Regulatory Focus™ > News Articles > Regulatory Reconnaissance (7 November 2013)

Regulatory Reconnaissance (7 November 2013)

Posted 07 November 2013 | 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

  • FDA updates warning on Sanofi's blood thinner Lovenox (Reuters) (FDA) (FDA)
  • Former employee approached generic drug maker with fraud suspicions (CBS)
  • FDA Encourages Novel Switch Ideas, Though NSURE Remains Unsure (Tan Sheet-$)
  • FDA, Congress Look To Nationalize Breast Density Reporting Requirements, Now In 13 States (Gray Sheet-$)
  • Dietary Supplement Firms Still Violating Basic Manufacturing Rules (NPI)
  • USPTO's Power To Nix Verdicts Ripe For Supreme Court (Law 360-$)

In Focus: International

  • EMA on track with biosimilars guidance says industry (PMLive)
  • Value-based pricing (VBP) to be delayed in U.K. (BioCentury)
  • French Regulators Make it Easier to Report Adverse Events (ANSM)
  • Japan, Taiwan Sign Drug, Device Regulation Cooperation Pacts (PharmaAsia-$)

US: Pharmaceuticals/Biotechnology

  • FDA updates warning on Sanofi's blood thinner Lovenox (Reuters) (FDA) (FDA)
  • Former employee approached generic drug maker with fraud suspicions (CBS)
  • FDA Encourages Novel Switch Ideas, Though NSURE Remains Unsure (Tan Sheet-$)
  • Close-out Letter a 'pivotal milestone' for AMRI's troubled Burlington plant (Oursourcing Pharma) (Fierce)
  • Catalyst Pharma Fights Greed Charges Over An Orphan Drug (Pharmalot)
  • FDA Sends Expedited Program Guidance to OMB for Review (FDA)
  • Approving, and Suspending, a Dangerous Drug (NYTimes)
  • NovaBay falls on impetigo miss (BioCentury)
  • Coronado partner stops mid-stage study of bowel disease treatment (Reuters)
  • Agenus' HerpV Therapeutic Vaccine for Genital Herpes Meets Primary Endpoint in Randomized Phase 2 Trial (Press) (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • FTC Redefines Which Drug Patent Deals Need Antitrust OK (Law 360-$) (FTC)
  • NIH won't exercise march-in for Norvir patents (BioCentury)
  • Rx Copay Coupons "Discouraged" In Exchange Plans But Not Barred By Anti-Kickback Laws - CMS (Pink Sheet-$)
  • Reports: Rite Aid will no longer sell OTC drugs with pseudoephedrine as only active ingredient in W.Va. (DSN)
  • A New Look At An Old Epilepsy Drug Yields Treatment Clue (NPR)

US: Medical Devices

  • FDA, Congress Look To Nationalize Breast Density Reporting Requirements, Now In 13 States (Gray Sheet-$)
  • FDA Schedules Meeting on Spinal Sphere Devices (FDA)
  • 3 surprises in FDA's mobile medical apps final guidance (GovHealthIT)
  • Gore lands PMA for Viabahn stent graft (Mass Device)
  • Class I Recall for Baylis Medical's TorFlex Transseptal Guiding Sheath Kit (FDA) (FDA) (Cardiovascular Business)
  • Neovasc says Reducer Device Achieves Primary Endpoint in COSIRA Trial, Significantly Improving Function in Patients with Refractory Angina (Press)

US: Dietary Supplements

  • Dietary Supplement Firms Still Violating Basic Manufacturing Rules (NPI)
  • Center For Food Safety To FDA: Don't Answer "Natural" Question In Gruma Lawsuit (Food Product Design)
  • As lawsuits pile up, many big food companies scrap 'all natural' label (Inside Counsel)

US: Assorted And Government

  • USPTO's Power To Nix Verdicts Ripe For Supreme Court (Law 360-$)
  • FDA Enforcement Report - Week of November 6, 2013 (FDA)
  • GMO labeling measure down big in Washington State (The Hill)

Upcoming Meetings And Events

  • 8 November 2013: Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 13 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA on track with biosimilars guidance says industry (PMLive)
  • Value-based pricing (VBP) to be delayed in U.K. (BioCentury)
  • French Regulators Make it Easier to Report Adverse Events (ANSM)
  • Bayer Submits VEGF Trap-Eye (aflibercept solution for injection) for Treatment of Diabetic Macular Edema in the EU (Press) (Reuters)
  • Further Referral by UK Patents Court to CJEU on Interpretation of SPC Regulation for Combination Products (Patent Docs)
  • Public Hearing on the Preliminary Opinion 'Environmental risks and indirect health effects 
  • of mercury from dental amalgam (EC)
  • UAR consults on openness in animal research (Pharma Times)
  • Gore Excluder Iliac Branch Endoprosthesis Is First Dedicated System of Its Kind Approved in Europe (Press)

Asia

  • Japan, Taiwan Sign Drug, Device Regulation Cooperation Pacts (PharmaAsia-$)
  • Deregulation limits attacked as Japan stakes ground over online drug sales (SCRIP-$)

Other International

  • South Africa sets out intellectual property policy, with focus on public health (Pharma Letter-$)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #197 - 7 November 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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe