Regulatory Focus™ > News Articles > Regulatory Reconnaissance (15 May 2013)

Regulatory Reconnaissance (15 May 2013)

Posted 15 May 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Fraud Cases' Impact on Ranbaxy May Climb as High as $1 Billion (India Times)
  • Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients (In-Pharma Technologist)
  • Energy and Commerce Committee Meeting on ADUFA, AGDUFA and Track and Trace Bills (E&C)
  • Washington State Biosimilars Bill Reintroduced (Scout)
  • Seattle Genetics Announces Adcetris (Brentuximab Vedotin) Supplemental BLA Accepted for Filing by the FDA (Business Wire) (SCRIP Intelligence) (Pharma Times) (BioCentury)

In Focus: International

  • Time running out for testing the UK's new anti-counterfeit measures (PJ)
  • ENVI Announces it will Soon Adopt Report on the Safety and Transparency of Clinical Trials Results (ENVI)
  • Australia Begins Reforms of Medical Device Regulatory System (TGA) (TGA)
  • Testing Meds: Companies Look Overseas for Cheap Subjects (Der Spiegel)
  • Hunan To Trial Publicizing Blacklisted Pharma Practitioners Forever (PharmAsia News)

Comments? Suggestions? Shoot me an email at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Supplemental BLA Accepted for Filing by the FDA (Business Wire) (SCRIP Intelligence) (Pharma Times) (BioCentury)
  • Fraud Cases' Impact on Ranbaxy May Climb as High as $1 Billion (India Times)
  • Confusion Abounds in Elemental Impurities Testing for Pharma, Excipients (In-Pharma Technologist)
  • Washington State Biosimilars Bill Reintroduced (Scout)
  • Total recall: April and May see surge (Clinica)
  • TWi Pharmaceuticals Announces Tentative ANDA Approval for Guanfacine Hydrochloride Extended-Release Tablets (PR Newswire)
  • FDA Approves New Indication for Endo Pharmaceuticals' Opana ER (NDA #201655) (FDA)
  • Sen. Manchin: Time for FDA to Stop Stalling on Painkillers (Coal Valley News)
  • HIV Drug Development Challenge: Will Patients Accept Risk Of Cure? (The Pink Sheet)
  • Neumedicines Receives BARDA Notification of Intent to Exercise Contract Option to Continue Development of HemaMax as Radiation Medical Countermeasure (Business Wire)
  • Bayer Initiates Phase III Trial of Regorafenib in Patients with Advanced Liver Cancer (Bayer)
  • Drug Safety Oversight Board Meeting, March 21, 2013 (FDA)
  • Suit Over Novartis Drug's Bone Death Risk Heads To Jury (Law 360)
  • NYC overdose deaths from prescription painkillers up 65% (UPI)
  • Total VC Funding for the Pharma Industry Takes a Sharp Fall from Q4 2012 to Q1 2013 (PWC)
Medical Devices
  • FDA Announces Public Meeting Regarding Device Modifications (FDA Law Blog)
  • RaySearch Laboratories: RaySearch receives 510(k) clearance for RayStation® 3.5 (Business Wire)
  • Medtech Industry's Reputation Has Improved, PatientView Survey Finds (Medtech Insider)
  • Vestakeep Peek-Based Spinal Implant Receives FDA 510(k) Approval (Business Wire)
  • Bard Whistleblower Awarded $10.1 Million (NWC)
Assorted and Government
  • Energy and Commerce Committee Markup on ADUFA, AGDUFA and Track and Trace Bills (E&C)
  • Government report finds regulations have spiked under Obama (The Hill)
  • Merck execs' bogeymen: Animal-rights, disease activists, plus laid-off workers (Fierce Pharma)
  • Senate Health Committee Members Praise HHS Response to Avian Flu Threat (Congress)
  • Pharma, Trade Experts Urge Congress to Probe India's Innovation-Impinging Policies (FDA News)
  • H.R.1958: To prohibit wholesalers from purchasing prescription drugs from pharmacies, and to enhance information and transparency regarding drug wholesalers engaged in interstate commerce (Congress)
  • National Center for Advancing Translational Sciences; Request for Comment on Proposed Methods for Avoiding Duplication, Redundancy and Competition With Industry Activities (NCATS)
Warning Letters
  • (Medical Device) Shippert Medical Technologies for DMR, QSR, Design, Validation, Adulteration, Unapproved Design Changes (FDA)
  • (Medical Device/IVD) Interlab for QSR, Design Controls, Procedure Validation, Process Control Procedures, DHRs, Complaints Controls, Quality Audits (FDA)
  • (Medical Device) Electromedical Products International for Adulteration, QSR, CAPA, Design Change Controls, Lack of Cleared 510(k), Improper Claims (FDA)
  • (Medical Device) Rubimed for Adulteration, QSR, CAPA, Recordkeeping, Complaint Management, MDR, Lack of PMA/510(k) (FDA)
  • (Pharmaceutical) Juve International for Marketing an Unapproved Drug as a Juice Products (FDA)
  • (Pharmaceutical) Entrenet Nutritionals for Marketing an Unapproved, Adulterated New Drug Using Improper Claims, CGMP Deficiencies (FDA)
Upcoming Meetings and Events
  • 14-15 May 2013: E&C Committee to Markup ADUFA/ADGDUFA User Fee Bills (E&C)
  • 14-15 May 2013: E&C Committee to Markup Pharmaceutical Track and Trace Legislation (E&C)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • 17 May 2013: NCATS Meeting (NCATS)
  • 21-22 May 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 22 May 2013: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
  • 22 May 2013: CVM's New Animal Drugs for Use in Feeds Workshop (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • Time running out for testing the UK's new anti-counterfeit measures (PJ)
  • ENVI Announces it will Soon Adopt Report on the Safety and Transparency of Clinical Trials Results (ENVI)
  • Australia Begins Reforms of Medical Device Regulatory System (TGA) (TGA)
  • Testing Meds: Companies Look Overseas for Cheap Subjects (Der Spiegel)
  • Hunan To Trial Publicizing Blacklisted Pharma Practitioners Forever (PharmAsia News)
  • TGA Opens Consultation on International Harmonization of Ingredient Names (TGA)
  • Uganda grapples with paediatric vaccine shortages (IRIN)
  • Agenda for the Upcoming Pharmacovigilance Risk Assessment Committee (PRAC)
  • European Commission releases draft report on medicinal foods (EC)
  • Polish Officials Warn that Avastin May Cause Necrotizing Fascitis (PL)
  • India's CDSCO Updates its Contact Page (CDSCO)
  • US keenly watching Indian moves on compulsory licensing in pharma sector (PharmaBiz)
  • Data transparency "a very strange debate" says new Lilly head (Pharma Times)
  • Medical Device Manufacturer Devon Medical Receives CE Mark for extriCARE® Negative Pressure Wound Therapy (NPWT) System (Business Wire)
  • Elixir Medical Receives CE Mark Approval for the Fully Bioresorbable DESolve® Novolimus Eluting Coronary Scaffold System (Business Wire)
  • Bharat planning Indian submission for rotavirus vaccine (BioCentury)

General Regulatory and Interesting Articles

Regulatory Reconnaissance #67 - 15 May 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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