Regulatory Focus™ > News Articles > Regulatory Reconnaissance (7 June 2013)

Regulatory Reconnaissance (7 June 2013)

Posted 07 June 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

In Focus: International

  • Comments invited on good-pharmacovigilance-practice module on reporting of adverse reactions (EMA) (Module VI) (Module XVI)
  • Global regulatory trends point to collaborative approach among regulators, industry & academia: Expert (PharmaBiz)
  • Amendments to EMA pharmacovigilance legislation: new notification requirements (Pharma Letter) (FDA News)
  • India's Largest Drug Store Chain Bans Ranbaxy Drugs, Citing Caution (PharmAsia News)
  • Industry: ATMP Reg Lacks Flexibility for Evaluating Non-Drug Components (FDA News)
  • Security in medical devices questioned (IT World Canada)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • Rosiglitazone Restrictions Should Be Eased, FDA Panel Says (MedScape) (GSK) (Forbes) (Forbes) (WSJ) (NYTimes) (Pharma Letter) (SCRIP) (PMLIve) (Med Page Today) (First World Pharma) (Pink Sheet) (PharmaTimes) (BioCentury) (CBS) (Reuters) (NBC) (Law 360) (CNN) (FDA News) (Pharmalot) (Bloomberg)
  • Filthy Pharma: Justice Department Taking "Especially Hard Look" At Manufacturing Plants (Forbes) (Focus)
  • An Experimental Drug's Bitter End Raises Regulatory Questions (NYTimes)
  • Is a Randomized Clinical Trial Appropriate for This Drug to Treat a Pediatric Liver Disease? (NBC)
  • Office of Generic Drugs Provides Picture of New ANDA Stability Requirements (Lachman)
  • FDA OK a Boon to Avanir (DD&D)
  • FDA Approves Claris Lifesciences' ANDA for Levofloxacin (FDA)
  • CorePharma LLC Submits Citizen Petition to Delay Generic Competition (FDA)
  • Amarin Announces it is Preparing for A Vascepa FDA Panel (The Street)
  • Antibiotic Resistance Gets Attention Of FDA, Congress (Pink Sheet)
  • Novartis receives FDA warning (Pharmafile) (SCRIP)
  • Regeneron shares soar on new testing for eye medicine (Market Watch)
  • FDA Citalopram Warning 'Without Merit' (Medscape)
  • Primary Efficacy and Safety Findings from Four Phase 3 Japanese Studies of Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Adult Patients (J&J)
  • Advaxis Requests Orphan Drug Designation for Treatment of Cervical Cancer with ADXS-HPV (Advaxis)
Medical Devices
  • A Snapshot of How (Un)ready the Device Industry is to Implement FDA's Unique Device Identifier (MDDI)
  • CDRH: Compliance Approach May Need More Flexibility (FDA News)
  • Feds: Engineer tried to steal medical device firm's trade secrets (NewsDay)
  • UW Spinout Cardiac Insight Wins FDA OK for Heartbeat Monitor (Xconomy)
  • Symbios Issues Nationwide Recall of all GOPumps Due to High Flow Rates (FDA)
  • St. Jude stands firm despite more Durata scrutiny (Fierce)
  • Complaint-Handling Failures Trigger Warning for Lone Star Medical (FDA News)
  • Intuitive Surgical ships new surgical scissors following crack warning (Mass Device)
  • FDA clears GE Healthcare's Brivo Plus imaging C-arm (Mass Device)
Assorted and Government
  • FDAAA Weakened FDA's Conflict of Interest Regulations, Study Says (MedPage Today) (EurekAlert) (Science Daily)
  • Google accused of profiting from illegal drug sales by state Attorney General (The Verge)
  • Investigator Financial Disclosure Onus Ultimately Rests With Sponsor: Expert (FDA News)
  • Reagan-Udall Foundation seeking nominations for it's Innovation in Medical Evidence Development and Surveillance (IMEDS) program Scientific Advisory Committee (RUF)
  • NIH Backs Consent Process in Preemie SUPPORT Trial (MedPage Today)
  • Presidential Panel Wants to Investigate Genetic and Genomic Testing in DTC Contexts (PCSBI)
  • Dying girl added to adult lung transplant waiting list, boy also sues to be added (CBS) (NBC)
  • Industry groups support regulatory overhaul bill (The Hill)
  • Drug copay rebate cards and coupons (TIE)
  • CardioReady Announces Key Findings from Further Analysis of FDA's Automated External Defibrillator (AED) Data (Business Wire)
Upcoming Meetings and Events
  • 3 June 3013: House Energy and Commerce Committee to Vote on Track and Trace, ADUFA/AGDUFA Bills Bill (E&C) (The Hill)
  • 5-6 June 2013: Two-Day Avandia Meeting (FDA)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

Europe

  • Comments invited on good-pharmacovigilance-practice module on reporting of adverse reactions (EMA) (Module VI) (Module XVI)
  • Amendments to EMA pharmacovigilance legislation: new notification requirements (Pharma Letter) (FDA News)
  • EBS lands CE mark, $3.9M for deep-brain vision loss treatment (Mass Device)
  • Otsuka/Lundbeck's Abilify gets NICE thumbs up for bipolar adolescents (SCRIP) (Pharmafile)
  • Industry: ATMP Reg Lacks Flexibility for Evaluating Non-Drug Components (FDA News)

Asia

  • India's Largest Drug Store Chain Bans Ranbaxy Drugs, Citing Caution (PharmAsia News)
  • Unbearable: Chinese Drugmaker Pulls IPO Over Bear Bile Protests (Pharmalot)
  • Global regulatory trends point to collaborative approach among regulators, industry & academia: Expert (PharmaBiz)
  • Research Fraud at GSK Shanghai? (In the Pipeline)
  • Ranbaxy says it increased focus on, funding for quality since 2010 (India Times)
  • J&J reports Japanese simeprevir data (BioCentury)
  • China Probes Waste, Emissions Violations At Pharma Manufacturing Sites (PharmAsia News)

Other International

  • ISO Issues New Consumer Products Recall Standard (ISO)
  • J&J Issues Hazard Alert in Australia Over its Glenosphere Oreintation Guide (TGA)

General Regulatory and Interesting Articles

  • Security in medical devices questioned (IT World Canada)
  • Despite decade of innovation, much left to do on neglected tropical diseases (IRIN)
  • Contact Lens Computer: Like Google Glass, without the Glasses (MIT)

Regulatory Reconnaissance #83 - 7 June 2013

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.


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