Regulatory Focus™ > News Articles > Regulatory Reconnaissance (26 April 2013)

Regulatory Reconnaissance (26 April 2013)

Posted 26 April 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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  • GOP chairman promises drug-tracking law by August (The Hill) (Modern Healthcare)
  • Shire settles with Actavis, Watson Pharma on ADHD drug (Reuters) (Pharma Times) (Law 360)
  • Bristol-Myers gains FDA's 'breakthrough' track in race for hep C drug approval (Fierce Biotech) (MM&M)
  • Abbott Regulatory Professional Testifies in Case About Risks of Humira (Law 360) ($)
  • Actelion Pharmaceuticals' Citizen Petition Calls for Denial of Any Generic Versions of Ventavis (iloprost) (FDA Docket)
  • Hemispherx Misled Investors Over Anti-Fatigue Drug, Suit Says (Law 360) ($)
  • J&J Building Electronic Drug-Tracking System In Anticipation of California's E-Pedigree (The Pink Sheet) ($)
  • Cancer Trials Should Show Minimum 20% Overall Survival Benefit, ASCO Suggests (The Pink Sheet) ($)
  • Pfizer's Ph IV Study on Celcoxib Meets Primary Endpoints (Pfizer)
  • Aurobindo Pharma gets USFDA nod for Cefadroxil oral suspension (India Times)
  • FDA Approves ANDAs for Lupin's Primella and Amneal Pharmaceuticals' Promethazine HCl and Codein Phosphate (FDA)
  • FDA Approves Efficacy Supplement for Janssen's Prezista (FDA)
  • Counterfeit Avastin, A Guilty Plea And A $6M Forfeiture (Pharmalot)
  • NEJM fumarate PML cases 'old news,' Biogen's Scangos insists (SCRIP Intelligence) ($)
  • Securing US Rx drug supply: 25 years of propose & delay (SCRIP Intelligence) ($)
  • U.S. H7N9 vaccine could be ready in the fall (BioCentury)
  • Public Notification: "Zoom-Zooma-Zoom" Contains Hidden Drug Ingredient (FDA)
  • Defense-to-Offense: Biopharma Readies to Protect Government Markets (RPM Report) ($)
  • Celgene submits apremilast NDA, reports earns (BioCentury)
  • Novartis expands cell culture site to bolster biodefense (Fierce Vacciness)
  • Facing Manufacturing Woes, Alexion Strengthens Leadership (The Pink Sheet) ($)
  • Public Notification: "Sex Plus" Contains Hidden Drug Ingredient (FDA)
Medical Devices
  • FDA Grants Emergency Use Authorization for H7N9 Detection Device (FDA)
  • FDA to Discuss "Future Policy on 510(k) Modifications" at Upcoming Meeting (FDA)
  • Medical Devices Subject to Hacking, Putting National Security at Risk, Say Researchers (Slate)
  • Potential for Delivery System Catheter Separation Prompts Cook Medical to Initiate Voluntary Global Recall of Zilver PTX Drug Eluting Stent (FDA) (Cardiovascular Business)
  • More Robots, More Safety/Marketing Concerns (Health News Watchdog)
  • Olympus Medical wins FDA clearance for HD 3D surgical system (Mass Device)
  • NuVasive Hit With Patent Suit Over Bone Screw Device (Law 360) ($)
  • Companies offer to donate prosthetic limbs to injured victims (Boston Herald)
  • Government halts HIV vaccine trial after shot fails to prevent infections (CBS) (Reuters) (NBC) (Bloomberg)
  • Government issues first safety rules for nano-dust (NBC)
  • FDA Contributing to Fight Against Polio (FDA)
  • Clinical Trials Shed Light on Minority Health (FDA)
  • IOM Workshop: Assuring Integrity while Facilitating Innovation in Medical Research: A Workshop (IOM)
  • Warning and NOV Summary - 1st Quarter 2013 (Eye on FDA)
  • Why Finding A TB Test Got Hard (Hint: Shortages) (NPR)
  • Moldy marijuana? Legal markets spark push for health, safety standards (NBC)
  • Harvard Professor Re-Identifies Anonymous Volunteers In DNA Study (Forbes)
Government and Budget
  • Obama taps FTC official as new regulatory czar (The Hill)
  • Health Subcommittee Examines Proposal to Improve the Security of America's Pharmaceutical Supply Chains (Energy and Commerce) (GPhA)
  • 2012 Was the Costliest Year for Regulation Ever (American Action Forum)
Upcoming Meetings and Events
  • 22 April 2013: Public Meeting - International Consortium of Cardiovascular Registries (FDA)
  • 23 April 2013: FDA Webinar: Home Use of Diabetes and Cardiovascular Medical Devices (FDA)
  • 23 April 2013: Margaret Hamburg to Keynote FDLI's Conference (FDLI) (Speech)
  • 23 April 2013: FDA Listening Meeting on Use of Antibiotics in Animals in Olympia, WA (FDA)
  • 25 April 2013: Securing Our Nation's Prescription Drug Supply Chain (Energy and Commerce Committee)
  • 25-26 April 2013: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting (FDA) (Meeting Materials Posted)
  • 25-26 April 2013: Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS) (FDA)
  • 26 April 2013: Senate Appropriations Committee to Markup FDA Bill (Appropriations)
  • 26 April 2013: Does HIPAA Help or Hinder Patient Care and Public Safety? (Energy and Commerce Committee)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA) (FDA)


  • EMA Releases Good Pharmacovigilance Practices (GVP) Module VII (PSUR) (PSUR) (Monitoring) (Abbreviations) (Transmission) (Post-Auth Studies)
  • Boehringer: Move towards trial transparency is "irreversible," Will Publish All Trials Data (PMLive)
  • EMA refuses to back Pfizer's Xeljanz in rheumatoid arthritis (Reuters) (Pfizer) (PMLive) (The Pharma Letter) (BioCentury) (Pharma Times) (Bloomberg)
  • Meeting Minutes of EMA's PRAC (4-7 March 2013) (EMA)
  • Germany increases pensions for thalidomide victims (Reuters)
  • Health Canada takes longer to approve new drugs than European and US counterparts (The Pharma Letter)
  • GSK announces regulatory submission for umeclidinium monotherapy in European Union (GSK)
  • NICE turns town Novartis' blood cancer drug Jakavi (PMLive) (Pharma Times) (SCRIP Intelligence) (The Pharma Letter)
  • Roche's Skin-Cancer Drug Erivedge Wins EU Agency Backing (Bloomberg)
  • Around 20% Of Drug Wholesalers, 15% Retailers Meet New GMP In China (PharmAsia News) ($)
  • Israel Ministry Orders Probe Of Novo Nordisk Drug Tie To Pancreatitis (PharmAsia News) ($)
  • Draft guideline on the compliance of authorised equine influenza vaccines with OIE requirements (EMA)
  • EU member states urged to boost biosimilars market access (The Pharma Letter) ($)
  • UK Health Secretary to strengthen patient privacy on confidential data use (NHS)
  • EU ponders biopiracy law to protect indigeneous people (EurActiv)
  • ABPI: Pharma must sell outcomes, not products (PMLive)
  • ABPI: We are struggling to understand NHS change (Pharma Times)
  • India's Commerce ministry eyes Latin American & African markets to boost exports (PharmaBiz)
  • Should the UK introduce compulsory vaccination? (The Lancet)

General Regulatory and Interesting Articles

  • Doctors Denounce Cancer Drug Prices of $100,000 a Year (NYTimes)
  • H7N9 flu: Complex, difficult, evolving & among most lethal (SCRIP Intelligence) ($)

Regulatory Reconnaissance #54 - 26 April 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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