Regulatory Focus™ > News Articles > Regulatory Reconnaissance (21 August 2013)

Regulatory Reconnaissance (21 August 2013)

Posted 21 August 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Basilea Falls on FDA Request for Two Drug Trials (Bloomberg)
  • 'Orphan drug' rule raises off-label worries for drugmakers (JDSupra)
  • New MAPP on ANDA Suitability Petitions (FDA)
  • Drug Industry Opposes FDA Recommendation to Review Supplier SOPs (FDA News)
  • Allergan shares rise on push for Restasis trials (Market Watch)
  • OPDP Letters for Promotion of Investigational Compounds (Eye on FDA)
  • J&J Said to Weigh $3 Billion Settlement of Its Hip Implant Cases (Bloomberg)
  • Medtronic pursues PMA for IN.PACT Admiral (BioSpectrum)
  • HeartWare's still chasing PMA, more study results on the way (Mass Device)

In Focus: International

  • Time Is Running Out For Revised EU Clinical Trials Legislation (Pink Sheet)
  • NICE error means breathing room for Lilly's Alimta (SCRIP) (Pharma Letter)
  • Dutch ban Dexaprine fat burner after hospitalisations (Nutra-Ingredients)
  • China Launches Five-Month Crackdown On Illegal Internet Drug Sales (PharmAsia)
  • Bayer gets new Japanese approval for Stivarga (PMLive) (PharmaTimes)
  • GlaxoSmithKline China scandal: British man arrested (The Guardian)
  • A Closer Look: Tips To Survive The Latest China Anti-Bribery Crackdown (PharmAsia)
  • Japan's MHLW approves 367 generics, but what does this mean? (Pharma Letter)

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

US

Pharmaceuticals/Biotechnology
  • Basilea Falls on FDA Request for Two Drug Trials (Bloomberg)
  • 'Orphan drug' rule raises off-label worries for drugmakers (JDSupra)
  • New MAPP on ANDA Suitability Petitions (FDA)
  • Drug Industry Opposes FDA Recommendation to Review Supplier SOPs (FDA News)
  • Allergan shares rise on push for Restasis trials (Market Watch)
  • OPDP Letters for Promotion of Investigational Compounds (Eye on FDA)
  • FDA Approves Banner Pharmacaps' generic Progesterone (#200900) (FDA)
  • FDA Approves NDAs for Hospira's Erythrocin (#050609), Aptalis Pharma's Urso Forte (#020675) and Urso 250 (#020675) (FDA)
  • FDA: Guidance Safety Labeling Changes (Policy and Medicine)
  • FDA Links Foreign Drugs To Life-Threatening Side Effects (Law 360)
  • Drug Shortages Persist in Wake of Surveys (AJMC)
  • Approval Letter - FluLaval (FDA)
Medical Devices
  • J&J Said to Weigh $3 Billion Settlement of Its Hip Implant Cases (Bloomberg)
  • Medtronic pursues PMA for IN.PACT Admiral (BioSpectrum)
  • HeartWare's still chasing PMA, more study results on the way (Mass Device)
  • Boston Scientific eyes FDA with PAD stent (Fierce)
  • Reverse Medical Corporation Announces FDA 510k Clearance of the MVP™ Micro Vascular Plug for Peripheral Embolization (RMC)
Assorted And Government
  • Can Agencies Legally Use Social Media for Rulemaking? (RegBlog)
  • Recalls Of FDA-Regulated Products - What You Need To Know  (Covington)
Upcoming Meetings And Events
  • 19 August 2013: FDA Basics Webinar: Biological Products, Part 2: Biosimilar Biological Products (FDA)
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • 4-5 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Time Is Running Out For Revised EU Clinical Trials Legislation (Pink Sheet)
  • NICE error means breathing room for Lilly's Alimta (SCRIP) (Pharma Letter)
  • Dutch ban Dexaprine fat burner after hospitalisations (Nutra-Ingredients)
  • CTI's Pixuvri wins French reimbursement despite "weak" medical benefit (SCRIP)
  • Novo Nordisk Withholding Tresiba From German HTA Process (Pink Sheet)

Asia

  • China Launches Five-Month Crackdown On Illegal Internet Drug Sales (PharmAsia)
  • Bayer gets new Japanese approval for Stivarga (PMLive) (PharmaTimes)
  • GlaxoSmithKline China scandal: British man arrested (The Guardian)
  • A Closer Look: Tips To Survive The Latest China Anti-Bribery Crackdown (PharmAsia)
  • Japan's MHLW approves 367 generics, but what does this mean? (Pharma Letter)
  • Biocon, Dr. Reddy's, Intas Plan Biosimilars Of Roche's Herceptin (PharmAsia)
  • Eisai Receives Approval To Market Pariet Triple Formulation Packs Rabecure 400 And 800 And Rabefine, For Primary And Secondary H. Pylori Eradication Respectively, In Japan (Eisai)
  • Tensys' TL-300 Receives SFDA Approval for Chinese Market (Tensys)

Other International

  • AllTrials Poised to Launch a Database of Clinical Trials (AT.net)

General Regulatory And Interesting Articles

  • Personalized Medicine Can Lead To Optimized Clinical Trial Design, Improved Selection of Therapeutic Candidates (Eye for Pharma)
  • Patient view: Getting lung cancer patient voices heard in health technology appraisals (SCRIP)
  • RBCC and n3D Market New iPhone App to Dramatically Shorten Drug Toxicity Testing (RBCC/n3D)

Regulatory Reconnaissance #136  - 21 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.


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