Regulatory Focus™ > News Articles > Regulatory Recon: What can Regulators Expect from FDA's Drug Quality Changes? (14 January 2015)

Regulatory Recon: What can Regulators Expect from FDA's Drug Quality Changes? (14 January 2015)

Posted 14 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: What can Regulators Expect from FDA's Drug Quality Changes? (14 January 2015)

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

In Focus: US

  • FDA’s New Pharma Quality Office Will Take a Team Approach: Yu Explains (Pharmalot)
  • Utah Bill Would Give Dying Access To Experimental Drugs (Law 360-$) (AP)
  • FDA Removes over One Thousand Drug Companies from its Database (Registrar Corp)
  • Mylan's REMS lawsuit against Celgene gaining traction (BioPharmaDive)
  • Bard loses bid to delay pelvic mesh cases over judge's comments over judge's comments (Mass Device)
  • 56 GI devices receive FDA 510(k) clearance in 2014 (Beckers)
  • FTC Settlement Silent on the Number of RCTs Required for Supplements (FDA Law Blog)
  • Legislators preview 21st Century Cures bill (BioCentury) (CNN)

In Focus: International

  • Ten years on, EMA completes overhaul of biosimilar guidelines (SCRIP-$)
  • AstraZeneca loses German court appeal over Seroquel XR drug patent (Reuters)
  • Diclofenac tablets now only available with script, says MHRA (Nursing Times) (MHRA)
  • US FDA rejects Pharmexcil claims it no longer lets Indian regulators know about inspections (In-Pharma)
  • Abortion drug decision pushed back by Health Canada (CBC) (Globe and Mail)

US: Pharmaceuticals and Biotechnology

  • FDA’s New Pharma Quality Office Will Take a Team Approach: Yu Explains (Pharmalot)
  • Utah Bill Would Give Dying Access To Experimental Drugs (Law 360-$) (AP)
  • 14% of Drug Facilities Failed to Renew their U.S. FDA Registration (Registrar Corp)
  • FDA Removes over One Thousand Drug Companies from its Database (Registrar Corp)
  • Mylan's REMS lawsuit against Celgene gaining traction (BioPharmaDive)
  • The Limits Of An SPA: Ferring Nocdurna Review Elicits Discussion Of What Trial Agreements Can’t Do (RPM Report-$)
  • FDA Requires Color Batch Certification for High Risk Color Additives (Registrar Corp)
  • Brown's Compounding Center Registers as Outsourcing Facility (Press)
  • Some Abilify Formulations to Discontinue in 2015 (MPR)

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

US: Pharmaceuticals and Biotechnology: General

  • Almost a third of newly approved drugs are cold chain products (PharmaCommerce)
  • Proposed San Mateo County ordinance would require drug companies to pay for disposal program (Examiner)

US: Medical Devices

  • Bard loses bid to delay pelvic mesh cases over judge's comments over judge's comments (Mass Device)
  • 56 GI devices receive FDA 510(k) clearance in 2014 (Beckers)
  • Class 1 Recall for Boston Scientific's Lotus TAVR Aortic Valve (FDA)
  • COPD 3D Tracking Tool Granted 510k Status by FDA (HCPlive)
  • New Analysis Challenges Arguments for Repealing Tax on Medical Devices (NYTimes)

US: Dietary Supplements

  • FTC Settlement Silences Advertisers of Supplements Advertised as Effective for Children’s Speech Disorders; Settlement Silent on the Number of RCTs Required (FDA Law Blog)
  • FDA Import Refusals: Top 5 Labeling Violations (Registrar Corp)

US: Assorted And Government

  • Legislators preview 21st Century Cures bill (BioCentury) (CNN)
  • OpenFDA: Making Federal Public Health Data Sets Accessible (Government Technology)
  • Bill: Make it Easier for the Poor to Participate in Clinical Trials (House)
  • GOP regs bill sails through House (The Hill)
  • Burgess Introduces Bill to Ensure Doctors Have Access to Educational Materials (Press)

Upcoming Meetings

Europe

  • Ten years on, EMA completes overhaul of biosimilar guidelines (SCRIP-$)
  • AstraZeneca loses German court appeal over Seroquel XR drug patent (Reuters)
  • Diclofenac tablets now only available with script, says MHRA (Nursing Times) (MHRA)
  • BioCryst Pharma Receives Positive Opinion From EU For Angiodema Compound BCX4161 (Press)
  • Aveo might seek European approval of kidney cancer drug tivozanib (BizJournal)
  • GSK's Incruse Ellipta gets OK for NHS Wales (PharmaTimes)

India

  • US FDA rejects Pharmexcil claims it no longer lets Indian regulators know about inspections (In-Pharma)
  • State drug regulators tap USFDA coach to polish skills on good manufacturing (India Times)
  • Indian Device Sector has Mixed Reactions to new D&C Bill (PharmaBiz)

Canada

Other International

  • ICH’s Lifecycle Management Initiative Q12 is Targeting the Tough Regulatory Issues, With Patient Supply a Driving Concern; Analytical QbD Also on Expanded ICH Agenda (IPQ)
  • Pre-release of IEC 60601-2-52 1st ed + Amendment 1 – Medical Beds (Eisner Safety)

Clinical Trials

  • What Does Risk-Based Monitoring Mean for QA Auditing? (MasterControl)
  • Oracle to use Proteus' 'digital pills' in its clinical trial management platform (Fierce)

Regulatory Reconnaissance #471 – 14 January 2015

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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