Regulatory Focus™ > News Articles > Regulatory Reconnaissance (9 May 2013)

Regulatory Reconnaissance (9 May 2013)

Posted 09 May 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

In Focus: International

  • Health Canada Releases New CGMP Standards, Will Cover APIs (Health Canada)
  • Israeli Ministries want less waiting for clinical trials (Jerusalem Post)
  • Greece Instituting New System for Monitoring Pharmaceutical Products (The Capital)
  • UK Experts call for transparency over medical devices (The Telegraph)
  • Don't link compulsory licensing with price: Pharma companies (India Times)

Comments? Suggestions? Shoot me an email at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA Saving the Pharma Industry With Faster Drug Approvals (Reuters)
  • House Panel Approves Prescription Drug Tracking Bill (Law 360) (SCRIP Intelligence) (The Pink Sheet) (The Hill) (E&C) (BioCentury)
  • Bill Would Put Squeeze On FDA Over Antibiotic Resistance (The Bill) (Law 360) (Pew) (The Hill) (The Consumerist)
  • US FDA accepts Merck & Co's BLA ragweed pollen allergy immunotherapy (The Pharma Letter) (PMLive) (SCRIP Intelligence) (Merck) (Pharma Times) (AP) (BioCentury)
  • FDA inspection triggers recall by Fla. compounding pharmacy (AP) (FDA) (FDA)
  • FDAAA Impact Analysis (Year 5): The REMS Paradox (RPM Report)
  • Neutraceutical Manufacturer XYMOGEN identifies allergen oversight by third-party manufacturer; issues recall of artriphen (FDA)
  • FDA Approves Four Gemcitabine HCl ANDAs: Sagent Pharmaceuticals' (#091597), Pharmaforce's (#202031), Jiangsu Hansoh Pharmaceuticals' (#202485) and Dr. Reddy Laboratories' (#202997) (FDA)
  • FDA Approves ANDA for Zoledtonic Acid (#202571) manufactured by unknown company (FDA)
  • Amgen Late-Stage Trial of Colon Cancer Drug Meets Goal (BioSpace)
  • AbbVie, Teva Pay-For-Delay Deal Draws More Antitrust Claims (Law 360)
  • New Jersey Looking to Establish Drug Repository Program (Scout)
  • Orphan Drug Companies Might Not Find A Parent (Forbes)
Medical Devices
  • U.S. Justice Dept. closes St. Jude Riata probe (Mass Device)
  • CDRH Ponders Ways IDEs Can Boost Innovation (MDDI)
  • Elixir Medical Announces FDA Approval to Commence EXCELLA III Clinical Trial with DESyne Nx Novolimus Eluting Coronary Stent System in the United States (Business Wire)
  • EU Regulations May Affect U.S. Devices Manufacturers Earlier (Medical Device Summit)
  • Three April FDA clearances for smartphone-enabled diabetes devices (Mobi Health News)
  • Masimo lands FDA win for pediatric acoustic sensor (Mass Device)
Assorted
Government and Budget
  • Congress Considers Limits on "Sue and Settle" Lawsuits (RegBlog)
  • H.R.1891 - To establish a position of Science Laureate of the United States (Congress) (Senate Version)
  • S.907 - A bill to provide grants to better understand and reduce gestational diabetes, and for other purposes (Congress)
  • S.908 - A bill to amend the Public Health Service Act to improve the diagnosis and treatment of hereditary hemorrhagic telangiectasia, and for other purposes (Congress)
Upcoming Meetings and Events
  • 7-8 May 2013: House Hearing on Track and Trace (House)
  • 8-9 May 213: Summit on Color in Medical Imaging (FDA)
  • 8 May 2013: Vaccines and Related Biological Products Advisory Committee (FDA)
  • 8 May 2013: Intelligence Squared Debate: Is FDA's Caution Harzardous to our Health? (IQ2)
  • 9 May 2013: Senate HELP Committee Hearing on Pharmaceutical Compounding and its Proposed Legislative Solution (Senate)
  • 9 May 2013: FDA Listening Tour on Antibiotic Resistance (FDA)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • 17 May 2013: NCATS Meeting (NCATS)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • Health Canada Releases New CGMP Standards, Will Cover APIs (Health Canada)
  • Israeli Ministries want less waiting for clinical trials (Jerusalem Post)
  • Greece Instituting New System for Monitoring Pharmaceutical Products (The Capital)
  • Topiroxostat, pertuzumab get preliminary Japan nod (SCRIP Intelligence)
  • Don't link compulsory licensing with price: Pharma companies (India Times)
  • UK Experts call for transparency over medical devices (The Telegraph)
  • Proposed Medical Device Regulation Too Lax, Say NICE and German Researchers (Medtech Insider)
  • Medical Council of India asks doctors to prescribe drugs with generic names (PharmaBiz)
  • St. Jude Medical Announces CE Mark Approval of Next-Generation Ellipse and SJM Assura High Voltage Devices (Business Wire)
  • Abbott Announces CE Mark for Test to Aid Doctors with Diagnosing and Monitoring Diabetes (Abbott)
  • India's APPCB issues notices to 33 bulk drug units to shut below ground level effluent storage tanks (PharmaBiz)
  • Top generic drugmakers like Ranbaxy, Cipla & Sun Pharma look to US as patents end (India Times) (Fierce Pharma)
  • Japan Novartis Files Additional Indication Of Afinitor For Breast Cancer (PharmAsia News)
  • Value-based pricing "not in patient interest," says think tank (PMLive)
  • England's Cancer Drugs Fund widens; Scotland urged not to follow (Pharma Times)
  • Merck, Glaxo Reduce HPV Vaccine Prices in Poorest Regions (Bloomberg)

General Regulatory and Interesting Articles

  • The name's still the thing for biosimilars (SCRIP Intelligence)
  • Source code: PharmaSecure goes mobile in battle against fake drugs (The Guardian)
  • Gene replacement in pigs ameliorates cystic fibrosis-associated intestinal obstruction (EurekAlert)
  • Biosensor that detects antibiotic resistance brings us one step closer to fighting superbugs (EurekAlert)
  • Designs for randomized phase II clinical trials with two treatment arms (Statistics in Medicine)
  • Participants' perspectives on safety monitoring in clinical trials (Clinical Trials)

Regulatory Reconnaissance #63 - 9 May 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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