Regulatory Focus™ > News Articles > Regulatory Reconnaissance (27 November 2013)

Regulatory Reconnaissance (27 November 2013)

Posted 27 November 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • Novartis Petition: Require Biosimilars to Have Same INN as Reference Product (Petition)
  • FDA Denies Petition Requesting GDUFA Fee Payment Changes (Pink Sheet-$)
  • 2014 FDA Drug Approval Decision Calendar (The Street)
  • FDA Proposes New Eye-Tracking Study on DTC TV Advertisements, Effects of Distractions (FDA)
  • FDA Approves Merck's Noxafil (posaconazole) Delayed-Release Tablets (Press) (DD&D)
  • Analysis: 103 FDA regulated mobile medical apps (MobiHealthNews)
  • AHRQ: no evidence of clinical utility for genetic cancer tests (BioCentury)

In Focus: International

  • IMDRF Releases New IVD Table of Contents Guidance (IMDRF)
  • Early dialogue with the EMA is key to success, Regulators Say (EMA) (Pharma Letter-$)
  • Urgency over clinical trials and medtech laws leaves P&R transparency out in the cold (SCRIP-$)
  • Sativex approved for MS in Switzerland (Pharma Letter-$)
  • Wockhardt's Chikalthana plant hit by USFDA import restrictions (India Times) (FT-$) (Bloomberg)
  • Indian Government mulls stricter norms for patents in pharma space (India Times)

US: Pharmaceuticals/Biotechnology

  • Novartis Petition: Require Biosimilars to Have Same INN as Reference Product (Petition)
  • FDA Denies Petition Requesting GDUFA Fee Payment Changes (Pink Sheet-$)
  • 2014 FDA Drug Approval Decision Calendar (The Street)
  • FDA Approves Merck's Noxafil (posaconazole) Delayed-Release Tablets (Press) (DD&D)
  • FDA Proposes New Eye-Tracking Study on DTC TV Advertisements, Effects of Distractions (FDA)
  • Teva Announces Additional Regulatory Exclusivity for Treanda (Bendamustine HCI) for Injection (Press)
  • Priority Review for Durata's dalbavancin (BioCentury) (SCRIP-$)
  • CMC Contrast Granted Orphan Drug Designation by the FDA for its Liver Specific MRI Contrast Media CMC-001 (Press)
  • FDA accepts Purdue Pharma's application for Targiniq (DSN)
  • New Birth Control Label Counters Lawsuit Claim (NYTimes)
  • Op-Ed: Let's Modernize Post-Approval Regulation of Prescription Drugs (PharmExec)
  • FDA-Funded Study Reveals Vaccine Weakness (Forbes)
  • FDA Updates Breakthrough Product Designation page (FDA)
  • Same Song, Different Audience: Pharmaceutical Promotion Targeting Non-Physician Health Care Providers (PLoS)
  • Nature's Pharmacy and Compounding Center Issues Voluntary Recall of All Sterile Compounded Products Distributed Within North Carolina Due to Lack of Sterility Assurance (FDA)
  • GE Healthcare Receives Approval for Its Own Manufacturing of Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) (Press)
  • Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Reopening of the Comment Period (FDA)
  • FDA Law Blog,  Drug & Device Law Chosen to Prestigious ABA Journal Blawg List (FDA Law Blog) (Drug and Device Law)
  • Travelers Says Claims Not Time-Barred In $47M Pfizer Suit (Law 360-$)

US: Pharmaceuticals and Biotechnology: General

  • CMS: ObamaCare has saved seniors $8.9 billion in drug costs (The Hill) (Bloomberg)
  • Pharma Compliance Officers Fret Over Sunshine Act Costs, Data Analytics (Pink Sheet-$)

US: Medical Devices

  • Analysis: 103 FDA regulated mobile medical apps (MobiHealthNews)
  • AHRQ: no evidence of clinical utility for genetic cancer tests (BioCentury)
  • 23andMe: Victim of an Overboard FDA Crackdown, or Provocateur? (Xconomy)
  • Patients Push Back on FDA Threats to 23andMe Genetic Testing Products (Patent Docs)
  • If you read just one humorously-written MedSun report today… (Elsmar Cove)
  • BME Receives FDA Clearance for the Upgraded HammerLock Intramedullary Fixation System for Hammertoe Deformities (Press)

US: Dietary Supplements

  • Inflammation Claims Language Missteps May Trigger Enforcement (Tan Sheet-$)
  • UNPA chief agrees with FDA that GMP compliance far from uniform (Nutra Ingredients)
  • Hiring an attorney early is cheaper than hiring one late, expert says (Nutra Ingredients)
  • Congress to FDA: Try again on food safety rules (The Hill)

US: Assorted And Government

Upcoming Meetings And Events

  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Early dialogue with the EMA is key to success, Regulators Say (EMA) (Pharma Letter-$)
  • Urgency over clinical trials and medtech laws leaves P&R transparency out in the cold (SCRIP-$)
  • Sativex approved for MS in Switzerland (Pharma Letter-$)
  • UK's NICE says yes to Alimera's Iluvien (Pharma Letter-$) (Pharma Times)
  • NICE final guidance gives green light to Lucentis for CNV (Pharma Letter-$)
  • Negative NICE appraisal of Pfizer's Bosulif for CML (Pharma Letter-$)
  • Third NICE consultation on Eli Lilly's Alimta in the UK (Pharma Letter-$)
  • Majority of NICE decision-making 'still centered on cost-effectiveness' says report (SCRIP-$)
  • Boots recalls cough and cold mixtures over concerns about plastic fragments (Guardian)

Asia

  • Wockhardt's Chikalthana plant hit by USFDA import restrictions (India Times) (FT-$) (Bloomberg)
  • Indian Government mulls stricter norms for patents in pharma space (India Times)
  • India Mulls Panel To Decide Ban Of Fixed-Dose Combos Banned Elsewhere (PharmAsia-$)
  • Korea's Celltrion Advances Its First Novel Therapy, Universal Influenza Treatment (PharmAsia-$)
  • Novartis Launches Japan Compliance Advisory Board In Wake Of Diovan Turmoil (PharmAsia-$)
  • No Drug Distribution Reform Measures In China, For Now: Sources (PharmAsia-$)
  • Generics the winners in Chinese regulatory overhaul? (SCRIP-$)

Other International

  • IMDRF Releases New IVD Table of Contents Guidance (IMDRF)

General Regulatory And Interesting Articles

  • Women who test negative for BRCA mutation may still have higher breast cancer risk (Fierce) (EurekAlert)
  • Global Mortality Estimates for the 2009 Influenza Pandemic from the GLaMOR Project: A Modeling Study (PLoS)
  • Study links high sodium "fizzy" medicines to raised heart risks (Reuters)

Regulatory Reconnaissance #211 - 27 November 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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