Regulatory Focus™ > News Articles > Regulatory Reconnaissance (15 October 2013)

Regulatory Reconnaissance (15 October 2013)

Posted 15 October 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Your editor took yesterday off, so this edition of Regulatory Reconnaissance covers everything I would have posted yesterday as well. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • FDA's Old Guard Fades Away in Enforcement Shakeup (MDDI)
  • US FDA inspectors face "huge backlog" when Shutdown eventually ends (In-Pharma)
  • The Soaring Cost of a Simple Breath: How Regulation Influences the Price of Asthma Medication (NYTimes) (Fierce)
  • Tylenol Killings Remain Unsolved and Unforgotten After 30 Years (WSJ-$)
  • California Gov Vetoes Biosimilar Substitution Bill (Pharmalot) (NYTimes) (Press) (BioCentury) (Pharma Times) (FDA Law Blog)
  • Shutdown Week Two: Could Sponsors Find A More Focused FDA? (Pink Sheet-$)
  • $18.4 Million In User Fees Left In CDRH's Coffers, How Long Will It Last? (Gray Sheet-$)
  • FDA Proposal For Cybersecurity Info In Pre-market Submissions Generates Debate (Gray Sheet-$)
  • Legislator working on legislation to clarify FDA's authority over mobile health apps (Gray Sheet-$) (GovHealthIT)

In Focus: International

  • ENVI Posts Amended Text of IVD Legislation (ENVI) (Clinica-$)
  • UK health regulator withdraws certification of Wockhardt unit (India Times) (DD&D) (Fierce) (Pharmalot)
  • Bayer challenges IPAB's compulsory licence order to Natco Pharma on cancer drug Nexavar (India Times) (Pharmalot)
  • Spaniards sue German firm over thalidomide (AP)
  • Legal recourse against delegated and implementing acts in the medical devices regulation (Medical Devices Legal)
  • EMA encourages companies to submit quality type I variations for 2013 by end of November (EMA)

US: Pharmaceuticals/Biotechnology

  • The Soaring Cost of a Simple Breath: How Regulation Influences the Price of Asthma Medication (NYTimes) (Fierce)
  • Tylenol Killings Remain Unsolved and Unforgotten After 30 Years (WSJ-$)
  • California Gov Vetoes Biosimilar Substitution Bill (Pharmalot) (NYTimes) (Press) (BioCentury) (Pharma Times) (FDA Law Blog)
  • Shutdown Week Two: Could Sponsors Find A More Focused FDA? (Pink Sheet-$)
  • FDA/Industry Interactions Might Get Revised Rules Of Road After Opioid Publicity (Pink Sheet-$)
  • FDA's Drug Labeling Decisions Complicated By Uncertain Target Audience, Limited Authority (Pink Sheet-$)
  • MannKind Resubmits New Drug Application to U.S. FDA for AFREZZA for the Treatment of Adults with Diabetes (Pink Sheet-$) (BioCentury) (Press) (Pharma Times) (Pharma Letter-$) (SCRIP-$) (PMLive)
  • Why The FDA Probably Won't Approve An Expanded Indication For Amarin's Vascepa (Forbes)
  • The Regulation of Prescription Drug Competition and Market Responses: Patterns in Prices and Sales Following Loss of Exclusivity (Brookings)
  • Maine Law Muddles Liability In Drug Injury Suits (Law 360-$)
  • FDA allows OTC of Sanofi's Nasacort (Pharma Letter-$) (Tan Sheet-$) (MedPage Today) (Fierce)
  • FDA to review Xolair sBLA for chronic idiopathic urticarial (BioCentury) (SCRIP-$)
  • Execution drugs mixed by U.S. pharmacies draw challenges from death row (Reuters)
  • Teva Announces FDA Approval of Generic TOBI in the United States (Press) (Pharma Letter-$)
  • Coronado's worm therapy fails in Crohn's trial (SCRIP-$) (Bloomberg)
  • FDA Approves ANDA for Mylan's Ziprasidone HCl (Brand: Geodon) (FDA)
  • FDA Agrees with Omeros' Pediatric Study Plan for OMS302 (Press)

US: Pharmaceuticals and Biotechnology: General

  • Florida to execute man using untried lethal injection drug (NBC)

US: Medical Devices

  • $18.4 Million In User Fees Left In CDRH's Coffers, How Long Will It Last? (Gray Sheet-$)
  • FDA Proposal For Cybersecurity Info In Pre-market Submissions Generates Debate (Gray Sheet-$)
  • Rep. Marsha Blackburn working on legislation to clarify FDA's authority over mobile health apps (Gray Sheet-$) (GovHealthIT)
  • FDA approves easy-to-use injectable methotrexate for RA, psoriasis, juvenile arthritis (Press) (DSN) (MedPage Today) (SCRIP-$)
  • Myriad Genetics moves higher on successful melanoma test results (MarketWatch)
  • September 2013 510(k) Clearances (FDA)
  • Brief Summary of the Circulatory System Devices Panel Meeting - October 9, 2013 (FDA)

US: Assorted And Government

  • FDA's Old Guard Fades Away in Enforcement Shakeup (MDDI)
  • US FDA inspectors face "huge backlog" when Shutdown eventually ends (In-Pharma)
  • Hospital's Limit On Supplements Sparks Industry Criticism (Tan Sheet-$) (Nutra Ingredient)
  • Scientists Find Meth-Like Chemical in Bodybuilding Supplement (Food Safety News) (NSF) (CBS)
  • Large Simple Trials Need FDA Boost, IoM Report Says (Pink Sheet-$)
  • Former FDA Commissioner Joins J&J Board (DD&D) (BioCentury) (Pharmalot) (DSN)
  • Contamination & substitution present in many herbal products, but is DNA barcoding of herbals fit for purpose? (Nutra Ingredients)
  • Dendrobium, PEA Supplements Carry Risks For Manufacturers (Tan Sheet)
  • SCRIP's US Capitol Capsule (SCRIP-$)
  • The latest medical device excise tax opponents: Puppies? (MedCity News)
  • Shared responsibility and the medical device tax (Health Stew)

Upcoming Meetings And Events

  • 16 October 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 16 October 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 17-18 October 2013: Anti-Infective Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 22-23 October 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA)
  • 24-25 October 2013: Antiviral Drugs Advisory Commitee Meeting (FDA) (Day 2)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • ENVI Posts Amended Text of IVD Legislation (ENVI) (Clinica-$)
  • Spaniards sue German firm over thalidomide (AP)
  • Legal recourse against delegated and implementing acts in the medical devices regulation (Medical Devices Legal)
  • EMA encourages companies to submit quality type I variations for 2013 by end of November (EMA)
  • Authorized: Vipdomet, Apoquel, Incresync
  • Celgene warns UK docs of Imnovid birth defects risk (Pharma Times)
  • Boehringer Ingelheim submits MAA for nintedanib (BI) (PMLive) (BioCentury) (Pharma Times) (Pharma Letter-$)
  • Janssen Submits Marketing Authorisation Application to European Medicines Agency for a Fixed-Dose Combination Tablet of HIV-1 Medicine Darunavir with Cobicistat (Press)
  • Contraceptive safety concerns to be put to bed in EU (SCRIP-$)
  • UK's NICE reconsiders backing for lymphoma drug Pixuvri (Pharma Letter-$) (SCRIP-$) (Pharma Times)
  • St. Jude Medical Announces CE Mark Approval of World's First Leadless Pacemaker (Press)
  • Research on alternative testing methods contributes to improving the overall welfare of animals (PharmaNewsEU)

Asia

  • UK health regulator withdraws certification of Wockhardt unit (India Times) (DD&D) (Fierce) (Pharmalot)
  • Bayer challenges IPAB's compulsory licence order to Natco Pharma on cancer drug Nexavar (India Times) (Pharmalot)
  • 'Indian government must take call on pharma regulation' (Pharma Africa)
  • India Health Panel Urges No Trials For Drugs Four Years On Some Markets (PharmaAsia-$)
  • Central labs under India's CDSCO report 118 cases of substandard drugs in 11 months (PharmaBiz)
  • Indian Health Ministry yet to decide on prohibiting sale of FDCs approved without DCGI nod (Pharmabiz)
  • Japan Mulls Three-Year Internet Sale Ban For Newly OTC Drugs (PharmAsia-$)

Other International

  • Ghana FDA defends blanket ban after calling Bliss' anti-malaria drug 'fake' (In-Pharma)
  • Stem cell rules clear and adequate, says Philippines FDA (Pharma Letter-$)

General Regulatory And Interesting Articles

  • Delaying Vaccination Is Not a Safer Choice (JAMA) (TIE)
  • Incorporating adverse event relatedness into dose-finding clinical trial designs (Wiley)
  • Network meta-analysis of randomized clinical trials: Reporting the proper summaries (Sage)
  • Demand outweighing supply for compliance officers (Inside Counsel)
  • Bristol-Myers, Merck and Roche Develop Drugs to Zap Tumors Via Immune System (WSJ-$)

Regulatory Reconnaissance #178 - 14 October 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 news@raps.org.


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