Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Watchdog Sues FDA Over GERD Drug (1 May 2014)

Regulatory Reconnaissance: Watchdog Sues FDA Over GERD Drug (1 May 2014)

Posted 01 May 2014 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • Citing Fracture Risk, Watchdog Group Sues FDA to Force GERD Drug Warning (MedPage Today) (Law 360-$)
  • Pew Report: Implementing the DQSA's Track and Trace Requirements (Pew)
  • GSK receives approval for Incruse Ellipta (umeclidinium) in the US for the treatment of COPD (GSK) (SCRIP-$) (BioCentury)
  • Pharmalogical Inc. officers indicted in cancer drug fraud, feds say (Newsday)
  • FDA's Bad Ad Program Mostly Silent in 2014 (Pharmaspective)
  • Endo to Pay $830 Million to Settle Transvaginal Mesh Claims (NYTimes) (Law 360-$)
  • FDA clears Intuitive Surgical over warning letter (Mass Device) (NASDAQ)
  • Consumer Advocates: FDA's Action On Vaginal Mesh 'Too Little Too Late' (WBUR)
  • USTR Issues Report (PhRMA) (USTR) (Pink Sheet-$) (PharmAsia-$)

In Focus: International

  • EMA Releases Draft guideline on Insulin Biosimilars (EMA)
  • EMA Draft guideline on non-clinical local tolerance testing of medicinal products (EMA)
  • NICE wants companies to alert it to possible candidates for the early access to medicines scheme (PJO)
  • High fees jeopardize early access scheme (SCRIP-$)
  • Indian Industry Forming Partnership to Refurbish Regulatory Image (India Times)
  • GlaxoSmithKline dispatches sales and marketing team to clean up in China (Fierce)
  • Restraint Advised in Testing for Elemental Impurities (Gold Sheet-$)

US: Pharmaceuticals/Biotechnology

  • Citing Fracture Risk, Watchdog Group Sues FDA to Force GERD Drug Warning (MedPage Today) (Law 360-$)
  • Pew Report: Implementing the DQSA's Track and Trace Requirements (Pew)
  • GSK receives approval for Incruse Ellipta (umeclidinium) in the US for the treatment of COPD (GSK) (SCRIP-$) (BioCentury)
  • Pharmalogical Inc. officers indicted in cancer drug fraud, feds say (Newsday)
  • FDA Launches Vigorous and Extensive Defense of  Decision to Approve Zohydro (FDA)
  • E&C Aide: Dems Skeptical Of Upton Plan To Reform Drug Approval Process (IHP-$)
  • Sanofi's MS team rebuilds its case for the FDA-rejected MS drug Lemtrada (Fierce)
  • FDA's Bad Ad Program Mostly Silent in 2014 (Pharmaspective)
  • Read up on FDA's OTC Reform Meeting (FDA) (FDA)
  • How to Optimize Your eCTD ANDA Submission (FDA)
  • ASCO Personalized Meds Project Aims To Develop Outcomes Data For Off-Label Uses (Pink Sheet-$)
  • Merck Singulair Allergy Switch Must Address Neuropsychiatric Concerns (Tan Sheet-$) (SCRIP-$)
  • OMB Signs off on FDA's Breakthrough Products Review Guidance (FDA)
  • OMB Signs off on FDA's Special Protocol Assessment Guidance (FDA)
  • HDMA Releases New DQSA Compliance Guide (RxTrace)
  • FDA Cracks Down On Autism Quackery (Forbes)
  • Natural OTCs Sprout From Firms' Innovations Within Monograph Limits (Pink Sheet-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Purdue Pharma Files OK for New Painkiller, Competitor to Zohydro (AP) (MM&M) (SCRIP-$) (BioCentury) (Pink Sheet-$)
  • Merrimack heads to the FDA after scoring positive PhIII for pancreatic cancer (Fierce) (Xconomy)
  • FDA calls for more info on The Medicines Company's cangrelor (Pharma Letter-$)
  • US FDA grants priority review for AstraZeneca's olaparib (Pharma Letter-$)
  • SAGE Therapeutics Receives U.S. Orphan Drug Designation for Lead Compound SAGE-547 to Treat Status Epilepticus (Press)
  • Pfizer's ALO-02 Demonstrates Significant Difference In Pain Scores In Chronic Low Back Pain Patients And Lower Abuse Potential Compared To Immediate-Release Oxycodone In Recreational Opioid Users (Press)
  • Biopsy snafu torpedoes PhII prostate cancer data for Nymox (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • Pfizer To Pay $73M To Settle Pay-For-Delay Claims (Law 360-$)
  • HHS' OIG Wants More Oversight of Compounding Pharmacies (OIG)
  • Drug Prices Defy Gravity, Doubling for Dozens of Products (Bloomberg)
  • Gilead says its drug gives hepatitis C patients more cost-effective cure (Market Watch)

US: Medical Devices

  • Endo to Pay $830 Million to Settle Transvaginal Mesh Claims (NYTimes) (Law 360-$)
  • FDA clears Intuitive Surgical over warning letter (Mass Device) (NASDAQ)
  • Consumer Advocates: FDA's Action On Vaginal Mesh 'Too Little Too Late' (WBUR)
  • Device Recall 'SWAT Teams': A Primer (Gray Sheet-$)
  • Video Game Under FDA Review (Scientific Computing)
  • FDA Clears GE's New Discovery IGS 740 Mobile Angiography System (Press)
  • EnteroMedics Presses Towards Approval, Rollout Of Novel Obesity Device (Gray Sheet-$)
  • TRI's ND Infusion Catheter FDA Approved  (MedGadget)
  • InspireMD pulls MGuard Prime EPS stent, suspends U.S. trial (Mass Device)
  • Seeing the world through bionic eyes (Mass Device)

US: Dietary Supplements

  • Bacai Inc. Issues Voluntary Worldwide Recall of LiteFit USA (FDA)

US: Assorted And Government

  • USTR Issues Report (PhRMA) (USTR) (Pink Sheet-$) (PharmAsia-$)
  • US Spurns Eli Lilly's Bid To Prod Canada On Drug Patents (Law 360-$)
  • Challenges of Implementing CDISC SDTM Standards for FDA Submissions (Geeks Talk Clinical)
  • Twitter is rich with adverse drug reaction data, but it's hard to parse (MobiHealthNews)
  • House opens appropriations debate (The Hill)
  • Meet the woman behind a shortage of execution drugs (CBS)

Europe

  • EMA Releases Draft guideline on Insulin Biosimilars (EMA)
  • Draft guideline on non-clinical local tolerance testing of medicinal products (EMA)
  • NICE wants companies to alert it to possible candidates for the early access to medicines scheme (PJO)
  • High fees jeopardize early access scheme (SCRIP-$)
  • Otsuka wins approval for TB drug Deltyba (PMLive) (DD&D) (SCRIP-$) (Pharma Times)
  • Acutus lands European approval for heart-mapping 'Katheter' (Mass Device)

India

  • Indian Industry Forming Partnership to Refurbish Regulatory Image (India Times)

Japan & China

  • GlaxoSmithKline dispatches sales and marketing team to clean up in China (Fierce)
  • Daiichi Sankyo halts nimotuzumab Ph III trial in lung cancer (Pharma Letter-$) (PharmAsia-$)
  • MHLW Demands Changes To Warnings For Sanofi's Benambax (PharmAsia-$)

Other International

  • Restraint Advised in Testing for Elemental Impurities (Gold Sheet-$)
  • ICH Urged to Allow for Bioaccessibility in Metal Impurities Standards (Gold Sheet-$)
  • GMP Implementation Challenges Seen as More Asia-Pacific Regulators Join PIC/S (Gold Sheet-$)
  • Latin American Countries Easing Strict Rules on Product Retesting (Gold Sheet-$)

General Regulatory And Interesting Articles

  • Global biosimilars pipeline expands 40% in 12 months: study (Pharma Times)

Regulatory Reconnaissance #309 - 1 May 2014

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 news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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