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

Regulatory Reconnaissance (5 December 2013)

Posted 05 December 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • US FDA sued for alleged 'unlawful' detention of API batch destined for CMO (In-Pharma) (FDA Law Blog)
  • Jubilant Life Sciences gets warning letter from USFDA (India Times)
  • FTC Releases Agenda for Upcoming Biosimilars Meeting (FTC) (Pink Sheet-$)
  • Tentative Triclosan Monograph Due from FDA on 16 December 2013 (Tan Sheet-$)
  • Intuitive Surgical Warns of Problem With Robot Tool (WSJ-$) (Mass Device) (Fierce)
  • Anne Wojcicki Speaks Out About the F.D.A. Crackdown on 23andMe (NYTimes) (NYTimes)
  • FDA to 2013: Good Riddance (MDDI)

In Focus: International

  • EMA gets important European ruling in AbbVie and InterMune cases (AllTrials)
  • Business as usual for Indian exports under EU falsified meds directive (SCRIP-$)
  • Bureaucracy still weighs heavily in European site selection (Pharma Times)
  • India Said Mulling Compulsory Licenses For Certain Diabetes Drugs (PharmAsia-$)
  • African experts discuss need for better regulation of medicine (Pharma Letter-$)

US: Pharmaceuticals/Biotechnology

  • US FDA sued for alleged 'unlawful' detention of API batch destined for CMO (In-Pharma) (FDA Law Blog)
  • Jubilant Life Sciences gets warning letter from USFDA (India Times)
  • FTC Releases Agenda for Upcoming Biosimilars Meeting (FTC) (Pink Sheet-$)
  • FDA Set To Approve Hepatitis Drug (NPR)
  • Tentative Triclosan Monograph Due from FDA on 16 December 2013 (Tan Sheet-$)
  • FDA Reaches $1.25M Deal Over Mislabeled ASP Products (Law 360-$) (FDA)
  • 3 Biggest FDA Decisions of 2013 (Motley Fool)
  • Half of All Trials Unpublished* (*For certain possibly nonstandard uses of the word "unpublished") (Placebo Control)
  • Can Personalized Medicine And An Adaptive Trial Design Salvage This Hard-Luck Drug? (Forbes)
  • Why Are Cancer Drugs Commonly The Target Of Schemes To Extend Patent Exclusivity? (Health Affairs)
  • Novo Nordisk Lays Out Obesity Commercial Strategy, Ahead of Liraglutide FDA Submission (Pink Sheet-$)
  • US FDA accepts Nova Lab's filing for mercaptopurine in childhood ALL (Pharma Letter-$)
  • FDA Drug Quality and Security Act Stakeholder Discussion Notes (TraceLink)
  • Draft Guidance for Industry: Bioequivalence Recommendations for Paliperidone Palmitate Extended-Release Injectable Suspension (FDA)
  • Dyax Receives Orphan Drug Designation from the U.S. FDA for DX-2930 in Hereditary Angioedema (Press)
  • PhIII Study Gives Support to Biogen's Hemophilia B Drug Alprolix (Press)
  • FDA Gives Immunomedics Lung Cancer Drug Orphan Status (AP)
  • Kinex Pharmaceuticals Announced that the FDA has Granted Orphan Drug Status to KX02 for the Treatment of Gliomas (Press)
  • Consumer Protection Laws And Prescription Meds: A Poor Fit (Law 360-$)
  • Pharmacy Compounding Accreditation Board seeks new executive director (DSN)

US: Pharmaceuticals and Biotechnology: General

  • Drug-Cost Surprises Lurk Inside New Health Plans (WSJ-$)
  • Multiple births linked to fertility drugs on the rise (AP) (NPR)

US: Medical Devices

  • Intuitive Surgical Warns of Problem With Robot Tool (WSJ-$) (Mass Device) (Fierce)
  • Anne Wojcicki Speaks Out About the F.D.A. Crackdown on 23andMe (NYTimes) (NYTimes)
  • FDA to 2013: Good Riddance (MDDI)
  • FDA Clears TYRX Antibacterial Envelope for Use with Spinal Cord Neuromodulators (Press) (Fierce)
  • Ventana receives FDA clearance for Estrogen Receptor (ER) Image Analysis and Digital Read Application for breast cancer (Press)
  • Roche receives FDA clearance to use additional specimen types for chlamydia and gonorrhea test (Press)

US: Dietary Supplements

US: Assorted And Government

  • The Vaccination Effect: 100 Million Cases of Contagious Disease Prevented (NYTimes) (Fierce)
  • White House Report Outlines New Transparency Efforts, FOIA Requests to be Made Easier? (RegBlog)
  • Sunstein: Left and Right Are Both Wrong About Regulation (Bloomberg)

Upcoming Meetings And Events

  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 10-11 December: FTC Meeting on Biosimilars (FTC)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • 11 December 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 11-12 December 2013: Allergenic Products Advisory Committee Meeting (FDA)
  • 12 December 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA gets important European ruling in AbbVie and InterMune cases (AllTrials)
  • Business as usual for Indian exports under EU falsified meds directive (SCRIP-$)
  • Bureaucracy still weighs heavily in European site selection (Pharma Times)
  • GSK's Synflorix receives European marketing authorisation for additional pneumonia indication (Press)
  • EMA Approves Once Every Two Weeks Dosing Option For Hizentra (Human Normal Immunoglobulin, SCIg) (Press) (Pharma Letter-$)
  • New factory puts Iceland in biosimilar drugs race (Reuters)
  • Commission welcomes EU Member States' adoption of Horizon 2020 (EU)

Asia

Other International

  • African experts discuss need for better regulation of medicine (Pharma Letter-$)

General Regulatory And Interesting Articles

  • A rewarding career in regulatory affairs (PJ Online)
  • 'Pharma industry has a deep culture of corruption,' says Thakur (Hindu Business Line)
  • 3-D Printing Will Be a Counterfeiter's Best Friend (Scientific American)
  • Muscle Aches From Statins? Drug Interactions May Play a Role (NYTimes)
  • Ditching Big Drugmakers for Biotech Brings Leukemia Boon (Bloomberg)
  • Does Pharma Only Develop Drugs For Those Who Can Pay? (Forbes)

Regulatory Reconnaissance #215 - 5 December 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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