Economic Times)
  • [EPHA Statement] General Data Protection Regulation & Implications for Health Research (EPHA)
  • European Medicines Agency revises three guidance documents to include orphan-related information (EMA)
  • New Science Body to Advise European Commission President (Science Magazine)
  • Questions and answers on the shortage of Vistide (EMA)
  • UK nod for Shire's ADHD drug Elvanse (Pharma Times)


  • Rare disease day celebrated by EMA, PhRMA, others (PhRMA) (EMA)
  • UCB warns of data 'voyeurism' (Pharmafile)
  • What One Novartis Researcher Would Do With Google Glass (Forbes)
  • Medicines Patent Pool Has Another Big Pharma Deal (Pharmalot) (Reuters)
  • No benefit in mechanical removal of clots (UPI)
  • Strict Conflict of interest Policies at Academic Medical Centers Lead to Prescribing Older Generic Drugs (Policy and Medicine)

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.

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