Regulatory Focus™ > News Articles > Regulatory Reconnaissance (21 November 2013)

Regulatory Reconnaissance (21 November 2013)

Posted 21 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's Dr Fabricant: GMP violations are staying the same, and that's a concern (Nutra Ingredients)
  • FDA Device Chief Says House HIT Bill Could Prevent Agency From Evolving (IHP-$)
  • Preventing medical device recalls: What's expected for internal audits? (Mass Device)
  • Forest Laboratories and Gedeon Richter Receive Complete Response Letter for Antipsychotic Cariprazine (Press) (Reuters) (Pharma Times) (PMLive)
  • FDA Grants Approval to Pfizer's Xalkori (FDA)

In Focus: International

  • Getting new drugs to market safely: an interview with the new chief executive of the MHRA (PJOnline)
  • EU Regulators/HTAs Alliance Lacks Specifics On Trial Comparators (Pink Sheet-$)
  • Spanish Court Finds Grunenthal Liable In Thalidomide Case (Law 360-$)
  • Further signs that ANVISA may ease Brazilian GMP requirements (Mass Device)
  • Japan passes landmark regenerative medicine bills (SCRIP-$)

US: Pharmaceuticals/Biotechnology

  • FDA Grants Approval to Pfizer's Xalkori (FDA)
  • Forest Laboratories and Gedeon Richter Receive Complete Response Letter for Antipsychotic Cariprazine (Press) (Reuters) (Pharma Times) (PMLive)
  • Summary of the DQSA's Compounding Provisions (FDA Law Blog-PDF)
  • Meta-analysis contradicts FDA's findings on dabigatran (Cardiovascular Business)
  • DQSA: Getting To Electronic Transaction Data Exchange (RxTrace)
  • Kyowa Kirin gives Parkinson's drug another shot under SPA (SCRIP-$)
  • GNC Hit With Suit Linking Supplement To Hepatitis (Law 360-$)
  • Massachusetts Biosimilar Substitution Bill Advances (Scout)
  • Meeting of the Chronic Fatigue Syndrome Advisory Committee (DHHS)
  • Researchers Back Peddle From Their Own Risperdal Study (Pharmalot)
  • U.S. gathers vaccine researchers to talk bioterrorism threat Q fever (Fierce)
  • FDA vs Modern Medicine: Q/A w Peter Huber (Reason)

US: Pharmaceuticals and Biotechnology: General

  • Generic or Name-Brand? 10 Docs Talk About Picking Drugs (ProPublica)
  • Concerns About Pharma-Sponsored Research Removed From PCORI Methodology Report (Pink Sheet-$)
  • Medication Adherence: A Positive Story You Are Not Hearing (In Vivo-$)

US: Medical Devices

  • FDA Device Chief Says House HIT Bill Could Prevent Agency From Evolving (IHP-$)
  • Preventing medical device recalls: What's expected for internal audits? (Mass Device)
  • CEO's advice on how to fund a medical device that's PMA route, win support (MedCity News)
  • Shuren: Gene Sequencing Devices Are 'Next Generation' (FDA)
  • Class 1 Recall for Anesthesia Machine (FDA)
  • TauTona Group wins 510(k) clearance for tissue injector (Mass Device)
  • Medtronic touts early results for Valiant Mona LSA (Mass Device)
  • Dallen Medical Receives FDA 510(k) Clearance for Its Tensyn Band for Syndesmosis Repair (Press)
  • Positive Clinical Results on the use of Bacterin's OsteoSponge (Press)

US: Dietary Supplements

  • FDA's Dr Fabricant: GMP violations are staying the same, and that's a concern (Nutra Ingredients)

US: Assorted And Government

  • GAO wants updated consumer privacy framework (Fierce)

Upcoming Meetings And Events

  • 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

  • Getting new drugs to market safely: an interview with the new chief executive of the MHRA (PJOnline)
  • EU approves Otsuka/Lundbeck's Abilify Maintena (Pharma Times) (Pharma Letter-$)
  • EU approval for Sobi's ex-Amgen product in rare disease CAPS (SCRIP-$) (BioCentury)
  • EU Regulators/HTAs Alliance Lacks Specifics On Trial Comparators (Pink Sheet-$)
  • Spanish Court Finds Grunenthal Liable In Thalidomide Case (Law 360-$)
  • EU generics firms want parity with Canada on drug exports (SCRIP-$)
  • EFPIA: Disclose payments or face legislation (PMLive)

Asia

  • Japan passes landmark regenerative medicine bills (SCRIP-$)
  • India's dangerous drug problem (AEI)
  • AstraZeneca And Pfizer Call For Measures To Avoid Mix-up Between Nolvadex And Norvasc In Japan (PharmAsia-$)
  • TriReme Medical notches another Japanese win (Mass Device)
  • Shionogi Files For Approval Of Vancomycin For Methicillin-Resistant Coagulase-Negative Staphylococci In Japan (PharmAsia-$)

Other International

General Regulatory And Interesting Articles

  • The Law of 'Not Now': When Agencies Defer Decisions (SSRN)
  • Cholesterol Drug From Trash Seen Preventing Heart Attack (Bloomberg)
  • Condom Contest Produces 812 Ideas for Improvement (NYTimes)
  • Gaming meets nursing: Innovative glasses can see through patients' skin to find best veins (MedCity News)
  • Discovery of brain activity in severely brain injured patients who 'wake up' w/ sleep drug (EurekAlert)

Regulatory Reconnaissance #207 - 21 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.


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