Regulatory Focus™ > News Articles > Regulatory Recon: The High Costs of Regulatory Noncompliance (19 June 2014)

Regulatory Recon: The High Costs of Regulatory Noncompliance (19 June 2014)

Posted 19 June 2014 | By Alexander Gaffney, RAC

Regulatory Recon: The High Costs of Regulatory Noncompliance (19 June 2014)

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

In Focus: US

  • How Regulatory Fines Hurt Shareholder Returns (Pharmalot)
  • Delaware Puts in Place Emergency Measures to Restrict Zohydro (DE)
  • 2nd FDA hypertension drug recall in 2 months involves 13,000 bottles of generic Toprol (Reuters)
  • DALVANCE Gains Bonus Exclusivity; FDA Grants the First Period of GAIN Act Exclusivity (FDA Law Blog)
  • FDA scrutiny of US unit looms over Wockhardt (LiveMint)
  • FDA warnings about antidepressants may have led to more suicide attempts (WaPo) (NPR) (NBC) (Reuters)
  • FDA Releases Text of Form 483 to Edwards Lifesciences (FDA)

In Focus: International

  • EDQM Publishes Annual Report for the year 2013 (EDQM) (PharmTech)
  • A daunting task for EU firms: update all product info by December (SCRIP-$) (PMLive)
  • Servier Said to Face EU Drug-Delay Fine With Teva Next Month (Bloomberg)
  • AIDCOC expresses concern over CDSCO's move to centralise drug licencing (PharmBiz)

US: Pharmaceuticals and Biotechnology

  • Delaware Puts in Place Emergency Measures to Restrict Zohydro (DE)
  • 2nd FDA hypertension drug recall in 2 months involves 13,000 bottles of generic Toprol (Reuters)
  • DALVANCE Gains Bonus Exclusivity; FDA Grants the First Period of GAIN Act Exclusivity (FDA Law Blog)
  • FDA Looks to Put $2.1 Million More Funding Behind C-Path Initiative (FDA)
  • FDA scrutiny of US unit looms over Wockhardt (LiveMint)
  • FDA warnings about antidepressants may have led to more suicide attempts (WaPo) (NPR) (NBC) (Reuters)
  • The FDA Social Media Guidances May Not Change Anything: Senak Explains (Pharmalot)
  • FDA Has One More Internet Guidance to Publish in 2014: Links (Pharma Marketing Blog)
  • Standards group urges against unique biosimilar names (BioCentury) (IHP-$)
  • Sovaldi And The Case Against Incentives (RPM Report-$)
  • Dose Finding At Breakthrough Speed: FDA Found A Role For Anecdotal Reports OnZykadia (PAM-$)
  • Teva Claims Diovan 180-Day Exclusivity, Arguing Ranbaxy ANDA Was Incomplete (Pink Sheet-$)
  • Forest’s Namenda To Get Label Update After Pediatric Program Failure (Pink Sheet-$)
  • Four Individuals Named Chairs, Co-Chairs of PCORI’s New Advisory Panels on Clinical Trials and Rare Disease (PCORI)
  • Which came first the spaniel or the egg? Novartis' flu vaccine plant OKed (BioPharma Reporter)
  • FDA Talks Antibiotic Resistance (FDA)

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

  • Insmed snags a surprise 'breakthrough' tag for its up-and-down antibiotic (Fierce) (SCRIP-$)
  • FDA places partial hold on OncoMed's Fzd8-Fc (BioCentury) (Press)
  • Takeda Announces Termination of Orteronel (TAK-700) Development for Prostate Cancer in Japan, U.S.A. and Europe (Press) (SCRIP-$)
  • US: Pharmaceuticals and Biotechnology: General
  • Feds Hope To Expand Use Of Addiction Drug (AP)
  • HHS Keeps 340B Orphan Drug Policy Despite Court Ruling (Law 360-$) (BioCentury)

US: Medical Devices

  • FDA Releases Text of Form 483 to Edwards Lifesciences (FDA)
  • FDA Puts Nonabsorbable Expandable Hemostatic Sponges for Temporary use into Class II (FDA)
  • FDA Reclassifies Blade-Form Endosseous Dental Implants as Class II (FDA)
  • Legislators seek ideas to improve digital healthcare landscape (Fierce)
  • What You Need to Know Now About Unique Device Identification (Medical Design)
  • Someday Soon You May Swallow A Computer With Your Pill (NPR)
  • QIAGEN Receives FDA Approval of artus CMV RGQ MDx Kit to Monitor Cytomegalovirus (CMV) Viral Load in Organ Transplant Patients (Press)
  • Standards for sequencing viral genomes in the era of high-throughput sequencing (PubMed)
  • Covidien's Hydrofinity Hydrophilic Guidewire Recalled (FDA) (Mass Device)

US: Dietary Supplements

  • Company Launches New "Medical Food" Intended to Treat IBS (Press)

US: Assorted And Government

  • How Regulatory Fines Hurt Shareholder Returns (Pharmalot)
  • New Office Of Minority Health At FDA: Will it Help Eliminate Disparities In Health? (Health Affairs)
  • House panel seeks to SCRUB onerous regs (The Hill)
  • FDA Enforcement Report - Week of June 18, 2014 (FDA)
  • NIH launches 3D print exchange for researchers, students (NIH)
  • Prioritize When Deposing Plaintiff 'FDA Experts' (Law 360-$)
  • FDAzilla Launches new Form 483 Subscription Service (FDAzilla)

Europe

  • EDQM Publishes Annual Report for the year 2013 (EDQM) (PharmTech)
  • A daunting task for EU firms: update all product info by December (SCRIP-$) (PMLive)
  • Servier Said to Face EU Drug-Delay Fine With Teva Next Month (Bloomberg)
  • It's official: EU reinforces medical device controls through current legal framework (Clinica-$)
  • New drug development for dementia to be fast tracked in UK (OnMedica)
  • UK says Mylan recalls batches of Indian-made antibiotic (Reuters)

India

  • AIDCOC expresses concern over CDSCO's move to centralise drug licencing (PharmBiz)
  • Novartis India Moves On From Glivec Patent Loss To Launch More Drugs (PharmAsia-$)

Other International

  • In absence of regulatory harmonization, regulators share information (SCRIP-$)
  • Tough but reasonable: why it’s worth getting a dialogue going with Singapore regulators (Clinica-$)
  • Counterfeit antibiotics feed drug resistance, superbugs (Fierce)

Clinical Trials

  • Industry shift to risk-based monitoring will change roles of CRAs, experts say (Outsourcing Pharma)
  • Trials involving patients with serious mental illness are poorly reported, researchers find (AllTrials)
  • TransCelerate stops short of offering membership to CROs (Outsourcing Pharma)

General Regulatory And Interesting Articles

  • How the Netherlands Kicked its Animal Antibiotics Habit (Modern Farmer)
  • Antidepressants in pregnancy pose little heart risk for fetus: study (Reuters) (NEJM)
  • False negative results found in prognostic testing for breast cancer (Press)

Regulatory Reconnaissance #340 – 19 June 2014

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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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