Regulatory Recon: Jail Time for Former Medical Device CEO Over Regulatory Infractions (29 June 2015)

Posted 29 June 2015 By Alexander Gaffney, RAC

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

In Focus: US

  • Former OtisMed CEO Sentenced To Two Years For Selling FDA-Rejected Knee Devices (Gray Sheet-$) (FDA)
  • FDA gives nod to newest pelvic mesh product, despite ongoing safety issues (Fierce)
  • Will Combination Products Join The User Fee Family? (Pink Sheet-$)
  • Not All Devices are Created Equal: UDI Direct Marking (FDA Law Blog)
  • Breakthrough Designation Is A Two-Way Street, FDA Cautions Sponsors (Pink Sheet-$)
  • FDA's Latest ANDA Guidance: Patent Carve Outs Become a Guessing Game (PCM)

In Focus: International

  • EU post-market surveillance and QP role among list of Council's big changes to be mulled (Clinica-$)
  • Pfizer's Fight Against Off-Patent Uses of Pregabalin Comes to Trial Monday (Pharmalot)
  • EC Authorizes Use of Sandoz's Pregabalin for Epilepsy, Neuropathic Pain (EC)
  • Quality check: India's Pharmaceuticals regulator set for revamp (Hindustan Times)
  • Panel submits recommendation on aligning GMP requirements for medical devices in lines with ISO standards (PharmaBiz)
  • Pharmacopoeia Commission mandates pharma cos to submit ADR reports to Pharmacovigilance Programme (PharmaBiz)
  • Update From the Most Recent ICH Meeting (ICH)

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US: Pharmaceuticals and Biotechnology

  • Breakthrough Designation Is A Two-Way Street, FDA Cautions Sponsors (Pink Sheet-$)
  • FDA's Latest ANDA Guidance: Patent Carve Outs Become a Guessing Game (PCM)
  • FDA Engages Internationally to Promote Access to Safe, Effective Animal Medicines (FDA)

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

  • Sarepta Submits DMD Drug for FDA Approval Review (The Street) (Press) (Fierce)
  • BioMarin Announces FDA Accepts Drisapersen NDA for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping (Press)
  • New data fuel hopes for broad use of Novartis psoriasis drug (Reuters)
  • Egalet says drug less likely to be abused than other painkillers (Reuters)
  • Merck Announces Phase 3 Study of Single-Dose EMEND (fosaprepitant dimeglumine) for Injection Regimen Met Primary Endpoint in Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy (Press)

US: Pharmaceuticals and Biotechnology: General

  • ​​3rd Circ. Says Cash Not Key For Pay-For-Delay Suits (Law 360-$) (Ruling) (Law 360-$) (Pharmalot)
  • Merck cancer drugs and Sanofi, Amgen cardio meds have formularies on high alert (Fierce)

US: Medical Devices

  • Former OtisMed CEO Sentenced To Two Years For Selling FDA-Rejected Knee Devices (Gray Sheet-$) (FDA)
  • FDA gives nod to newest pelvic mesh product, despite ongoing safety issues (Fierce)
  • Will Combination Products Join The User Fee Family? (Pink Sheet-$)
  • Not All Devices are Created Equal: UDI Direct Marking (FDA Law Blog)
  • How Many Unique Device Identifiers (UDIs) Will You Need? (Registrar Corp)
  • Therapeutic transdermal drug innovation from 2000 to 2014: current status and outlook (PubMed)

US: Assorted And Government

  • Initial Break-Out of House Ag/FDA Subcommittee FY 16 Appropriation (Strengthen FDA)
  • PwC: This week's regulatory and legislative news (PwC)
  • FDA Weekly Enforcement Report (FDA)

Upcoming Meetings and Events

Europe

  • EU post-market surveillance and QP role among list of Council's big changes to be mulled (Clinica-$)
  • Pfizer's Fight Against Off-Patent Uses of Pregabalin Comes to Trial Monday (Pharmalot)
  • EC Authorizes Use of Sandoz's Pregabalin for Epilepsy, Neuropathic Pain (EC)
  • EC Authorizes Use of Orion Corp's Sileo (Dexmedetomidine HCl) for Acute Anxiety in Dogs (EC)
  • Early access to medicines scheme (EAMS) scientific opinion: Nivolumab (for lung cancer) (MHRA)
  • NICE opens second consultation on diabetes guideline (PharmaTimes)
  • EMA validates Biogen and Sobi's MAA for Alprolix to treat hemophilia B (PBR)

India

  • Quality check: India's Pharmaceuticals regulator set for revamp (Hindustan Times)
  • Panel submits recommendation on aligning GMP requirements for medical devices in lines with ISO standards (PharmaBiz)
  • Pharmacopoeia Commission mandates pharma cos to submit ADR reports to Pharmacovigilance Programme (PharmaBiz)
  • India In A No-Win Situation With Its All India Survey Of Spurious Medicines (Two-Four Insight)
  • Pharma industry's struggles to tighten standards paves way for M&A deals (India Times)

China

  • China Gingko Crackdown Reveals Broad Quality Problems (PharmaAsia-$)

Japan

  • Japan OKs new indication for Bayer's Eylea (PharmaTimes)

Canada

  • Guidance Document - Submission of Risk Management Plans and Follow-up Commitments (Health Canada)

Australia

  • Regulatory compliance for IVD medical devices (TGA)
  • Australia's Ley hits back at drug firms on access to new medicines, reimbursement policies (Fierce)

Other International

  • Update From the Most Recent ICH Meeting (ICH)
  • Marshal your PROs for market access (SCRIP-$)

General Regulatory And Interesting Articles

  • Why Gene-Editing Technology Has Scientists Excited (WSJ-$)

Regulatory Reconnaissance #585 – 29 June 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.

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