Regulatory Focus™ > News Articles > Regulatory Reconnaissance (1 August 2013)

Regulatory Reconnaissance (1 August 2013)

Posted 01 August 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • Sunshine Act Goes into Effect Today - What you Need to Know (Policy and Medicine)
  • FDA Advisory Committee Recommends Approval of Sanofi's Nasacort AQ Nasal Spray for Over-the-Counter Use (Sanofi) (Reuters) (WSJ) (MedPage Today)
  • Proposed Rule Allowing Generic Label Changes Lands At OMB (IHP)
  • Antibiotics Pathway Legislation Gets Continued Push Despite FDA Moves (Pink Sheet) (BioCentury)
  • FDA draft guidance coming under rare disease fire (BioCentury)
  • FDA Posts Warning Letter to Intuitive Surgical (FDA)
  • FDA to scrutinize HPV test linked to false readings (USA Today)
  • FDA warns of massive diabetes test strip recall (NBC) (FDA) (NovaMax)
  • Researchers call for reform in cancer biomarker test space (BioCentury)
  • NIAID Research Consortium Launches TrialShare Portal Containing Open Access to Raw Data (Pharma Times)
  • Brazen Scofflaws? Are Pharma Companies Really Completely Ignoring FDAAA? (Placebo Control)

In Focus: International

  • EMA's Head of Human Medicines Development and Evaluation Patrick Le Courtois Retires After 16 Years of Service (EMA)
  • GSK Trial Data Opened for Other Researchers, Launches Website (MedPage Today) (Bloomberg) (Website)
  • EMA Launches Draft Guidance on Medical Products Intended to Treat Hypertension (EMA) (EMA)
  • GSK has received 40 data requests (BioCentury)
  • Australia's Biosimilar Guidance Builds on EMA Docs (In-Pharma Technologist)
  • India Tells U.S. To Fix Own Drug-Patent Process Before Attacking Others (PharmAsia)
  • Chinese officials visit Sanofi offices amid wider probes (FT)

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

US

Pharmaceuticals/Biotechnology
  • Sunshine Act Goes into Effect Today - What you Need to Know (Policy and Medicine)
  • FDA Advisory Committee Recommends Approval of Sanofi's Nasacort AQ Nasal Spray for Over-the-Counter Use (Sanofi) (Reuters) (WSJ) (MedPage Today)
  • Proposed Rule Allowing Generic Label Changes Lands At OMB (IHP)
  • Antibiotics Pathway Legislation Gets Continued Push Despite FDA Moves (Pink Sheet) (BioCentury)
  • FDA draft guidance coming under rare disease fire (BioCentury)
  • Global Analogs Database Touted To Sharpen Spiked Sexual Supplement Enforcement (Pink Sheet)
  • FDA Introduces Ability to Sort Drug Shortages List by Therapeutic Index (FDA)
  • Vanda, FDA And $500K Bonus Paid To A Mystery Regulatory Consultant (The Street)
  • Lupin receives tentative approval for generic sleeping, rosacea drugs (DSN) (Lupin)
  • FDA approves Perrigo's fluticasone propionate lotion (DSN) (Perrigo)
  • FDA Approves Accord Healthcare's Generic Lisinopril (#202554) and Tentatively Approves Sandoz's Generic Janumet (#202388) (FDA)
  • Oncos Therapeutics Granted Orphan Drug Designation for CGTG-102 in Soft Tissue Sarcoma (STS) by FDA and EMA (Oncos)
  • NIH launches neurological drug development projects (NIH)
  • TechnoVax Awarded NIH Grant to Develop a Universal Flu Vaccine based on its Virus-Like-Particle (VLP) Technology (TechnoVax)
  • FDA's Approval of Truvada Raises Ethical Questions, Say Researchers (EurekAlert)
  • Stratatech Awarded BARDA Contract Valued up to $47.2 Million for Advanced Development of StrataGraft Skin Tissue for Thermal Burns (Stratatech)
  • Suit Over Mumps Vaccine Shows No False Claims, Merck Says (Law 360)
Medical Devices
  • FDA Posts Warning Letter to Intuitive Surgical (FDA)
  • FDA to scrutinize HPV test linked to false readings (USA Today)
  • FDA warns of massive diabetes test strip recall (NBC) (FDA) (NovaMax)
  • Researchers call for reform in cancer biomarker test space (BioCentury)
  • DePuy Issues Class 1 Recall for Femur Replacement Due to Risk of Fracture (FDA)
  • Convergent Dental Receives FDA Clearance For Solea The World's First CO2 Laser System Cleared By FDA For Both Hard & Soft Tissue Use In The Oral Cavity (Convergent)
Assorted And Government
  • NIAID Research Consortium Launches TrialShare Portal Containing Open Access to Raw Data (Pharma Times)
  • Brazen Scofflaws? Are Pharma Companies Really Completely Ignoring FDAAA? (Placebo Control)
  • A Matter Of Trust: Minorities Are Suspicious Of Clinical Trials (Pharmalot)
  • NIH 'blueprint' network aims to speed Sage's Fragile X R&D (SCRIP)
  • FDA Enforcement Report - Week of July 31, 2013 (FDA)
  • When is a permanent injunction not permanent? (Inside Counsel)
  • Bill giving Congress power over regulations draws veto threat (The Hill)
  • House passes bill to help put anti-allergy meds in schools (CBS) (AP)
  • Panel advances bill requiring more scrutiny of federal regs (The Hill)
  • Solicitation of Written Comments on the Draft Report of the National Adult Immunization Standards of Practice for Consideration by the National Vaccine Advisory Committee (DHHS)
Upcoming Meetings And Events
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 29 July 2013: Workshop on Clinical Development Programs for Opioid Conversion (FDA)
  • 30-31 July 2013: Workshop on Battery-Powered Medical Devices (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • 2 August 2013: Blood Products Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA's Head of Human Medicines Development and Evaluation Patrick Le Courtois retires after 16 years of service (EMA)
  • Draft guideline on clinical investigation of medicinal products in the treatment of hypertension (EMA) (EMA)
  • GSK has received 40 data requests (BioCentury)
  • GSK Trial Data Opened for Other Researchers, Launches Website (MedPage Today) (Bloomberg) (Website)
  • Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use (EMA)
  • Concept paper on the need to revise Condition ? Specific guidance, Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man (EMA)
  • Executive Director Decision laying down rules  on the secondment of national experts to the Agency (EMA)
  • Explanatory note on the withdrawal of the note for guidance on harmonisation of requirements for influenza Vaccines (CPMP/BWP/214/96) and of the core SmPC/PL for inactivated seasonal influenza vaccines (CMDh/128/2003/Rev5 and CMDh/129/2008/Rev3) (EMA)

Asia

  • AstraZeneca Salesperson Still Held in China (WSJ)
  • Chinese officials visit Sanofi offices amid wider probes (FT)
  • Japan Second Committee Approve Five New Drugs Including ICS/LABA Inhaler (PharmAsia)
  • India's price controls trigger labeling confusion (Fierce)
  • India Tells U.S. To Fix Own Drug-Patent Process Before Attacking Others (PharmAsia)
  • BMJ editorial: India's research participant protection policy (BMJ)

Other International

  • Australia's Biosimilar Guidance Builds on EMA Docs (In-Pharma Technologist)
  • TGA launches online follow-up and final adverse event reporting for medical devices (TGA)
  • TGA international engagement strategy 2013-2015 (TGA)

General Regulatory And Interesting Articles

  • Pharma excipients 'may affect gastrointestinal tract', says study (Pharmafile)

Regulatory Reconnaissance #122  - 1 August 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