Regulatory Focus™ > News Articles > Regulatory Recon: Kim Kardashian Selfie Prompts FDA Warning Letter (12 August 2015)

Regulatory Recon: Kim Kardashian Selfie Prompts FDA Warning Letter (12 August 2015)

Posted 12 August 2015 | By Michael Mezher 

Regulatory Recon: Kim Kardashian Selfie Prompts FDA Warning Letter (12 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

  • GSK closes North Carolina plant after Legionnaires' bacteria found (Reuters)
  • Amarin Off-Label Promotion Decision: A Watched Pot Boils (Law360-$)
  • The Amarin Decision: Free Speech Or Truthiness? (CardioBrief)
  • US FDA Joint Advisory Committee to Weigh in On the Return of Perdue’s Oxycodone IR, But in an Abuse-Deterrent Formulation (Tarius)
  • FDA Warning for Kim Kardashian (FDA Atty) (Law360-$) (MedCityNews) (Eye on FDA) (BuzzFeed)
  • Drug Makers Betting The Farm On Others' Cybersecurity (SCRIP-$)
  • Guidance for Entities Considering Whether To Register as Outsourcing Facilities (FDA)
  • GDUFA Stakeholder Deadline Extended; Are Talks Delayed? (Pink Sheet-$)
  • FDA Review Trends: PMA Approvals On Track For 15-Year High (Gray Sheet-$)
  • Wide-variation found in amount, quality of evidence for high-risk therapeutic medical devices receiving FDA premarket approval (MNT) (Reuters)

In Focus: International

  • Should Off-Label Comparators Be Used In HTAs? Swedish Court Investigates (SCRIP-$)
  • GPvP inspections of contract service providers (MHRA)
  • German inpatient innovation scheme changes ahead (Clinica-$)
  • Barriers to reclassifying drugs identified by researchers (Pharmaceutical Journal)
  • EMA Revising Guidelines on Postauthorization Safety Studies (FDANews-$) (Focus)
  • Delhi government bans over the counter sale of NSAIDS without prescription (Economic Times)
  • A Milestone in Africa: No Polio Cases in a Year (NYTimes)
  • BioPharma Manufacturing in the EMEA Region (Pharmaceutical Manufacturing)

US: Pharmaceuticals and Biotechnology

  • GSK closes North Carolina plant after Legionnaires' bacteria found (Reuters)
  • Amarin Off-Label Promotion Decision: A Watched Pot Boils (Law360-$)
  • The Amarin Decision: Free Speech Or Truthiness? (CardioBrief)
  • US FDA Joint Advisory Committee to Weigh in On the Return of Perdue’s Oxycodone IR, But in an Abuse-Deterrent Formulation (Tarius)
  • First Drug Approved for Primary Periodic Paralysis (MPR)

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

  • Brintellix sNDA Accepted for Labeling Update on Cognitive Effects (MPR)
  • FDA expands use of Orexo's opioid addiction drug (PharmaTimes)
  • Eleven Biotherapeutics Announces First Patients Dosed with EBI-005 in Phase 3 Study (Press)
  • Pivotal Phase II Study of Investigational Medicine Venetoclax Met Primary Endpoint (Press)
  • Neuropore Therapies Commences Phase 1 Clinical Trials (Press)
  • Pivotal Phase II study of investigational medicine venetoclax met primary endpoint in a hard-to-treat type of chronic lymphocytic leukemia (Press)
  • Adynxx meets in pain relief Phase II (BioCentury)
  • Karyopharm Alters Cancer Drug Trial Amid Sepsis Concerns (Pharmaceutical Manufacturing)
  • Research Advances Potential for Test, Vaccine for Genital and Oral Herpes (ICT)
  • AbbVie to seek FDA approval for leukemia drug after trial success (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • FDA Warning for Kim Kardashian (FDA Atty) (Law360-$) (MedCityNews) (Eye on FDA) (BuzzFeed)
  • Drug Makers Betting The Farm On Others' Cybersecurity (SCRIP-$)
  • FDA Releases 2012 and 2013 NARMS Integrated Annual Report; Finds Some Improvement in Antibiotic Resistance Trends in Recent Years (FDA)
  • Guidance for Entities Considering Whether To Register as Outsourcing Facilities (FDA)
  • Frances Oldham Kelsey, Ph.D., M.D.: A Pioneer in Public Health and Protection of Patients (FDA Voice)
  • How to comment on FDA regulations (ECA)
  • FDA Supply Chain Pilots To Be Conducted By Outside Group (Pink Sheet-$)
  • FDA Upgrades Drug Shortage App (Pharmaceutical Processing)
  • Vaccines: FDA Guide Tells You What You Need to Know (FDA)
  • US generic industry preps for GDUFA reauthorisation marathon (In-Pharma Technologist)
  • GDUFA Stakeholder Deadline Extended; Are Talks Delayed? (Pink Sheet-$)

US: Medical Devices

  • FDA Review Trends: PMA Approvals On Track For 15-Year High (Gray Sheet-$)
  • Wide-variation found in amount, quality of evidence for high-risk therapeutic medical devices receiving FDA premarket approval (MNT) (Reuters)
  • After Years of Study, the FDA Endorses Safety Device for Liquid Children’s Medications (ProPublica)
  • FMEA is not ISO 14971 risk management for medical devices (MedCityNews)
  • Device May Detect Urinary Tract Infections Faster (ICT)
  • How Does a Bad Idea Get Implanted? (Drug and Device Law)
  • Study: Device industry suffers from first-mover disadvantage due to FDA regs (FierceMedicalDevices)
  • Cybersecurity Risks with Connected Devices (InsideMedicalDevices)
  • Wearables help manage neurological disorders, predict symptoms (MedCityNews)
  • Splitting Tips Spur Class I Recall For Cook's Beacon Tip Angiographic Catheter (Gray Sheet-$)
  • Study: Edwards’ Sapien and Medtronic’s CoreValve outcomes are similar (MassDevice)
  • FDA clears seven-day platelet storage and wireless capability for the Trima Accel system from Terumo BCT (MNT)
  • Lab-on-a-Disc Device Detects Urinary Tract Infections in About an Hour (medGadget)
  • Google restructuring puts Life Sciences & Calico group under new umbrella (MassDevice)

US: Assorted and Government

  • Forrest Bird, Inventor Of Mechanical Ventilators, Dies At 94 (Gray Sheet-$)
  • House to CMS: Don’t treat biosimilars like generics (BioPharma-Reporter)

Upcoming Meetings and Events              

Europe

  • Should Off-Label Comparators Be Used In HTAs? Swedish Court Investigates (SCRIP-$)
  • GPvP inspections of contract service providers (MHRA)
  • German inpatient innovation scheme changes ahead (Clinica-$)
  • Barriers to reclassifying drugs identified by researchers (Pharmaceutical Journal)
  • EMA Revising Guidelines on Postauthorization Safety Studies (FDANews-$)
  • No hint of added benefit seen for Lundbeck’s Brintellix, says IQWiG (PharmaLetter-$)
  • ABPI supports NICE implementation resource on biosimilar infliximab (ABPI)
  • "QP" for Medical Device Manufacturers: Changes in the second Draft of the Regulation (ECA)

India

  • Delhi government bans over the counter sale of NSAIDS without prescription (Economic Times)
  • India woos Italian bulk drug makers to cut dependency on Chinese APIs (Economic Times)

Other International

General Health and Other Interesting Articles

  • A community-based approach to new antibiotic discovery (Nature)
  • Researchers Construct Atomic Model of an Immature Retrovirus (ICT)
  • The dirty truth of hospital cleaning: thin science (Modern Healthcare)

Regulatory Reconnaissance #616 – 12 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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