Regulatory Focus™ > News Articles > Regulatory Recon: IMDRF's Medical Device Audit Program Starts to Take Shape (20 January 2015)

Regulatory Recon: IMDRF's Medical Device Audit Program Starts to Take Shape (20 January 2015)

Posted 20 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: IMDRF's Medical Device Audit Program Starts to Take Shape (20 January 2015)

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

In Focus: US

  • IMDRF's MDSAP Pilot Program Starts to Take Shape (FDA)
  • 'Acting' At CDRH: Two Top Offices Are Now Run By Interim Directors (Gray Sheet-$)
  • Tackling Cross-functional Tension during Promotional Reviews (PCM)
  • Re-Inventing FDA's Advisory Committees (BioCentury)
  • GOP finds its secret weapon against regulations: The Congressional Review Act (The Hill)
  • CytRx : FDA Removes Partial Clinical Hold For Aldoxorubicin Trials (RTT) (Press)

In Focus: International

  • MHRA: Wockhardt non-compliance includes all APIs for EU market (In-Pharma)
  • New vice-chair for MHRA's Commission on Human Medicines (Pharmafile) (MHRA)
  • Orphan medicinal products – A European process overview (TOPRA)
  • Health Canada dragging its feet on drug safety: Editorial (The Star)
  • Australia Working to Harmonize its Drug Naming System With the INN (TGA)
  • Nigeria: NAFDAC Opens Door for Online Product Registration (AllAfrica)

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US: Pharmaceuticals and Biotechnology

  • Suit: Stop Law Shielding Lethal Injection Drugmakers' Names (AP)
  • Tackling Cross-functional Tension during Promotional Review and Busting Myths About One Another (PCM)
  • Aurobindo, Actavis Recall Gabapentin Capsules (PTI)
  • Baxter Receives FDA Approval for PHOXILLUM Solution for Electrolyte Management During Continuous Renal Replacement Therapy (Press)
  • Akorn Gets FDA Approval For Phenylephrine HCl Ophthalmic Solution (RTT)
  • CytRx : FDA Removes Partial Clinical Hold For Aldoxorubicin Trials (RTT) (Press)

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

  • Janssen: FDA Grants Priority Review for Three-Month Paliperidone Palmitate for the Treatment of Schizophrenia (Press)
  • Premier Biomedical Files Initial FDA Submission for Fibromyalgia Treatment (Press)
  • Celator Pharmaceuticals Receives FDA Fast Track Designation For CPX-351 For The Treatment Of Elderly Patients With Secondary Acute Myeloid Leukemia (Press)
  • Marathon Pharmaceuticals Receives FDA Fast Track Designation for Deflazacort as a Potential Treatment for Duchenne Muscular Dystrophy (Press)

US: Pharmaceuticals and Biotechnology: General

  • Impact Of 'Me-Too' Drugs On Health Care Costs (Forbes)

US: Medical Devices

  • 'Acting' At CDRH: Two Top Offices Are Now Run By Interim Directors (Gray Sheet-$)
  • The MDSAP: Safeguarding Medical Devices (FDA)
  • 2014 Hot Spots: Top 4 Device Quality & Regulatory Topics (Gray Sheet-$)
  • Bausch + Lomb Introduces New Software and Advanced OCT Imaging System for VICTUS Femtosecond Laser Platform (Press)
  • U.S. Army, Helius Medical Technologies Modify CRADA To Speed PoNS Device Development (Press)

US: Assorted And Government

  • Re-Inventing FDA's Advisory Committees (BioCentury)
  • GOP finds its secret weapon against regulations: The Congressional Review Act (The Hill)
  • Michelle Obama's SOTU Guest is a CF Patient Helped by Kalydeco (White House)
  • FDA Enforcement Report (FDA)

Upcoming Meetings

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Europe

  • Orphan medicinal products – A European process overview (TOPRA)
  • MHRA: Wockhardt non-compliance includes all APIs for EU market (In-Pharma)
  • ABPI: Put value-based assessment back on the agenda (PMLive)
  • Sofosbuvir: a fork in the road for NICE? (AHE Blog)
  • New vice-chair for MHRA's Commission on Human Medicines (Pharmafile) (MHRA)
  • ARIAD Announces Final Decision from European Commission Endorsing Iclusig’s Approved Indications Throughout Europe (Press)

India

  • Karnataka Regulators Warn Industry About Data Integrity Problems (Pharmabiz)

China

  • Novartis Ditches Two Products In China To Focus On New Launches (PharmAsia-$)
  • 13 prescription drugs to be sold OTC in Taiwan (BioSpectrum)
  • CFDA Proposes New Regulations on the Accreditation of Medical Device Trial Sites (Inside Medical Devices)

Canada

  • Health Canada dragging its feet on drug safety: Editorial (The Star)

Australia

  • Australia Working to Harmonize its Drug Naming System With the INN (TGA)

Other International

  • Nigeria: NAFDAC Opens Door for Online Product Registration (AllAfrica)
  • MSF calls on GSK and Pfizer to slash pneumo vaccine price to $5 per child for poor countries ahead of donor meeting (MSF) (Reuters) (PharmaTimes) (Bloomberg)

Regulatory Reconnaissance #475 – 20 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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