Regulatory Reconnaissance (9 July 2013)

Posted 09 July 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • Cytokinetics Shares Slide on Dosing Snafu in ALS Drug Study (Fierce)
  • FDA's Generic-Drug Plan Will Live or Die on Sameness Rule (Law 360)
  • Will Generic Drug Manufacturers Serialize Their Drugs in Time? (RxTrace)
  • Prometheus' Lotronex REMS Could Lose its Sticker Verification Requirement (Pink Sheet) (BioCentury)
  • GSK Announces US Submission for Dabrafenib/Trametinib Combination in Metastatic Melanoma (GSK) (Pharma Times)
  • Fresenius Gets 2nd Warning Letter in 18 Months (Fierce)
  • Senators Push FDA for Stronger Sunscreen Standards (Roll Call)
  • Human Factors: Identifying the Root Causes of Use Errors (MDDI)
  • Pallone, Guthrie Nudge FDA on NDI Guidance (Natural Products Insider)

In Focus: International

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  • Cytokinetics shares slide on dosing snafu in ALS drug study (Fierce)
  • FDA's Generic-Drug Plan Will Live Or Die On Sameness Rule (Law 360)
  • GSK announces US submission for dabrafenib/trametinib combination in metastatic melanoma (GSK) (Pharma Times)
  • Will Generic Drug Manufacturers Serialize Their Drugs In Time? (RxTrace)
  • Omthera Pharmaceuticals Announces NDA Submission for Epanova for the Treatment of Patients with Very High Triglycerides (Omthera)
  • Prometheus' Lotronex REMS Could Lose Its Sticker Verification Requirement (Pink Sheet) (BioCentury)
  • Fresenius gets 2nd warning letter in 18 months (Fierce)
  • Senators Push FDA for Stronger Sunscreen Standards (Roll Call)
  • All the Guidance Documents CDER has Published this Year (FDA)
  • Recent €23 Million Biotech IPO Relied Heavily On Questionable Research (Forbes) (Fierce)
  • Cardio3 says questions over heart drug research are unfounded (Reuters)
  • The Name Game: Will Innovators' Latest Battlefront Kill Biosimilars? (RPM Report)
  • FDA Approves ANDA for Alvogen Pin Brook's Donepezil Hydrochloride (#202114) (FDA)
  • A Preemption Comeback? Merck Wins An Important Ruling (Pharmalot)
  • Massachusetts Legislators to Remedy Weak Oversight At Compounding Pharmacies (Boston Herald)
  • Stronger Drug and Vaccine Safety Systems Overseas, Safer Products at Home: Highlights from the World Health Assembly (FDA)
  • FDA issues fentanyl patch disposal guidelines (DSN)
  • US Pharmas Must Do More on Excipient Quality says expert (In-Pharma Technologist)
  • With drugs in short supply, Missouri tries to bring back the gas chamber (Gawker)
  • A New Obesity Drug Faces The Weight Of History (Forbes)
  • Impax appoints former FDA adviser to board (DSN)
  • US District Court issues final judgment in favor of Mylan in Brovana patent dispute (Pharma Letter)
  • Novartis' secukinumab meets psoriasis endpoints (BioCentury)
Pharmaceuticals: General
  • Paying for New Drugs for New Bugs: Regulation is Only One Side of the Coin (RPM Report)
  • US faces 'new normal' of slower research pace under sequester (SCRIP)
  • HRSA's Secret Letter about Amgen's 340B Neulasta Distribution Strategy (Drug Channels)
Medical Devices
  • Human Factors: Identifying the Root Causes of Use Errors (MDDI)
  • Roche submits filing to FDA for cervical cancer primary screening indication for cobas HPV Test (Roche)
  • FDA clears Singapore company's Bluetooth ECG (MobiHealthNews) (Fierce)
  • Mobile-enabled stethoscope add-on CardioSleeve gets FDA clearance (Mobihealthnews)
  • FDA Clears New Version of Tyrx's Infection-Fighting Pacemaker Sleeve (Xconomy)
  • Medtech Agreement Could Be Relatively Easy Win in EU-US Free Trade Talks (Medtech Insider)
  • OIRA's Markup of FDA's Laser Products Rule (FDA)
  • Is Medtronic's Infuse vulnerable to new lawsuits? (Fierce)
Assorted And Government
  • Pallone, Guthrie Nudge FDA on NDI Guidance (Natural Products Insider)
  • PhRMA joins National Minority Quality Forum initiative to boost trial diversity (Pharma Times)
  • FDA: Delay of Online and Social Media Guidance Creates Confusion (Policy and Medicine)
  • Medical Safety Innovation Gets a Boost from Systematic Analysis (ICT)
  • Internet Pharmacies: Federal Agencies and States Face Challenges Combating Rogue Sites, Particularly Those Abroad (GAO)
  • President's Emergency Plan For Aids Relief: Millions Being Treated, but Better Information Management Needed to Further Improve and Expand Treatment (GAO)
  • Critics of trade talks warn of reckless deregulation (The Hill)
  • Pallone to Introduce Bill to Prevent Medicare Prescription Drug Abuse and Fraud (House)
  • Restless Legs Syndrome (RLS) -- The Patients' Perspective (Forbes)
  • House to pass deregulation bill backed by biotechnology companies (The Hill)
  • Dem bill will aim to stop Medicare drug abuse (The Hill)
  • New OIG Self-Disclosure Form Online Follows Updated Protocol (MediRegs)
Upcoming Meetings And Events
  • 10 July 2013: Meeting of the Drug Safety and Risk Management Advisory Committee Meeting Announcement (FDA)
  • 12 July 2013: Public Meeting: Implementation of Drug Supply Chain Provisions of Title VII of FDASIA (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • EU Court throws out Commission "no" to orphan drug (Pharma Times)
  • Danes want chemicals out of medical devices (EurActiv)
  • New UK DNA Mapping Project Targets Cancer, Rare Diseases And Infectious Diseases (Pharma Times) (Eye for Pharma) (PMLive)
  • Eli Lilly and and Boehringer Ingelheim Announce Regulatory Submission for New Insulin Glargine Biosimilar Product (Eli Lilly) (Pharma Letter) (BioCentury)
  • Pharma views sought on UK regulation (Pharmafile)
  • EU Report on Advanced Therapy Medicinal Products (EuroParl)
  • SMC blocks everolimus for advanced breast cancer (PJO)
  • Novartis 'extremely disappointed' with NICE no for Afinitor (SCRIP)


  • India Clinical Trial Policies Are Aligned With Industry's Goals - MOH Official (PharmAsia)
  • MHRA Suspends Manufacture at Wockhardt's Waluj Facility (In-Pharma Technologist) (Fierce)
  • Seven Nations Join Forces To Keep Eye On Exploding Generics Market (PharmAsia)

Other International

  • How global regulations are written (TIE)
  • GE Issues Recall of Nuclear Medicine Imaging Systems in Australia (TGA)

General Regulatory And Interesting Articles

  • Predictive Analytics and How to Decide Who Should Receive Organ Transplants (IEEE)
  • Tissue Engineering: How to Build a Heart (Scientific American)
  • Ethical quandary about vaccinations sparked by tension between parental rights and protecting public health (EurekAlert)

Regulatory Reconnaissance #103  - 9 July 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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