Regulatory Focus™ > News Articles > Regulatory Recon: Sunshine Act Day in America; FDA Releases New Device Quality Data (30 September 20

Regulatory Recon: Sunshine Act Day in America FDA Releases New Device Quality Data (30 September 2014)

Posted 30 September 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Sunshine Act Day in America FDA Releases New Device Quality Data (30 September 2014)

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

In Focus: US

In Focus: International

  • EU Device Reform Updates: Setting For Next Round Of Talks Takes Shape (Gray Sheet-$)
  • EFPIA "did not lobby" for EC medicines move (SCRIP-$)
  • Indian Device Industry raises concerns over new notification and labeling rules (PharmaBiz)
  • India's Modi must resist U.S. pressure on drug patents: MSF (Reuters)
  • Canada Wants to get Tough on Pay-to-Delay Deals (WSJ)
  • ICH Q12 to Foster Post-Approval Change Management (Gold Sheet-$)
  • The Post-Approval Challenge of Global Regulatory Complexity (Gold Sheet-$)

US: Pharmaceuticals and Biotechnology

  • FDA says no to anti-addiction rule on Ritalin, painkillers (In-Pharma)
  • Congress might move on compassionate access; wholesale reform looks unlikely (BioCentury-$)
  • Eric Colman, FDA’s Lead Obesity Drug Reviewer, Dies At Age 53 (Pink Sheet-$)
  • Hamburg on Combating Opioid Abuse (USA Today)
  • CDER Reviewers Want Patient-Reported Outcomes Earlier In Drug Development (Pink Sheet-$)
  • Generic Exclusivity? Who Cares! Industry Offers Few Opinions On Potential Changes (Pink Sheet-$)
  • Disease-Awareness Ads Thrive In Regulatory No-Man’s Land (Pink Sheet-$)
  • FDA's Jean-ah Kang Says Google Black Box Ad Format is OK. But Is It "Patient-Centric?" (Pharma Marketing Blog)
  • FDA approves expanded use of Salix Pharma's constipation drug (Reuters) (RTT)
  • FDA Approves RELISTOR Subcutaneous Injection for the Treatment of Opioid-Induced Constipation in Patients with Chronic Non-cancer Pain (Press)
  • Patient-Focused Drug Development High On Industry’s List Of PDUFA VI Tweaks (Pink Sheet-$)
  • Industry’s ‘Regulatory Commitments’ Concept Draws FDA’s Interest (Gold Sheet-$)
  • Bleeding disorder patients tell FDA where they want drug therapies to improve (BioCentury-$)
  • Generic User Fees: Small Firms Might Get Waivers; CMOs Want Them Too (Pink Sheet-$)
  • Advocates want Pediatric Research Equity Act to boost cancer treatments (BioCentury-$)
  • Correcting Misinformation: Eliminate the "Influence Prong," Says Pharma Industry (Pharma Marketing Blog)
  • Groups Say GMPs for Compounding Pharmacies are Unworkable (Gold Sheet-$)
  • “Wildcard Exclusivity” Returns: PCAST Recommends Consideration of a Tradable Voucher to Reward Successful Antibiotic Development (FDA Law Blog)
  • Animal production sees challenges with new antibiotic regulations (CattleNetwork)
  • AAN Warns Against Opioids in Chronic Noncancer Pain (MedPage Today)
  • U.S. FDA Approves Dual-Chamber Syringe for Abilify Maintena (aripiprazole) Extended-Release Injectable Suspension for the Treatment of Schizophrenia (Press)
  • Characteristics of study design and elements that may contribute to the success of electronic safety monitoring systems (PubMed)
  • FDA Petitioned to Make Thiotepa for Injection ANDA the RLD (FDA)
  • FDA responds to NRAA's request to consider allowing import of PD solutions (Nephrology)
  • The Drug Shortage Ecosystem (Drug Wonks)
  • Legislation Calls for FDA Review of Naloxone to Determine OTC Status (Scout)
  • Is Your Pharmacy Compliant with the FDA’s New Rules on Interstate Shipment of Compounded Drugs? (PCM)
  • FDA Approves Revised Indication for Allergan's Ozurdex for Diabetic Macular Edema (Press)

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

  • AstraZeneca sticks to H2 2015 timetable for new lung cancer pill (Reuters) (SCRIP-$)
  • Should Endocyte abandon a cancer drug that works? (IBJ)
  • Avedro Announces Resubmission of New Drug Application to FDA for Corneal Cross-Linking (Press)
  • Phase 3 Results for GSK’s Tafinlar in Mutant Metastatic Melanoma (MPR) (Pharma Letter-$) (Pink Sheet-$)
  • Catalyst Requests Pre-NDA Meeting With FDA (Fierce) (SCRIP-$) (The Street) (BioCentury)
  • Sanofi-Regeneron drug has positive trial results in chronic sinusitis (Reuters)
  • Nivolumab shows signs of superior response rate compared to standard chemo in advanced melanoma (Press)
  • Phase Iii Trial Of Aricept  In Patients With Severe Alzheimer's Disease In China Meets Primary Endpoint (Eisai)

US: Pharmaceuticals and Biotechnology: General

  • Launch Day for Federal Sunshine Act Database (ProPublica) (Policy and Medicine) (Bloomberg)
  • Antibiotic Drug Push By Administration Could Include BARDA Incubator (Pink Sheet-$)
  • HHS Funds Drug to Treat Severe Infections and Prevent Cytokine Storm (PharmPro)
  • BARDA backs Atox drug to combat flesh eating bacteria  (SCRIP-$) (GEN)
  • Drugmakers Boost Generic Drug Prices (Kaiser)
  • High Prices for Orphan Drug can be Sustained, a Payer Survey Shows (Pharmalot)
  • KV Pharmaceutical—Now Known as Lumara—Being Bought by AMAG Pharma (SCRIP-$) (BioCentury)

US: Medical Devices

  • FDA Releases 2013 Quality System Data (Silver Sheet-$) (FDA) (Mass Device)
  • Studies criticize U.S. medical device approval process (Reuters) (HealthDay) (WSJ-$) (Gray Sheet-$) (Gray Sheet-$) (Press) (Mass Device) (Philly) (Fierce) (PubMed) (PubMed)
  • FDA Device and Drug Chiefs Push Informed, Robust Patient Engagement (IHP-$)
  • Pressure Builds On FDA To Overhaul Guidance Process (Law 360-$)
  • FDA, NH-ISAC to share medical device cybersecurity tips, risks (HealthITSecurity)
  • Unique device identifiers for coronary stent postmarket surveillance and research: A report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier Demonstration (PubMed)
  • HeartFlow Expects FDA Go-Ahead For Imaging-Based FFR Software Any Day Now (Gray Sheet-$)
  • American Heart Association: Pay More Attention to Radiation in Imaging Procedures (Forbes)
  • Intuitive Surgical wins FDA nod for new robotic 'wrist' (Mass Device) (Press)
  • AliveCor launches new app with FDA-cleared AFib algorithm (MobiHealth news)
  • FDA Clears Next-Generation SURGIMAP 2.0 Software, First Pre-Operative Planning Platform for Personalized Spinal Implants (Press)
  • Luminex Receives FDA Clearance To Add New Clinical Targets And Additional Sample Type For Use With xTAG Gastrointestinal Pathogen Panel (Press)

US: Dietary Supplements

  • Caffeinated Underwear? FTC Says It Lacks Buzz (NBC) (Reuters)
  • What’s That Plant You’re Eating? Using DNA Methods as a Solution to Botanicals Quality (QM)

Upcoming Meetings

Europe

  • EU Device Reform Updates: Setting For Next Round Of Talks Takes Shape (Gray Sheet-$)
  • EFPIA "did not lobby" for EC medicines move (SCRIP-$)
  • BMS’s Opdivo approved in Europe for lung cancer (PharmaPhorum) (Press)
  • EDQM Turns 50 (Press)
  • EFPIA and Rx&D Welcome Announcement Indicating Finalisation of CETA Text as a Step to Benefit Patients and Innovation in Future (Press)
  • CVRx wins heart failure CE Mark for Barostim Neo neurostim device (Mass Device) (MedGadget)
  • Occlutech Obtains European CE Approval for its Dedicated Paravalvular Leak Closure Device (Press)
  • Jacked Power' pre-workout supplement under investigation following woman’s brain haemorrhage (Nutra Ingredients)

India

  • Indian Device Industry raises concerns over new notification and labeling rules (PharmaBiz)
  • India's Modi must resist U.S. pressure on drug patents: MSF (Reuters)
  • Court Nixes BMS Block Of Mylan’s Venezuela Atazanavir Exports (PharmAsia-$)
  • Government, pharma industry form 'India-Responsible Healthcare Trust' (India Times)
  • CDSCO Amends Medical Device Regulation In India (TwoFour Insight)

China

  • BSD Medical’s China Distributor Receives China Food and Drug Administration Marketing and Import License Approval for the BSD-2000 Hyperthermia System (Press)

Japan

  • Gilead files single-pill HCV therapy in Japan (SCRIP-$)
  • Japan approves Infraredx's intravascular ultrasound Dx imaging device (Fierce)
  • Japan approves pegfilgrastim for neutropenia (BioCentury)

Canada

  • Canada Wants to get Tough on Pay-to-Delay Deals (WSJ)

Australia

  • TGA Upgrades Payment Portal (TGA)

Other International

  • ICH Q12 to Foster Post-Approval Change Management (Gold Sheet-$)
  • The Post-Approval Challenge of Global Regulatory Complexity (Gold Sheet-$)
  • ICH endorses new Working Groups on Clinical Trials (ECA)
  • Israeli circumcision device provokes union outcry in South Africa (Reuters)

Clinical Trials

  • A test for reporting bias in trial networks: simulation and case studies (PubMed)

General Regulatory and Interesting Articles

  • Drones to deliver drugs to remote German pharmacy (PharmJournal)
  • Antibiotics in infancy may be linked to childhood obesity: study (Reuters)

Regulatory Reconnaissance #410 – 30 September 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.

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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