Regulatory Focus™ > News Articles > Regulatory Reconnaissance (17 May 2013)

Regulatory Reconnaissance (17 May 2013)

Posted 17 May 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Is the Hatch-Waxman Act Flawed and Should the Supreme Court Fix It? (Becker's Hospital Review)
  • Endo Claims Teva, Others Infringe Uncrushable Opana IP (Law 360)
  • J&J Will Stop Sales of Metal-on-Metal Hip Replacements (Bloomberg) (NYTimes) (Law 360)
  • FDA's Financial Disclosure Guidance Complicated by Sunshine Law (Policy and Medicine)
  • CDRH Close to Issuing Industry Friendly Process Recommendations (BNA)

In Focus: International

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  • Breakthrough Designations Reach 13 (BIO)
  • QRxPharma's Moxduo gets an Advisory Committee Date Before FDA (FDA)
  • Is the Hatch-Waxman Act Flawed and Should the Supreme Court Fix It? (Becker's Hospital Review)
  • Large Compounders' Reporting Requirements Would Move Closer To Manufacturers' In Senate Bill (The Pink Sheet Daily)
  • GDUFA Self-Reporting Deadline for Facilities is on 31 May 2013 (FDA)
  • Mylan's Autor-de-Force Move into Quality "Differentiation" and Sterile Injectables (RPM Report)
  • FDA Approves APOQUEL® (oclacitinib tablet) to Control Itch and Inflammation in Allergic Dogs (Business Wire)
  •  Pills Tracked From Doctor to Patient to Aid Drug Marketing (NYTimes)
  • Analysis of King County's Proposed Mandatory Drug Take-back Program (Washington Policy Center)
  • FDA Expects 65 Companies to use its Electronic Submission Gateway for Veterinary Products this Year (FDA)
  • FDA Updates Estimated Reporting Burden for 2004 Barcode Rule (FDA)
  • Endo Claims Teva, Others Infringe Uncrushable Opana IP (Law 360)
  • Purdue Puts Generic OxyContin Suits To Rest (Law 360)
  • Sanofi plans to file JAK2 inhibitor after positive phase III (PMLive) (Pharma Times)
  • Promising first Phase III data for Takeda's fasiglifam (SCRIP Intelligence)
  • FDA Approves Zydus Pharmaceuticals' ANDA for Zolmitriptan (#202890) (FDA)
Medical Devices
  • J&J Will Stop Sales of Metal-on-Metal Hip Replacements (Bloomberg) (NYTimes) (Law 360)
  • CDRH Pursuing Several Initiatives Affecting Medical Devices, Official Says (BNA)
  • Standardized Device Labeling Still an Undefined Concept: Stakeholders (FDA News)
  • Symbios Medical Products Issues Nationwide Recall of GOPump and GOBlock Kits (FDA)
  • X-Spine wins FDA clearance for spinal fusion system (Mass Device)
  • Direct Flow Medical Receives IDE Approval for U.S. SALUS Trial of Transcatheter Aortic Heart Valve System (Business Wire)
Assorted and Government
  • "Systemic" Disregard For Basic Dietary Ingredient Rule Troubles FDA (The Pink Sheet Daily)
  • FDA subcommittee to examine regulatory science for neonatal studies (Contemporary Pediatrics)
  • Proposed FDA Guidance on Financial Disclosure and the Physician Payment Sunshine Regulations - Divergent Paths and Duplicated Efforts (Policy and Medicine)
  • States wade into disclosure rules on biosimilars (American Medical News)
  • FDA: No Changes Post-Caronia (FDA Webview)
  • Trade Deal Extension Generates Support From Congress (Pharmalot)
  • FDA Calls for Comments on its Postmarketing Surveillance Burdens (FDA)
  • Psychiatrists unveil the DSM-5 (Reuters)
  • Why is the FDA Looking at Sports Supplements? (Natural Products Insider)
  • Dietary supplement caucus addresses supplements in sports health and fitness (Nutra Ingredients USA)
  • Use of central institutional review boards for multicenter clinical trials in the United States: A review of the literature (National Clinical Trial Network)
  • Congressional Research Service: If IPAB is Blocked, Sebelius can take place of controversial Medicare board (The Hill)
  • Lilly to CMS: Failure to cover Amyvid will chill Alzheimer's R&D (SCRIP Intelligence)
  • HIT Standards Committee; Schedule for the Assessment of HIT Policy Committee Recommendations (DHHS)
  • S.972 - A bill to prohibit the Secretary of Health and Human Services replacing ICD-9 with ICD-10 in implementing the HIPAA code set standards (Congress) 
Upcoming Meetings and Events
  • 14-15 May 2013: E&C Committee to Markup ADUFA/ADGDUFA User Fee Bills (E&C)
  • 14-15 May 2013: E&C Committee to Markup Pharmaceutical Track and Trace Legislation (E&C)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • 17 May 2013: NCATS Meeting (NCATS)
  • 22 May 2013: Markup of Senate Compounding, Track and Trace Legislation (HELP)
  • 21-22 May 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 22 May 2013: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
  • 22 May 2013: CVM's New Animal Drugs for Use in Feeds Workshop (FDA)
  • 23 May 2013: Energy and Commerce Committee Hearting, "Examining Drug Compounding" (E&C)
  • 23 May 2013: Reagan-Udall Foundation Annual Open Public Meeting (RU)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • J&J Faces Criminal Charges In South Korea Over Tylenol Production (Pharmalot) (PharmAsia News) (Fierce Pharma Manufacturing)
  • Another Ranbaxy Mystery: What Happened To Valsartan? (PharmAsia News)
  • 1307 amendments, 1.5-hour EU Parliament session (Clinica)
  • Malaysia Drug Regulators See Harmonization As Long-Term Plus For Domestic Industry (PharmAsia News)
  • PRAC Reviewing Servier's Protelos/Osseor due to Potential Risk of Heart Attacks (EMA)
  • Improved voluntary harmonization procedure delivers significant benefits for multinational clinical trials in Europe (The Pharma Letter)
  • India Institutes New Pricing System For Essential Drugs, Prices to Fall "up to 80%" (Pharma Times) (PharmAsia News) (SCRIP Intelligence) (India Times) (SCRIP Intelligence)
  • China also Considering Price Cuts for Essential Drug List (PharmAsia News)
  • EMA: Benefits of Diane 35 and generics outweigh risks in specific patient group (EMA)
  • Shire's shenanigans continue; guilty of 10 Code breaches (Pharma Times)
  • Request for Feedback on PHARMAC'S Initial Medical Device Activity (PHARMAC)
  • NICE thumbs up for new Astellas bladder drug Betmiga  (Pharma Times) (The Pink Sheet) (SCRIP Intelligence)
  • China arrests dozens, seizes tens of millions of counterfeit drugs (Fierce Pharma Manufacturing)
  • Chinese regulators take steps to ease medical device registration (Mass Device)
  • Japan Health Ministry Orders Probe Of HPV Vaccine Side Effects (PharmAsia News)
  • St. Jude Medical Announces European Approval of 3-D Vessel Reconstruction Technology to Aid Physicians in Stent Placement (Business Wire)
  • Tryton Medical Announces CE Mark and European Launch of Next-Generation Tryton Side Branch SHORT Stent (Business Wire)
  • UK 'animal research' labelling plan may have unintended consequences says Cyprotex (Outsourcing Pharma)
  • Chinese drugmaker taps mPedigree for antimalarial authentication (Securing Industry)
  • Citizens in poor EU states can't afford medicines, health promoters say (EurActiv)

General Regulatory and Interesting Articles

Regulatory Reconnaissance #69 - 17 May 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.

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