Regulatory Focus™ > News Articles > Regulatory Reconnaissance (5 September 2013)

Regulatory Reconnaissance (5 September 2013)

Posted 05 September 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

In Focus: US

In Focus: International

  • India may join PIC/S to safeguard drug exports (India Times) (BioSpectrum)
  • India's Export/Import Bacnk Offering Financing to Companies to Help Them Become Compliant with FDA Regulations (Pharmabiz)
  • China talks about 'astronomical' fines against GSK (Fierce) (BioSpectrum)
  • PATH defends itself against Indian criticisms of HPV clinical trials (Fierce)
  • EU's CHMP Decides to Wait on ICH for Metal Impurities Guideline (In-Pharma)
  • NICE VS. Not-So-NICE: A Squabble Over Reimbursement In The UK (Pharmalot)

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

US

Pharmaceuticals/Biotechnology
  • In big setback, GlaxoSmithKline's cancer immunotherapy MAGE-A3 flunks PhIII goal (Fierce) (Reuters) (Pharma Times) (RTT) (GSK)
  • HHS' Adverse Drug Event Action Plan Calls For New Treatment Guidelines (Pink Sheet) (Federal Register)
  • At key Actos trial, lawyer claims Takeda kept cancer risks under wraps (Fierce)
  • FDA Urged To Block Unapproved Post-Surgery Injections (Law 360) (Citizen Petition)
  • FDA to discuss ALK-Abello's grass allergy tablet (BioCentury) (FDA)
  • FDA delays Northera PDUFA by just over a month (BioCentury) (SCRIP)
  • Takeda's vedolizumab wins FDA priority review in colitis, but standard for Crohn's (SCRIP) (Takeda)
  • Can Antitrust Laws Prevent Abuse Of FDA REMS Programs? (Law 360)
  • PhRMA Backs Increased FDA Drug Import Controls (Law 360) (PhRMA)
  • Rockwell Medical's iron deficiency drug succeeds in final study (Reuters) (BioCentury) (SCRIP) (DD&D)
  • FDA Accepts Endo's Complete Response Submission to New Drug Application for AVEED (Testosterone Undecanoate) Injection (Endo)
  • Will Social Media Make it Harder for Pharma to "Hide" Drug Side Effects? (Pharma Marketing)
  • Isis rises on positive triglyceride drug data (PMLive)
  • FDA MAPP: Requesting and Accepting Non-Archivable Electronic Materials for CDER Applications (FDA)
  • FDA MAPP: CDER Full-Time Equivalent (FTE) Ceiling and Onboard Tracking and Reporting  (FDA)
  • J&J Probed By Mississippi AG Over Talcum Powder Promotions (Pharmalot)
  • A Decade Later, Pfizer And Peter Rost Settle Their Dispute (Pharmalot)
  • Patent ruling on Lilly's Alimta lung-cancer drug expected in 2014 (Reuters)
  • Elcelyx's delayed-release metformin meets in Phase IIb (BioCentury)
  • Transgene falls on Pexa-Vec miss in second-line HCC (BioCentury)
  • Actavis Ducks Endo's Opana False Ad Suit In NJ (Law 360)
  • Ariad up on chance it could seek front-line approval next year (BioFlash)
Pharmaceuticals and Biotechnology: General
Medical Devices
  • Siemens recalls microbiology testing panels (Reuters) (FDA) (FDA) (Fierce) (Medscape)
  • Injuries Linked to Da Vinci Surgeries Underreported, Researchers Say (Health Leaders Media) (Mass Device)
  • Michigan Legislators to FDA: Adopt Mobile Medical App Guidance Already! (Scout)
  • Abyrx Receives FDA 510(k) Clearance for New Resorbable Hemostatic Bone Putty (Hemasorb Plus) (Abyrx)
Assorted And Government
  • FDA Updates Code of Federal Regulations With Corrected Definition of the Term "Package" (FDA)
  • Website claims, cGMP violations, and label claims: FDA warning letter round-up for supplements (Nutra Ingredients)
  • 'Watchdog Employees' Can Claim Retaliatory Firing: NJ Court (Law 360)
Upcoming Meetings And Events
  • 2-5 September 2013: Pharmacovigilance Risk Assessment Committee (EMA)
  • 5-6 September 2013: Public Workshop on the Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Fatty Liver Disease (FDA)
  • 5 September 2013: ENVI Meeting on Medicines and Innovation (ENVI)
  • 6 September 2013: EMA Meeting on Best Expertise vs. Conflicts of Interest (EMA) (Agenda)
  • 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (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

  • EU's CHMP Decides to Wait on ICH for Metal Impurities Guideline (In-Pharma)
  • NICE VS. Not-So-NICE: A Squabble Over Reimbursement In The UK (Pharmalot)
  • An end to need for systematic updates of EU risk management plans (Clinica)
  • MHRA Seeks Feedback on Specific Subset of Parallel Import Licenses (MHRA)
  • Bayer's Regorafenib Submitted for EMA for the Treatment of Gastrointestinal Stromal Tumors (Bayer) (Pharma Letter)
  • iSonea asthma monitor AirSonea gets CE mark  (BioSpectrum)

Asia

  • India may join PIC/S to safeguard drug exports (India Times) (BioSpectrum)
  • India's Export/Import Bacnk Offering Financing to Companies to Help Them Become Compliant with FDA Regulations (Pharmabiz)
  • China talks about 'astronomical' fines against GSK (Fierce) (BioSpectrum)
  • PATH defends itself against Indian criticisms of HPV clinical trials (Fierce)
  • China probes against foreign pharma unfair: EU business lobby (Reuters)
  • Three Ways To Understand GSK's China Scandal (Forbes)
  • Chr Hansen: While EU supplement regulations are tough, Asia's are a minefield (Nutra Ingredients)

Other International

  • Industry trials should be better tailored to emerging markets (Pharma Times)

General Regulatory And Interesting Articles

  • Researchers create tool to predict kidney failure or death after injury (MNT)
  • Bioequivalence study designs for generic solid oral anticancer drug products - scientific and regulatory considerations (J. Clinical Pharmacology)
  • The Randomized Registry Trial - The Next Disruptive Technology in Clinical Research? (NEJM)
  • Eli Lilly's Alimta gains may cause Princeton pain (Fierce)
  • Scientific reproducibility is hampered by a lack of specificity of the material resources (EurekAlert)

Regulatory Reconnaissance #146  - 5 September 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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