Regulatory Focus™ > News Articles > Regulatory Reconnaissance (24 May 2013)

Regulatory Reconnaissance (24 May 2013)

Posted 24 May 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Focus will be observing Memorial Day in the US on 27 May and will resume normal operations on 28 May.

In Focus: US

  • J&J Announces 10 Potential Products to Seek FDA Approval by 2017 (J&J) (Fierce) (Pharma Times) (BioCentury)
  • Watson Files Citizen Petition Asking FDA Not to Approve Generic Rapaflo (FDA)
  • FDA Intends to Finalize Mobile Medical Apps Guidance by End of 2013 (Bloomberg)
  • Why Fighting FDA Over its Jurisdictional Authority Could Become More Difficult (SCOTUS Blog)
  • FDA Issues High Number of Form 483s to Supplement Manufacturers (Natural Products Insider)
  • States Becoming More Aggressive Prosecuting Off Label Promotion (Policy and Medicine)

In Focus: International

  • France: Drugmaker on trial, suspected in deaths (AP)
  • Indian Company Wockhardt acknowledges FDA ban, says it could cost $100M (Fierce) (Reuters) (India Times) (PharmAsia News)
  • J&J Recalls 3 Million Tylenol Bottles Yanked in Brazil (Pharmalot)
  • EMA Updates CGMP Q&A Document to Clarify Several Points (EMA)
  • EC Releases Summary of Public Comments on ATMP Regulation (EC)

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

US

Pharmaceuticals/Biotechnology
  • J&J Announces 10 Potential Products to Seek FDA Approval by 2017 (J&J) (Fierce) (Pharma Times) (BioCentury)
  • Merck & Co drops Parkinson's prospect preladenant (PMLive) (Business Wire) (The Pharma Letter) (BioCentury)
  • Watson Files Citizen Petition Asking FDA Not to Approve Generic Rapaflo (FDA)
  • Lupin Pharmaceuticals' Citizen Petition Calls for FDA to Determine if Banzel Was Withdrawn for Safety/Efficacy Reasons (FDA)
  • Study calls for crackdown on 'reckless' drug compounders (The Hill)
  • Janet Woodcock's Testimony to the House Energy and Commerce Committee (FDA)
  • FDA Approves Efficacy Supplement for Centocor Ortho Biotech's Stelara (BLA #125261)
  • Cash-strapped biotech fails PhIII test for pioneering Fragile X drug (Fierce)
  • Johnson & Johnson Is Reinventing The Party Drug Ketamine To Treat Depression (Forbes) (Reuters)
  • AbbVie Price Boost of Drug Slammed in Studies Criticized (Bloomberg)
  • AVEO slides as Astellas shuns tivozanib in kidney cancer (SCRIP Intelligence)
  • Novo obesity drug could launch in U.S. end 2014 (Reuters) (BioCentury)
  • Hydrocodone Decision Delay Reflects Industry Tensions (FDA News)
  • Two Pakistani Nationals Extradited to District of Columbia to Face Charges Involving Illegal Pharmaceutical Shipments (FDA)
  • Meeting of the National Vaccine Advisory Committee (DHHS)
  • National Vaccine Injury Compensation Program; List of Petitions Received (HRSA)
  • Celgene's Abraxane gets a September 2013 PDUFA Date (SCRIP Intelligence) (BioCentury)
Medical Devices
  • FDA Intends to Finalize Mobile Medical Apps Guidance by End of 2013 (Bloomberg)
  • Busy week for FDA and mobile health, but no final guidelines yet (Mobi Health News)
  • Mobile health apps could cut into established companies' market share (IBJ)
  • Nephosity's medical image viewing app gets FDA nod for use in remote diagnosis (Med City News) (MedGadget)
  • Endochoice Fuse Receives FDA Clearance; Reduces Colonoscopy Miss Rate (VIDEO) (MedGadget)
  • Federal Judge Approves Class Action Settlement Over Dental Implants (Lexis Nexis)
  • Covidien Releases Results from First-in-Human Study of New Drug-Coated Balloon (Business Wire)
Assorted and Government
  • Why Fighting FDA Over its Jurisdictional Authority Could Become More Difficult (SCOTUS Blog)
  • FDA Issues High Number of Form 483s to Supplement Manufacturers (Natural Products Insider)
  • States Becoming More Aggressive Prosecuting Off Label Promotion (Policy and Medicine)
  • Bipartisan bill would overhaul regulatory system, target 'mega-rules' (The Hill)
  • Testimony: FDA's Activities Related to China (FDA)
  • When Regulators are Ignored (FDA)
  • Does the Federal Register Need to be Reformed? (Forbes)
  • Portman, Pryor Renew Push to Reduce Red Tape on Job Creators (Pryor)
  • House committee plans deep 2014 spending cuts (Federal Times)
Upcoming Meetings and Events
  • 21 May 2013: First-Ever Patient Network Town Hall (FDA)
  • 21-22 May 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 22 May 2013: Markup of Senate Compounding, Track and Trace Legislation (HELP)
  • 22 May 2013: Congressional Hearing: "Food and Drug Safety, Public Health, and the Environment in China" (CECC)
  • 22 May 2013: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
  • 22 May 2013: CVM's New Animal Drugs for Use in Feeds Workshop (FDA)
  • 23 May 2013: Energy and Commerce Committee Hearting, "Examining Drug Compounding" (E&C) (Janet Woodcock to Testify)
  • 23 May 2013: Reagan-Udall Foundation Annual Open Public Meeting (RU)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • France: Drugmaker on trial, suspected in deaths (AP)
  • Indian Company Wockhardt acknowledges FDA ban, says it could cost $100M (Fierce) (Reuters) (India Times) (PharmAsia News)
  • J&J Recalls 3 Million Tylenol Bottles Yanked in Brazil (Pharmalot)
  • EMA Updates CGMP Q&A Document to Clarify Several Points (EMA)
  • EU to kick off talks on stronger trade mark system (SCRIP Intelligence)
  • EC Releases Summary of Public Comments on ATMP Regulation (EC)
  • Korean case marks more quality woes for J&J (SCRIP Intelligence)
  • TGA Could Righten Rules on Xanax (The Examiner)
  • New Pharma Standards in China Paves the Way for Higher Standards and Increased Competition (Eye for Pharma)
  • Mens rea proof may be key to Daiichi legal action against Singh bros amid war of words (SCRIP Intelligence)
  • Singh Family (The Former Shareholders and Founders of Ranbaxy) Hit Back as Daiichi Sankyo (PR Newswire)
  • Indian firms trade insults over 'inaccurate' Pfizer lobbying (SCRIP Intelligence)
  • Astellas and Medivation Announce Submission of Application for Marketing Approval of Enzalutamide, an Oral Androgen Receptor Inhibitor, in Japan (Business Wire) (SCRIP Intelligence)
  • Astellas set for more Vesomni approvals after Netherlands nod (SCRIP Intelligence)
  • AbbVie and Eisai Announce HUMIRA® Pre-filled Syringe Has Received Approval for the Treatment of Intestinal Behçet's Disease in Japan (Eisai)
  • NHS accused of incompetence over Tamiflu stockpiling (RPS)
  • Novartis Acknowledges Employees Participated In 'Independent' Trials (Forbes)

General Regulatory and Interesting Articles

  • Tufts CSDD Study Finds Adoption of Adaptive Clinical Trial Designs Is Increasing (Business Wire)
  • Debunking Myths About Biotech Venture Capital (Life Sci VC)
  • Liability for Failure to Vaccinate (Harvard)
  • Telemedicine in the Clinical Trial Space (Lilly COI)
  • Seeing Double: Errors In Stem-Cell Cloning Paper Raise Doubts (NPR)

Regulatory Reconnaissance #74 - 24 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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