Regulatory Focus™ > News Articles > Regulatory Recon: Scope Makers Fujifilm, Hoya and Olympus Warned for Testing and Reporting Issues (1

Regulatory Recon: Scope Makers Fujifilm, Hoya and Olympus Warned for Testing and Reporting Issues (18 August 2015)

Posted 18 August 2015 | By Michael Mezher 

Regulatory Recon: Scope Makers Fujifilm, Hoya and Olympus Warned for Testing and Reporting Issues (18 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

In Focus: International

  • EMA Nearing Executive Director Selection (Pink Sheet-$)
  • EU lays out draft on new obligatory safety features for medicines (In-Pharma Technologist)
  • Doctors warned to curb antibiotic prescribing (OnMedica)
  • Danish Pharma Hopes Stand-alone Medicines Agency Will Speed Up Drug Reviews (Pink Sheet-$
  • India rejects Lee Pharma’s compulsory licence plea (Economic Times)
  • State drug testing labs receive samples for complete testing of spurious drugs (PharmaBiz)
  • USFDA inspects Sharon Bio-Medicine's Dehradun-based plant (Economic Times)
  • Sierra Leone down to the last chain of Ebola virus transmission (WHO)

US: Pharmaceuticals and Biotechnology

  • FDA Puts Science Over Politics In Female Libido Pill Review (Law360-$) (CBS News) (Washington Post)
  • Seattle Genetics Wins 3rd Indication For Adcetris (SCRIP-$) (Press)
  • Biosimilars in rheumatology: current perspectives and lessons learnt (Nature-$)
  • Obesity Drug Labeling Updated with New Interaction, Side Effect (MPR)
  • Tiny Phama Could Benefit From US Anti-Heroin Effort (SCRIP-$)
  • Still no plans to resume manufacturing at former Ben Venue plant (In-Pharma Technologist)
  • Hartley Medical Issues Voluntary Recall of Prolotherapy with Phenol Due to Non-sterility Concerns (FDA)
  • Detecting Deception: USP Screening Methods for Supplements Adulterated with Drugs (USP)
  • Here are some of the complexities of the drug cost debate (MedCityNews)

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

  • La Jolla Pharmaceutical Company Receives Orphan Drug Designation for Two Novel Compounds for Fibrodysplasia Ossificans Progressiva (Press)
  • Esperion Gets FDA Phase III Go-Ahead Without CVOT (SCRIP-$) (BioCentury)
  • FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (Press)
  • Clinical Data From Merz Neurosciences’ Phase III Study of Xeomin® (Incobotulinumtoxina) for Spasticity to Be Published in “Muscle & Nerve” (Press)
  • Remedy Pharmaceuticals Initiates Phase 2A Study of CIRARA™ in Spinal Cord Injury (Press)
  • Atezolizumab shrank tumours in people with NSCLC in PII study (EuropeanPharmaceuticalReview)
  • Pentasa Caps Approved for New Administration Option (MPR)
  • Mesoblast Sees Chance For Faster Phase III Heart Failure Trial (Pink Sheet-$)
  • InSite Vision Announces FDA Acceptance of NDA Filing for BromSite (Press)
  • Lannett Receives FDA Approval, Launches Generic Antidepressant Drug ABILIFY (Press)

US: Pharmaceuticals and Biotechnology: General

  • Providing Submissions in Electronic Format-Postmarketing Safety Reports for Vaccines; Guidance for Industry (FDA)
  • Global Unique Device Identification Database (GUDID): Data Submission Compliance Date September 24, 2015 (FDA)
  • Uncomplicated Gonorrhea: Developing Drugs for Treatment; Guidance for Industry; Availability (FDA)
  • Electronic Study Data Submission; Data Standards; Support for Study Data Tabulation Model Implementation Guide Version 3.2 (FDA)
  • Has Kim Kardashian ruined pharma marketing, too? Fallout from the infamous Instagram post (FiercePharmaMarketing)
  • Using Social Media to Monitor Postmarket Drug Safety (Law360-$)

US: Medical Devices

  • Pilot Program for Medical Device Reporting on Malfunctions (FDA)
  • New FDA Crackdown On Duodenoscope Makers Includes Warning Letters, 510(k) Status Alerts (Gray Sheet-$) (Modern Healthcare) (WSJ-$) (Washington Post) (NBC News) (Reuters)
  • Olympus Took Years To Disclose Infections, FDA Says (Law360-$)
  • JAMA medical device study highlights concerns with 21st Century Cures Act (MedCityNews)
  • Western/Scott Fetzer Company OxyTOTE Portable Oxygen Unit May Ignite and Burst (FDA)
  • Guided Therapeutics Advances LuViva PMA Application with FDA (Press)
  • Minimally Invasive Robotic Surgical Tool Feels for Tumors (medGadget)
  • Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems (FDA)

US: Assorted and Government                                                                                            

  • Sen. Decries FDA's 'Reckless' Approval Of OxyContin For Kids (Law360-$) (The Hill)
  • Judge Orders Actavis to Pull Opana Generic From Market (FDANews-$)
  • Federal judge approves consent decree with Iowa drug and dietary supplement maker, Iowa Select Herbs (FDA)

Upcoming Meetings and Events              

Europe

Canada

Australia

  • Vertical Expandable Prosthetic Titanium Rib caudal rib supports (TGA)

India

  • India rejects Lee Pharma’s compulsory licence plea (Economic Times)
  • Sun's Plant Review Blueprint: Balance and Fall-Backs (SCRIP-$)
  • State drug testing labs receive samples for complete testing of spurious drugs (PharmaBiz)
  • USFDA inspects Sharon Bio-Medicine's Dehradun-based plant (Economic Times)

Ebola Outbreak

  • Sierra Leone down to the last chain of Ebola virus transmission (WHO)

Other International

  • New agency to replace South Africa Medicines Control Council (PharmaLetter-$)
  • Israeli company seeks FDA nod for ear-clip-based glucose monitoring (MobiHealthNews)

General Health and Other Interesting Articles

  • Teaming up (not ganging up) Against Opioid Abuse (DrugWonks)     

Regulatory Reconnaissance #620 – 18 August 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 @Michael_Mezher 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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