Regulatory Focus™ > News Articles > Regulatory Reconnaissance: GSK Initiates Massive Recall of 'Tampered With' Weight Loss Drug (28 Marc

Regulatory Reconnaissance: GSK Initiates Massive Recall of 'Tampered With' Weight Loss Drug (28 March 2014)

Posted 28 March 2014 | 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.

Do you work in regulatory affairs? Take RAPS' Scope of Practice & Compensation Survey of the Regulatory Profession, a survey of professionals around the world who are involved with the regulatory process for healthcare products. It's the largest, most comprehensive study of the regulatory profession, and helps regulatory professionals benchmark their salary and compensation packages. All survey participants receive a free adanced copy of the report. (More)

In Focus: US

In Focus: International

  • EDQM Out With New Policy on Certificates of Suitability and Requests for Revisions (EDQM)
  • Development of a new Pan-European paediatric formulary initiated to ensure better medicines for children (EDQM)
  • EC Approves Roche's MabThera (Press)
  • ICH Q8-11 Oriented Submission and GMP Expectations for Process Validation and Other Quality Issues Taking Shape in Europe (IPQ-$)
  • India Court Rules Natco CL Of Bayer Drug Does Not Extend To Exports (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • GlaxoSmithKline recalls weight-loss drug Alli (Reuters) (WSJ-$) (AP) (Tan Sheet-$) (Securing Industry) (In Pharma) (Fierce)
  • FDA panel rejects Novartis' heart failure hope serelaxin (PMLive) (Reuters) (MedPage Today) (WSJ-$) (Forbes) (Pink Sheet-$) (SCRIP-$) (Fierce) (BioCentury) (Bloomberg)
  • Trial lawyers helped FDA with rule opening generic drug firms to lawsuits (Washington Examiner)
  • MA to Ban Use of Zohydro (Boston Globe)
  • Upcoming Trade Hearing to Cover FDA Efforts to Regulate Chinese Drugs (US)
  • Some liver concerns, but FDA mostly favorable on Durata's dalbavancin (SCRIP-$)
  • MannKind's Inhaled Diabetes Drug Tied to Lung Function Concerns (Bloomberg) (Reuters)
  • Former Presidential Contender Newt Gingrich Calls for FDA to be Replaced (Gingrich)
  • Despite concerns over imports, US drugs are generally safe (AEI)
  • Opinion: FDA defensiveness is bad for US patients (S4S)
  • FDA Briefing Documents on Afrezza (FDA)
  • FDA Launching New Regulatory Science Fellowship on Alzheimer's Disease (FDA)
  • Chairman to FDA: Painkiller's approval will lead to deaths (The Hill)
  • Minnesota Bill Would Prohibit Sale of Products Containing Triclosan (Scout)
  • FDA Budget: Compounding Increase Paid With Construction Funding, Efficiencies (Pink Sheet-$)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Novartis files ceritinib as data show selectivity bonus (SCRIP-$)
  • Clovis lung cancer drug continues to impress (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • The Dollar Value of an Extra Year of Life (NYTimes)

US: Medical Devices

  • FDA Panel Gives Exact's Colon Cancer Test Ringing Endorsement (Xconomy) (Press) (Reuters) (BioCentury) (Clinica-$)
  • FDA releases DexCom warning letter (Mass Device) (FDA) (Law 360-$)
  • FDA approves William Demant hearing aid against tinnitus (Reuters)
  • NY High Court Lets Biotronik Pursue Recall-Related Damages (Law 360-$)
  • FDA Issues Proposed Rule Amending Classification and Reclassification Regulations for Medical Devices (21 C.F.R. Part 860) (FDA Law Blog)
  • Guided Therapeutics wants a sit-down with FDA (Mass Device)
  • Meridian Bioscience Receives FDA Clearance for New Molecular Amplification Test: illumigene Pertussis (Press)
  • How Sure Can We Be About Optisure? (CardioBrief)

US: Dietary Supplements

  • Companies must walk fine line when bringing a supplement to market in US that is a drug elsewhere (NI-USA)
  • Culture Shock: Homeopathic Recall is No Joke (MedPage Today)

Europe

  • EDQM Out With New Policy on Certificates of Suitability and Requests for Revisions (EDQM)
  • Development of a new Pan-European paediatric formulary initiated to ensure better medicines for children (EDQM)
  • EC Approves Roche's MabThera (Press)
  • ICH Q8-11 Oriented Submission and GMP Expectations for Process Validation and Other Quality Issues Taking Shape in Europe (IPQ-$)
  • The MHRA's new guidance on standalone software as medical device  (MedicalDevicesLegal)
  • Crucial EU compact vote on U.S.-style device approval system raises industry concern (Fierce)
  • Trade talks between US and EU could increase cost of drugs, new report says (BMJ)
  • EMA to review Gilead's HCV combo (BioCentury) (Press)
  • Paediatric penicillin dosing "needs urgent review" (PJO)
  • Why Sanofi, Regeneron's Zaltrap waves a red flag for drug pricing strategies (First Word Pharma)

India

  • India Court Rules Natco CL Of Bayer Drug Does Not Extend To Exports (PharmAsia-$)
  • India Commerce Chief Vows No 'Robin Hood' Use Of Compulsory License" (PharmAsia-$)
  • Japan & China
  • Supervision Of Sterile Products By Risk - China NHFPC Draft (PharmAsia-$)

Other International

  • Australia Warns on Hospira, Medtronic Devices (TGA) (TGA)

General Regulatory And Interesting Articles

  • Retrospective analysis of more than 100 failed drugs show that many should never have made it to clinical trials (Scientific American)
  • Video captures amazing moment deaf British woman hears for the first time (NYDailyNews)
  • Anti-Anxiety Drugs Tied to Higher Mortality (NYTimes)
  • Woman's Native Skull Replaced with 3D Printed Plastic Model (MedGadget)

Regulatory Reconnaissance #286 - 28 March 2014

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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe