Regulatory Focus™ > News Articles > Regulatory Recon: Ranbaxy's Regulatory Problems Cost Consumers Millions (18 June 2014)

Regulatory Recon: Ranbaxy's Regulatory Problems Cost Consumers Millions (18 June 2014)

Posted 18 June 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Ranbaxy's Regulatory Problems Cost Consumers Millions (18 June 2014)

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

In Focus: US

  • Ranbaxy's Regulatory Problems Cost US Consumers Millions of Dollars (Pharmalot) (WSJ-$) (Bloomberg-April 2014)
  • USPTO Sets New Rules On Patent Terms After Novartis Ruling (Law 360-$)
  • The broken antibacterial market (TIE)
  • FDA wants another panel hearing on Boston Scientific's Watchman anti-stroke device (Mass Device) (Grey Sheet-$)
  • FDA panel issues mixed vote on EnteroMedics weight-loss implant (Mass Device) (Gray Sheet-$) (BioCentury)
  • Next Path2Cures Meeting Set, Will Focus on Digital Health (E&C)

In Focus: International

  • EMA: Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies (EMA)
  • Gardasil approved in Europe to prevent anal cancer (Pharma Times)
  • NICE urges greater use of novel anticoagulants (Pharma Times)
  • What GMP Changes can we still expect for 2014? (ECA)
  • Novartis calls in third-party trial reviewer after Japan SAE scandal (In-Pharma)
  • Review of Quality Deficiencies Found in API Master Files at WHO (JPPS)

US: Pharmaceuticals and Biotechnology

  • Ranbaxy's Regulatory Problems Cost US Consumers Millions of Dollars (Pharmalot) (WSJ-$) (Bloomberg-April 2014)
  • USPTO Sets New Rules On Patent Terms After Novartis Ruling (Law 360-$)
  • ISPE Announces Quality Metrics Pilot Launch (Biopharm International)
  • FDA Launches Social Media Landing Page for Industry (FDA)
  • CMM Continuing to Push for MODDERN Cures Act (CMM) (FDA Law Blog)
  • PhRMA "Strongly Supports" 21st Century Cures Initiative (PhRMA)
  • ADA: Merck launches registry for type 2 diabetes (PMLive)
  • Ranbaxy's Gurgaon unit might get to sell drugs in US (Business-Standard)
  • Hospira Announces Voluntary Nationwide Recall of One Lot of 0.5% Marcaine (Bupivacaine HCI Injection, USP), 30 ML, Single-Dose, Preservative-Free Vial Due to Visible Particulates (FDA)
  • Bills Introduced in NY to Regulate Sunscreen Labeling, Opioid Substitution (Sunscreen) (Opioid Substitution)

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

  • Boehringer Ingelheim and Eli Lilly and Company resubmit empagliflozin NDA to FDA (Press) (BioCentury)
  • FDA Accepts NDA For Symplmed Hypertension Drug (AP) (Press)
  • AZ plans to file Onglyza/Forxiga pill by year-end (PMLive)
  • Alkermes Presents Phase 3 Data From Successful Pivotal Study of Aripiprazole Lauroxil for Treatment of Schizophrenia at ASCP Annual Meeting (Press)
  • Analyst: GlaxoSmithKline's Tykerb dead in the water after breast cancer failure (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • The broken antibacterial market (TIE)
  • Executions resume, with help from pharmaceuticals, compounding pharmacies (Philly Pharma)
  • PhRMA Seeks More Time To Submit Sunshine Law's Open Payments Data (IHP-$)

US: Medical Devices

  • FDA wants another panel hearing on Boston Scientific's Watchman anti-stroke device (Mass Device) (Grey Sheet-$)
  • FDA panel issues mixed vote on EnteroMedics weight-loss implant (Mass Device) (Gray Sheet-$) (BioCentury)
  • Device Manufacturers Selling Their Products to the U.S. Government May Soon Be Required to Detect and Report Counterfeit or Nonconforming Items (Inside Medical Devices)
  • Next Path2Cures Meeting Set, Will Focus on Digital Health (E&C)
  • Direct-to-Patient Laboratory Test Reporting: Balancing Access With Effective Clinical Communication  (JAMA)
  • Faster FDA Approval For Medical Devices Coming Soon (Law 360-$)
  • FDA may loosen rules for wheelchair elevators (The Hill) (FDA)
  • When it comes to health products on crowdfunding sites, it's easy to sell fiction about medical devices (The Atlantic)
  • Is Apple "Pushing the Boundaries" of FDA Regulation? (PharmaManufacturing)
  • Lawmakers urge Medicare coverage for cancer test (AP)

US: Dietary Supplements

US: Assorted And Government

  • Thirty Members of Congress Support Eased Medical Marijuana Research (NBC)
  • Who gets an Office at FDA's CDER? (MAPP)

Europe

  • EMA: Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies (EMA)
  • Gardasil approved in Europe to prevent anal cancer (Pharma Times)
  • NICE urges greater use of novel anticoagulants (Pharma Times)
  • NICE guides on antibiotics in pneumonia, OK's Sucampo for constipation (Pharma Times)
  • UK NICE to hold oral appeal hearing for Ferring’s Firmagon (Pharma Letter-$)
  • Scottish Health boards urged to suspend the use of mesh implants (Evening Times)
  • What GMP Changes can we still expect for 2014? (ECA)
  • Czech Republic SUKL updates submission requirements for Centralized Procedure submissions (Exalon)

India

  • Update on the Regulation of Medical Devices in India (Lexology)

Japan & China

  • Novartis calls in third-party trial reviewer after Japan SAE scandal (In-Pharma)

Other International

  • Review of Quality Deficiencies Found in Active Pharmaceutical Ingredient Master Files Submitted to the WHO Prequalification of Medicines Programme (JPPS)

General Regulatory And Interesting Articles

  • How and why Baxter International implemented an automated continued process verification program (Pharma Manufacturing)
  • The Blood Harvest of Horseshoe Crabs (The Atlantic)
  • PatientsLikeMe rolls out clinical trial collaboration tools to help patients work with pharma (MedCityNews)

Regulatory Reconnaissance #339 – 18 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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe