Regulatory Focus™ > News Articles > Regulatory Reconnaissance: EU Passes New Clinical Trials, Medical Device Rules (3 April 2014)

Regulatory Reconnaissance: EU Passes New Clinical Trials, Medical Device Rules (3 April 2014)

Posted 03 April 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.

In Focus: US

  • FDA cites torn records, unclean toilets for banning Sun Pharma's Gujarat plant (India Times)
  • FDA Begins Implementation of the Drug Supply Chain Security Act: Calls for Comments and a Workshop (FDA Law Blog) (FDA)
  • Toxins in Nutrition Supplements Still Escape FDA Oversight (Scientific American)
  • FDA foreign inspections to rise amid "inventory" build up (SCRIP-$)
  • The FDA 's Focus On Metrics, Performance, And Quality (Life Science Leader)

In Focus: International

  • European Parliament Passes New Medical Device Traceability Rules (EP)
  • Pharmaceutical company AbbVie drops its case against the EMA (AllTrials)
  • EFPIA, ABPI, AllTrials Say They 'Welcome' New Clinical Trials Directive (Pharmafile) (AllTrials)
  • Patient group wants more NICE transparency on rare diseases (BioCentury)
  • Worldwide Medical Device Regulatory Updates (MDS)

US: Pharmaceuticals/Biotechnology

  • FDA cites torn records, unclean toilets for banning Sun Pharma's Gujarat plant (India Times)
  • FDA Begins Implementation of the Drug Supply Chain Security Act: Calls for Comments and a Workshop (FDA Law Blog) (FDA)
  • Woodcock Distances Drug Center, Generic Label Rule From Trial Lawyer Meeting (IHP-$)
  • FDA Is Seeking Ideas for a "New and Improved" Process for Regulating OTC Drugs under the OTC Drug Review (FDA)
  • Wockhardt surges on speculation about early resolution with FDA (LiveMint)
  • Upcoming FDA Meeting to Focus on Bone Health (FDA)
  • Two "Watch Outs" That May Cost Generic Drugmakers Dearly (Lachman)
  • Scientific Program to Support Pharmacoepidemiologic Investigations of Safety Related Issues of Marketed Drugs, and Evaluations of Risk Communications and Management Programs (FDA)
  • FDA's Howard Sklamberg Hits Back at NYTimes Op-Ed (NYTimes)
  • Hikma's Eatontown plant cleared by FDA (SCRIP-$) (In-Pharma) (Fierce)
  • GAO Report on Oversight of Tissue Product Safety (GAO)

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

  • FDA Accepts Biologic License Application for Medicines Co's Fibrocaps Hemostatic Agent (Press)
  • Northwest Bio Warns FDA May Throw Out Phase III Brain Cancer Study (The Street)

US: Pharmaceuticals and Biotechnology: General

  • Alli Recall Could Help Mitigate Reputation Damage In Face Of Tampering (Pink Sheet-$)
  • Virginia Boy Responding To Chimerix Anti-Adenovirus Drug (Forbes)
  • Court halts enforcement of Arizona abortion drug curbs (Reuters)
  • HHS Has Funded Flexible Manufacturing Activities for Medical Countermeasures, but It Is Too Soon to Assess Their Effect (GAO)

US: Medical Devices

  • Covidien CEO Joe Almeida Lays Out To-Do List for New Role as AdvaMed Board Chair (MDDI) (Mass Device) (Gray Sheet-$)
  • Four months later, 23andMe's clash with the FDA remains unresolved (Fierce)
  • Class I Recall for Dräger's Power Supply Unit (FDA)
  • Carestream's New Bone Suppression Software Receives FDA Clearance (Press)

US: Dietary Supplements

  • Diet Supplement Caused Nearly 100 Hepatitis Cases (LiveScience)
  • Toxins in Nutrition Supplements Still Escape FDA Oversight (Scientific American)
  • Hazards of Hindsight - Monitoring the Safety of Nutritional Supplements (NEJM)
  • Dietary Supplement Adverse Event Reports Increase (NPI)
  • Green Coffee Bean Capsule Maker Struggles to Satisfy FDA on GMPs (NPI)

US: Assorted And Government

  • FDA foreign inspections to rise amid "inventory" build up (SCRIP-$)
  • The FDA 's Focus On Metrics, Performance, And Quality (Life Science Leader)
  • FDA, Reagan-Udall Foundation to Hold Annual Meeting in May 2014 (FDA)
  • FDA Weekly Enforcement Report (FDA)

Europe

  • European Parliament Passes New Medical Device Traceability Rules (EP)
  • Pharmaceutical company AbbVie drops its case against the EMA (AllTrials)
  • EFPIA, ABPI Say They 'Welcome' New Clinical Trials Directive (Pharmafile)
  • AllTrials on CTD Reform: Excellent Small Step Forward (AllTrials)
  • France Grants Special Approval to RoActemra for use in Castleman's Disease (ANSM)
  • Patient group wants more NICE transparency on rare diseases (BioCentury)
  • Are You Prepared For The New European Pharmacovigilance Guidelines? (Life Science Leader)
  • EMA accepts Zerenex MAA for review (BioCentury)
  • Astellas Files MAA for Xtandi (Astellas) (Pharma Letter-$)
  • Syneron Sublative Technology Earns CE Mark for Stretch Mark and Acne Scar Treatment (Press)
  • Mobius Imaging Receives CE Mark for Airo Mobile Intraoperative CT  (MedGadget)

India

  • Novartis seeks to block Biocon's Galvus copies in India (SCRIP-$)
  • India Ministries Divided Over CL For BMS Sprycel Blood Cancer Drug (PharmAsia-$)

Japan & China

  • The lowdown on China's medical device regulatory system: how it works (Clinica-$)
  • Novartis Japan staffers shredded and deleted to cover trial misconduct, panel finds (Fierce) (Bloomberg)

Other International

  • Worldwide Medical Device Regulatory Updates (MDS)
  • ANVISA: Regulation must catch up to booming South American supplements market (NI-USA)
  • TGA Strengthens Warnings on Servier's Protos (TGA)

General Regulatory And Interesting Articles

  • Ensuring Compliance With Global Pharmacovigilance Regulatory and Safety Reporting Updates (PCM)
  • Fertility drugs not tied to long term breast cancer risk (Reuters)
  • Body odor changes following vaccination (Press)

Regulatory Reconnaissance #290 - 3 April 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.


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