Regulatory Focus™ > News Articles > Regulatory Reconnaissance (19 July 2013)

Regulatory Reconnaissance (19 July 2013)

Posted 19 July 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • FDA Fees to Review Drugs, Devices Would Be Unfrozen in House Bill (Bloomberg) (Legislation) (The Hill) (Rep. Lance) (Mass Device) (BioCentury) (FDA Law Blog) (AdvaMed)
  • FDA Asserts Right to Take Photos During Inspections, but Does that Authority Exist in Statute? (FDA Law Blog)
  • Massachusetts Advances Legislation to Require Prescription Drug Adverse Event Reporting (Legislation) (SCOUT)
  • BIO Releases New Survey on Effective FDA/Sponsor Communication During Drug Development to Assist PDUFA Implementation (BIO)
  • FDA Announces Workshop on Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
  • US and EU Regulatory Authorities Accept Biogen Idec's Plegridy Marketing Applications for Review (BI)
  • Intuitive Surgical Declines on Warning Letter From FDA (Bloomberg) (WSJ) (Market Watch) (Fierce)

In Focus: International

  • New EMA Guideline Released on Products to Treat Urinary Incontinence (EMA)
  • EMA Releases Draft Guideline on the Medicinal Products for the Treatment of Irritable Bowel Syndrome (EMA)
  • UK Government Seeks Pharmaceutical Sector's Views on Regulation Enforcement (PharmTech)
  • Lucentis and Avastin Equal in Efficacy, Study Finds (Pharmafile)
  • China FDA Appoints New Deputy Commissioner (PharmAsia)
  • UCB Visited by Chinese Authorities Amid GSK Probe (Bloomberg) (Pharma Times)
  • Will GSK's China Damage Control Include a Visit from Andrew Witty? (SCRIP)
  • India's Pioglitazone Fiasco Reignites Criticism of Regulatory Process (PharmAsia)
  • India's Medical Device Industry Wants Government to Ensure Quality of Components and Raw Materials (PharmaBiz)
  • India's ISCR Welcomes Decision to Relax Norms on Compensation for Injury or Death in Clinical Trials (PharmaBiz)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA Asserts Right to Take Photos During Inspections, but Does that Authority Exist in Statute? (FDA Law Blog)
  • Massachusetts Advances Legislation to Require Prescription Drug Adverse Event Reporting (Legislation) (SCOUT)
  • BIO Releases New Survey on Effective FDA/Sponsor Communication During Drug Development to Assist PDUFA Implementation (BIO)
  • FDA Announces Workshop on Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
  • US and EU Regulatory Authorities Accept Biogen Idec's Plegridy (peginterferon beta-1a) Marketing Applications for Review (BI)
  • Pfizer enters final settlements in 660 Chantix lawsuits (Birmingham News)
  • Armagen Receives US Orphan Designation For Lead Product AGT-182 (Armagen)
  • FDA Withdraws Marketing Applications of Dozens of Discontinued Medicines (FDA)
  • MAPP: Determining the Established Pharmacologic Class for Use in the Highlights of Prescribing Information (FDA)
  • MAPP: CDER Master Data Management  (FDA)
  • Feds Probe Novartis Over Marketing Of Its Gilenya MS Pill (Pharmalot) (SCRIP)
  • FDA Approves Spear Pharmaceuticals' ANDAs for Tretinoin (Renova, Atralin, Refissa, Avita)(#202026, 202567) and a Tentative Approval for Paddock Labs' Repaglinide (Prandin) (#201189) (FDA)
  • Janssen gains US OK for Simponi Aria in RA; 1st infusible TNF (SCRIP)
  • Novartis' dovitinib misses in Phase III RCC trial (BioCentury)
  • Ranbaxy Sues First Databank For Trade Libel Over Acne Drug (Law 360)
  • FDA approves generic version of Trilipix (DSN)
  • Merck Pays $23 Million to End Vioxx Drug-Purchase Suits (Bloomberg)
Medical Devices
  • Intuitive Surgical Declines on Warning Letter From FDA (Bloomberg) (WSJ) (Market Watch) (Fierce)
  • Stop the Clocks: Baxa Recall for Compounding Device Due to Potential Clock Battery Failure (FDA)
  • Spinal Restoration, Inc. Announces Disappointing Phase III Study Results for the Biostat System (SR)
Assorted And Government
Upcoming Meetings And Events
  • 16 July 2013: Hearing: Reforming the Drug Compounding Regulatory Framework (House)
  • 18 July 2013: Meeting: Dental Products Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 18 July 2013: Meeting: Anesthetic and Analgesic Drug Products Advisory Committee (FDA)
  • 22-23 July 2013: Arthritis Advisory Committee Meeting (FDA)
  • 23 July 2013: Brookings Webinar: Active Medical Product Surveillance Roundtable (FDA)
  • 24 July 2013: House Hearing on US-EU Free Trade Agreements and Regulatory Barriers (House)
  • 25 July 2013: CBER Webinar on its Direct Recall Classification Program (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • New EMA Guideline Released on Products to Treat Urinary Incontinence (EMA)
  • EMA Releases Draft Guideline on the Medicinal Products for the Treatment of Irritable Bowel Syndrome (EMA)
  • CHMP Meeting on 22-25 July (EMA)
  • COMP Minutes from 9-11 July 2013 Meeting (EMA) (EMA)
  • Best expertise vs conflicts of interests: Striking the right balance (Meeting) (EMA)
  • UK Government Seeks Pharmaceutical Sector's Views on Regulation Enforcement (PharmTech)
  • EU and the US extend scientific co-operation on standards and measurements (EC)
  • European regulator to review Zolpidem's effect on driving (PJO)
  • Veterinary medicines legislation under review (PJO)
  • UK launch for Astellas' prostate cancer drug (Pharma Times)
  • Lucentis and Avastin equal in efficacy (Pharmafile)
  • France Issues Warning on Use of HES Starch (ANSM)
  • MHRA Recalls Intra-Oral Dental X-Ray Units Manufactured by Trophy Due to Faulty Wall Bracket Mounting (MHRA)

Asia

  • China FDA Appoints New Deputy Commissiner (PharmAsia)
  • UCB Visited by Chinese Authorities Amid Glaxo Probe (Bloomberg) (Pharma Times)
  • GSK China damage control to include Witty visit? (SCRIP)
  • India's Pioglitazone Fiasco Reignites Criticism Of Regulatory Process (PharmAsia)
  • India's Medical device industry wants govt to ensure quality of components & raw materials (PharmaBiz)
  • India's ISCR welcomes decision to relax norms on compensation for injury or death in clinical trials (PharmaBiz)
  • Indian Pharma cos secure final approval for 87 ANDAs from US FDA in Jan-June 2013 (PharmaBiz)

Other International

  • Submissions received: Proposed amendments to the new regulatory framework for In Vitro Diagnostic medical devices (TGA)

General Regulatory And Interesting Articles

  • Tackling multidrug resistance: Reducing pathogen evolution is better than developing new drugs (Med City News)
  • Gates-backed device extends cold chain to rural areas (Fierce)
  • Antiepileptic drug use in pregnancy impacts early child development (OnMedica)
  • HPV Vaccine Found to Help With Cancers of Throat (NYTimes)

Regulatory Reconnaissance #111  - 19 July 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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