Regulatory Focus™ > News Articles > Regulatory Reconnaissance (23 April 2013)

Regulatory Reconnaissance (23 April 2013)

Posted 23 April 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance.

In Focus: US

  • States Take Drug Makers to Court Over Marketing (WSJ)
  • FDA Cracking Down On Compounders At Historic Pace (Law 360) ($)
  • FDA Panel Explores Workings of Global TAVR Device Registry (Cardiovascular Business)
  • ASCO Seeking Input on 'Clinically Meaningful' OS (BioCentury)
  • DePuy aims to reverse $8.3M metal hip implant loss (Mass Device)

In Focus: International

  • WHO Issues Supplementary Guidelines on GMP on Sterile Process Validation (PharmaBiz)
  • China FDA Urges Speeded Review Of Drugs, Devices For Quake Relief (PharmAsia News) ($)
  • New Zealand Launches Clinical Trials Portal (Pharma Times)
  • Pip Implants Founder Remains Defiant during Trial (Medtech Insider)
  • South Africa seeks to close drug patent loophole (Med City News)


  • States Take Drug Makers to Court Over Marketing (WSJ)
  • The FDA, Surrogate Endpoints, And Blood Pressure Drugs (Forbes)
  • Janet Woodcock on What Constitutes a Breakthrough Therapy (BioCentury)
  • FDA Cracking Down On Compounders At Historic Pace (Law 360) ($)
  • Warner Chilcott, PLC Announces FDA Approval of New Oral Contraceptive (BioSpace)
  • FDA Approves ANDA for Macleods Pharmaceuticals' Valsartan and Hydrochloririthiazide (FDA)
  • FDA Grants Tentative Approval to Kremers Urban Pharmaceuticals Rabeprazole Sodium (FDA)
  • FDA Grants Labeling Changes for Reclast, Boniva, Ambien, Fosamax, Mycamine, Aciphex, Actonel (FDA)
  • FDA Announces Data Quality Webinar Related to 2008 ADUFA Reauthorization (FDA)
  • Office of Prescription Drug Promotion (OPDP) Launches (FDA)
  • AbbVie hepatitis C drugs knock out virus at eight weeks (Reuters)
  • Bristol-Myers oral hepatitis C regimen looks competitive: study (Reuters)
  • Boehringer Ingelheim announces results from one of its HCV Phase III trials: Investigational compound faldaprevir shows high viral cure and early treatment success in treatment-naïve patients with genotype-1 hepatitis C (Business Wire)
  • Data from Phase 3 Studies of Gilead's Sofosbuvir for Hepatitis C (Business Wire)
  • Pharmaxis Results Of U.S. FDA-Ordered Bronchitol Trial To Be Announced (PharmAsia News) ($)
  • Amarin's Fish Oil Pill Faces Even More Exclusivity Risks (The Street)
  • ViroPharma's VP20621 meets C. difficile endpoint (BioCentury)
Medical Devices
  • Legal: DePuy aims to reverse $8.3M metal hip implant loss (Mass Device)
  • FDA Clearance for Microline Flexible Ligating Shears for SPIDER Laparoscopy Platform (MedGadget)
  • MedShape Eclipse Soft Tissue to Bone Anchor Cleared in U.S. (MedGadget)
  • DFINE STAR Tumor Ablation System Demonstrates Significant Clinical Benefit for Spinal Metastases (MedGadget)
  • Aspect Imaging Receives FDA Clearance of M2 Compact Wrist MRI System (MedGadget)
  • Medtronic Heart Valve Claim Survives Preemption Of Manufacturing Defect Claim (Lexis Nexis) ($)
  • BAROnova's anti-obesity device aces early trial (Fierce Medical Devices)
  • Updated: Medical Device Epidemiology Network Initiative (MDEpiNet) (FDA)
  • Mirena IUD Migrations And Perforations Requiring Surgical Removals Result In Growing Number Of Lawsuits Against Bayer (Drug Injury Watch)
  • FDA Panel explores workings of global TAVR registry (Cardiovascular Business)
  • ASCO seeking input on 'clinically meaningful' OS (BioCentury)
  • National study: Teen misuse and abuse of prescription drugs up 33 percent since 2008 (EurekAlert) (AP) (CBS)
  • 40 percent of parents give young kids medicine they shouldn't (UPI)
  • Biotech Execs Aren't Ready to Prove Drugs Have Value, E&Y Says (Xconomy)
  • Q&A: BIO's Jim Greenwood (MM&M)
  • America is #1 in overall biotech innovation, but policy and stability is the big weak spot (Med City News)
  • BIND-ing with Big Pharma: Cambridge nanoparticle biotech signs 3 deals (Boston Herald)
  • Supreme Court rejects challenge to tobacco warnings (The Hill)
  • FDA Breaks Food Safety Law With Rule Delays, Judge Finds (Bloomberg)
Upcoming Meetings and Events
  • 22 April 2013: Public Meeting - International Consortium of Cardiovascular Registries (FDA)
  • 23 April 2013: FDA Webinar: Home Use of Diabetes and Cardiovascular Medical Devices (FDA)
  • 23 April 2013: Margaret Hamburg to Keynote FDLI's Conference (FDLI)
  • 23 April 2013: FDA Listening Meeting on Use of Antibiotics in Animals in Olympia, WA (FDA)
  • 25 April 2013: Securing Our Nation's Prescription Drug Supply Chain (Energy and Commerce Committee)
  • 25-26 April 2013: Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 25-26 April 2013: Drug Development for Myalgic Encephalomyelitis and Chronic Fatigue Syndrome (ME and CFS) (FDA)
  • 26 April 2013: Senate Appropriations Committee to Markup FDA Bill (Appropriations)
  • 26 April 2013: Does HIPAA Help or Hinder Patient Care and Public Safety? (Energy and Commerce Committee)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (Eye on FDA) (FDA)


  • WHO issues supplementary guidelines on GMP on sterile process validation (PharmaBiz)
  • Upcoming ENVI Meeting on New Medical Device Proposals for the EU (ENVI)
  • China FDA Urges Speeded Review Of Drugs, Devices For Quake Relief (PharmAsia News) ($)
  • New Zealand launches Clinical Trials Portal (Pharma Times)
  • EMA comments on stem cell therapy treatment (EMA)
  • Pip Implants Founder Remains Defiant during Trial (Medtech Insider)
  • Indonesia's State-Owned Kimia Farma Gears Up To Produce Antiretrovirals Under Compulsory License (PharmAsia News) ($)
  • South Africa seeks to close drug patent loophole (Med City News)
  • More than 200 ethics committees got registered with India's DCGI after making it mandatory (PharmaBiz)
  • EC's John Dalli Says Sleep Drugs Don't Raise Concerns With EMA Regarding Death (EurLex)
  • EC says biosimilars increasing competition (BioCentury)
  • Turkey Proposes Helping Local Pharmas To Become Drug Exporters (PharmAsia News) ($)
  • NICE recommends extending blood clot indication of Bayer's Xarelto (PMLive)
  • Over £500,000 of unlicensed sex, diet and hair loss drugs seized in a west London raid (MHRA)
  • Canada-wide Vioxx settlement approved (Canada Newswire)

General Regulatory and Interesting Articles

  • Biotechnology Draws Record Profit as Research Money Slows (Bloomberg)
  • Nashville child born without bones saved by experimental drug therapy (The Tennessean)
  • Edible Batteries Could Power Medical Devices (MDDI)
  • New Implant Brings High Hopes for Back Pain Relief (Scientific American)
  • 9 Materials That Will Change the Future of Manufacturing (Scientific American)

Regulatory Reconnaissance #51 - 23 April 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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.