Regulatory Reconnaissance (17 September 2013)

Posted 17 September 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your news editor is at a conference again today, but will be back to full news coverage on Wednesday.

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In Focus: US

In Focus: International

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  • Mylan hit with Warning Letter over Agila Site (SCRIP) (In-Pharma)
  • J&J, Gilead hepatitis C drugs face FDA review panels in October (SCRIP) (BioCentury) (FDA)
  • CDC Issues Landmark Report on Antibacterial Resistance (TIE) (Scientific American) (NBC) (Reuters) (NYTimes) (WaPo) (Pink Sheet) (SCRIP)
  • How a tough manufacturing process for Advair might help GSK (Health Business Blog)
  • Ranbaxy's Ongoing Issues With FDA Continue Novartis Windfall With Diovan (Pink Sheet) (In-Pharma) (Fierce) (CBS) (Reuters) (Fierce) (FDA)
  • Abuse-Deterrent Generics, Follow-On Issues Among Fiscal 2014 FDA Reg Science Research Priorities (IHP)
  • US import alert on Ranbaxy; Mohali unit part of consent decree (India Times)
  • Sarin Antidote Is Hit With Supply Problems in U.S. (WSJ) (WSJ) (Pharmalot)
  • Baxter Wins Bid To Compel FDA Testimony In Plasma MDL (Law 360)
  • Sticking Points in Compounding Talks Reflect Long-Held FDA Frustrations (FDA News)
  • GPhA, BIO Join In Outlining Problems With House Compounding Bill (Pink Sheet) (IHP)
  • Boehringer Ingelheim's investigational volasertib receives FDA Breakthrough Therapy designation (BI)
  • AHRQ Seeks Information on Medication Therapy Management (AHRQ)
  • FDA approves Teva's generic of Roche blockbuster Xeloda (Fierce) (MedPage Today) (FDA)
  • FTC Head Vows Continued Vigilance Against 'Pay-For-Delay' (Law 360)
  • Kythera's drug successfully reduces double chin in studies (Reuters) (SCRIP)
  • Repros Androxal Meets Main Goals In Second Pivotal Study (RTT)
  • Warner Chilcott Sued Over Loestrin Pay-For-Delay Scheme (Law 360)
  • Pillow Talk? Aveo Execs, Stock Prices And Conflicts Of Interest (Pharmalot)
  • Lupin gets USFDA nod for insomnia drug (India Times)
  • GSK/Genmab win FDA's 'breakthrough' status for Arzerra in CLL (SCRIP)
  • FDA: Advances in Saving Lives with Blood (FDA)
  • USFDA approves DRL's Azacitidine for injection (India Times) (Dr. Reddy's)
  • Invalidity Due to Prior Public Use in ANDA Cases (Patent Docs)
Pharmaceuticals/Biotechnology: General
  • Opioid Prescriptions And Addictions Are On The Rise In The U.S. (Forbes)
Medical Devices
  • Encrypted heartbeat could secure implanted devices (Fierce) (MIT Tech Review) (MedCity News)
  • HeartSine Technologies, Ltd. Issues Global Correction of Samaritan® 300/300P PAD (FDA)
  • Quidel scores FDA nods for Life Tech-powered tests (Fierce) (Quidel)
  • Vital Access Corp Announces FDA Clearance Of VWING™ Vascular Needle Guide (VAC)
Assorted And Government
  • Do TV drug ads tell the whole truth? (EurekAlert)
  • FTC Native Advertising Workshop on December 4, 2013 Will Explore the Blurring of Digital Ads With Digital Content (FTC)
  • Massachusetts Legislature: Bi-Annual Hearing on Restricting Physician Interactions with Industry and Promoting Academic Detailing (Policy and Medicine)
  • HHS Invites Suggestions for Streamlining Regulations (HIWW)
  • HHS Draft Strategic Plan Outlines Department Goals (HIWW)
  • Industry Group Asks FDA to Clarify Position Regarding Manufacturer Dissemination of New Use Information (CHC)
  • CFSAN Priorities for 2013-2014 Include FSMA, Food Labeling, NDIs, Energy Drinks, and Cosmetic Safety (FDA Law Blog)
  • Codex Alimentarius Commission: Meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses (FSIS)
  • Conservatives: Obama will blink on government shutdown (The Hill)
  • Initial Focus of Research in Brain Project Is Chosen (NYTimes) (SCRIP)
Upcoming Meetings And Events
  • 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 18 September 2013: ENVI Meeting on Medical Device Framework (ENVI)
  • 19 September 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19-20 September 2013: Pediatric Advisory Committee Meeting  (FDA) (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • EMA names heads of new divisions (BioCentury) (EMA) (Pharma Times) (SCRIP) (In-Pharma)
  • UK's MHRA reveals advertising lapses (PMLive)
  • Where are the compromise amendments for 18 Sept ENVI vote on medical devices? (Clinica)
  • Draft reflection paper on the data requirements for intravenous iron-based nano-colloidal products developed with reference to an innovator medicinal product (EMA)
  • Sanofi wins EU approval for second MS treatment (Reuters) (Pharma Times) (Genzyme)
  • UK government 'must push for clinical trial transparency' (PMLive) (Pharma Times) (Guardian)
  • UK docs warned of haemophilia risk with Sanofi's clopidogrel (Pharma Times)
  • Committee on Herbal Medicinal Products publishes its meeting agenda for the first time (EMA)
  • New EU animal tissue regulations in effect for some medical devices (Mass Device)
  • JenaValve Gets New CE Mark for Aortic Regurgitation (MedGadget)
  • TAVI: JenaValve lands expanded CE Mark for heart valve (Mass Device)


  • PhRMA, RDPAC In Joint Effort To Deal With China Corruption Problem (PharmAsia) (FT)
  • Indian Health ministry to amend rules for post-approval changes of vaccines, biological products (PharmaBiz)
  • China probing device pricing, but what does the action mean for medtech firms? (MDDI)
  • Ranbaxy Laboratories promises to address issues over US ban (India Times)
  • Better news for tolvaptan as Japan clears use in cirrhosis (SCRIP)
  • GSK Files For Approval Of First New Generation Drug Lamictal For Epilepsy In Japan (PharmAsia)

Other International

  • Digital registration in the works for Costa Rican medical device market (Mass Device)

General Regulatory And Interesting Articles

  • Science vs. Trade Secrets: Can Pharma Tell the Difference? (Hooked)
  • Why personalised medicine is bad for us all (NewScientist)

Regulatory Reconnaissance #156 - 17 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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