Regulatory Focus™ > News Articles > Regulatory Reconnaissance (4 December 2013)

Regulatory Reconnaissance (4 December 2013)

Posted 04 December 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 Warns on Skin Reactions With Clobazam (MedPage Today) (FDA) (FDA)
  • A "Torrent of Studies" on Direct-to-Consumer Advertising: Is FDA Shoring Up Its Defenses? (Harvard Bill of Health)
  • Purdue Petition Seeks FDA Commitment To "Adapted" Studies For OxyContin Generics (Pink Sheet-$)
  • Reagan-Udall Foundation Releases New IMEDS Report on Medical Evidence (RUF)
  • A Miracle Drug Cured Ed Levitt of Stage IV Lung Cancer. Then the FDA Withdrew it From the Market (Reason)
  • Rare Cancer Treatments, Cleared by FDA but Not Subject to Scrutiny-The HDE Pathway (NYTimes)
  • FDA Issues Warning on Philips Healthcare Defibrillators (WSJ-$) (Fierce) (FDA) (FDA) (FDA)

In Focus: International

  • Industry says asking QPs to know laws in all EEA markets is 'unrealistic' (In-Pharma)
  • 'Multiple morbidities' greatest NICE challenge (SCRIP-$)
  • ICH Reviews Future ICH Topics and Its Organization Towards Increased Engagement Globally (ICH)
  • India to showcase drugmaking facilities to global regulators (India Times)
  • Update On China's National GMP Certification Progress (PharmAsia-$)
  • Thailand Probes Compulsory License Clopidogrel Purchasing Woes (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • FDA Warns on Skin Reactions With Clobazam (MedPage Today) (FDA) (FDA)
  • A "Torrent of Studies" on Direct-to-Consumer Advertising: Is FDA Shoring Up Its Defenses? (Harvard Bill of Health)
  • Purdue Petition Seeks FDA Commitment To "Adapted" Studies For OxyContin Generics (Pink Sheet-$)
  • Reagan-Udall Foundation Releases New IMEDS Report on Medical Evidence (RUF)
  • A Miracle Drug Cured Ed Levitt of Stage IV Lung Cancer. Then the FDA Withdrew it From the Market (Reason)
  • New FDA MAPP: Good Review Practice: Clinical Review of Investigational New Drug Applications (FDA)
  • Risky Business - Risk Information and Promotion (Eye on FDA)
  • FDA Addresses Continued Shortage of Drug Used to Treat Heartworm Infection in Dogs (FDA)
  • Analyst who cast doubt on Provenge vaccine settles with SEC (Reuters) (Pharmalot)
  • FDA gives tentative approval to Roxane pneumonia drug (DSN)
  • Roxane Labs' generic prostate drug gets tentative approval from FDA (DSN)
  • Exact Sciences Announces Date for FDA Advisory Committee Meeting (Press)
  • Astellas isavuconazole gains FDA 'infectious disease' status (SCRIP-$)
  • Immunomedics Announces Orphan Drug Designation for IMMU-132 for Small Cell Lung Cancer Therapy (Press)
  • FDA accepts Zalviso NDA; AcelRx rises (SCRIP-$)
  • California Stem Cell Announces U.S. FDA Approval of Phase III Cancer Stem Cell Clinical Trial for Metastatic Melanoma (Press)
  • Conatus' Liver Transplant Drug Gets Orphan Designation (DD&D)
  • AstraZeneca Deserves $76M In Drug Patent Suit, Judge Says (Law 360-$) (Reuters) (Fierce) (Press)
  • Meningitis outbreaks at Princeton, UC Santa Barbara prompt concern, vaccine efforts (Washington Post)

US: Pharmaceuticals and Biotechnology: General

  • California County Drug Disposal Program: Unconstitutional? (Forbes) (Bellevue Reporter) (Pharmalot)
  • ASCO "Top 5" List Turns Up Rhetorical Heat On Cancer Drug Prices, aka "Financial Toxicity" (RPM Report-$)
  • Biopharma's return on R&D spend is half what it was in 2010, report says (Fierce)
  • Reports: R.I. may set up prescription drug registry to combat abuse (DSN)

US: Medical Devices

  • Rare Cancer Treatments, Cleared by FDA but Not Subject to Scrutiny-The HDE Pathway (NYTimes)
  • FDA Issues Warning on Philips Healthcare Defibrillators (WSJ-$) (Fierce) (FDA) (FDA) (FDA)
  • CMS Will Switch To Centralized Coverage Review Of IDE Trials, But Not Until 2015 (Gray Sheet-$)
  • Fed agencies aim for mHealth regulatory balance (mHealth News)
  • Staar Surgical's Toric ICL vision-correcting lens gets a date with the FDA (Mass Device)
  • TAVI: Claret Medical asks FDA to approve Sentinel trial (Mass Device)
  • Bard bellwether mesh trial delayed until 2014 (Mass Device)
  • Cerus Submits Final Module in the Premarket Approval (PMA) Application Process for INTERCEPT Plasma (Press)
  • PrimeraDx Receives 510(k) Clearance from FDA for ICEPlex C. difficile Assay Kit and ICEPlex System (Press)
  • Oculus Innovative Sciences Receives FDA Clearance for Microcyn(R) Scar Management HydroGel
  •  (Press)
  • Cochlear Announces the FDA Clearance of the Baha 4 Attract System, the First Magnetic Baha Bone Conduction Hearing Device (Press)
  • August 2013 PMA Approvals (FDA)

US: Dietary Supplements

  • USPlabs Slapped with Second Lawsuit in OxyElite Pro Outbreak (NPI)

US: Assorted And Government

  • Many trial results in ClinicalTrials.gov not published (Press) (PLoS) (Nature)
  • New FDA Warning Letters Posted (FDA)
  • McInnes Named NCATS Deputy Director (NIH)
  • Obama should take tough line on trade talks, says Hatch (FT)
  • Chamber of Commerce Declare War on 'vast regulatory state' (The Hill)
  • USA's BIO expresses serious concerns on Innovation Act, HR 3309 (Pharma Letter-$)

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)
  • 11 December 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 11-12 December 2013: Allergenic Products Advisory Committee Meeting (FDA)
  • 12 December 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Durata submits dalbavancin MAA (BioCentury)
  • Draft sunitinib product-specific bioequivalence guidance (EMA)
  • Industry says asking QPs to know laws in all EEA markets is 'unrealistic' (In-Pharma)
  • 'Multiple morbidities' greatest NICE challenge (SCRIP-$)
  • Norway to compare Hospira knockoff with J&J's Remicade to goose biosimilars market (Fierce)
  • UK PPRS published, but industry discord remains (Pharma Times)

Asia

  • India to showcase drugmaking facilities to global regulators (India Times)
  • Johnson & Johnson faulty implants: Indians left in lurch due to 'differential treatment' compared to US counterparts (India Times)
  • Update On China's National GMP Certification Progress (PharmAsia-$)
  • Thailand Probes Compulsory License Clopidogrel Purchasing Woes (PharmAsia-$)

Other International

  • ICH Reviews Future ICH Topics and Its Organisation Towards Increased Engagement Globally (ICH)
  • ICH MedDRA Management Board Supports MedDRA's Continued Evolution and High Quality Maintenance (ICH)

General Regulatory And Interesting Articles

  • Patients do not appreciate life-saving pharma: Bayer chief (Pharma Times)

Regulatory Reconnaissance #214 - 4 December 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