Regulatory Focus™ > News Articles > Regulatory Reconnaissance (1 May 2013)

Regulatory Reconnaissance (1 May 2013)

Posted 01 May 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

In Focus: International

  • Europe's regulator digs in for drug data fight (Reuters)
  • European Medicines Agency publishes final advice from clinical trial advisory groups (EMA)
  • Lack of Communication between Notified Bodies Slows Down Approval of Wireless Medical Implants (Med Tech Insider)
  • Russia may postpone restrictions on procurement of imported drugs (The Pharma Letter) ($)
  • India beefs up clinical trial monitoring system (SCRIP Intelligence) ($)

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

US

Pharmaceuticals/Biotechnology
  • Actemra Receives FDA Approval for Polyarticular Juvenile Idiopathic Arthritis (Biopharma International) (SCRIP Intelligence) (Genentech) (Roche)
  • Biotech upstart joins Big Pharma cast on high-profile 'breakthrough' stage (Fierce Biotech)
  • Aveo shares plunge after FDA review raises fears of tivozanib rejection (Fierce Biotech) (The Pink Sheet) (Boston Business Journal) (Reuters) (SCRIP Intelligence)
  • FDA Rejection of Titan's Probuphine Looks Like a Mugging (The Street)
  • FDA to Reconsider Approval of Generic BAYTRIL; Court Gives Importance to Unresolved Citizen Petition; Will the Decision Affect FDA Petition Procedures? (FDA Law Blog)
  • U.S. launch of Novo's new insulin faces long delay because of regulatory concerns (Reuters)
  • FDA Tells Delcath No Approval Without New Clinical Trial (The Street) (The Pink Sheet) (Fierce Medical Devices) (Bloomberg)
  • Why Novartis Is Downsizing Its Nebraska Plant: Quality (Pharmalot)
  • Drugmakers Get Reprieve From Medicare Cost-Cutting Board (Bloomberg)
  • FDA Panel to Consider Two Cancer Drugs on Thursday (Med Page Today)
  • Aurobindo receives FDA approval for hypertension, antibiotic drugs (DSN)
  • FDA Approves Accord Healthcare's Amlodipine Besylate (ANDA #202553), Altaire Pharmaceuticals' Oflocaxin (ANDA # 202692), Aurobindo's Quinapril HCl (ANDA #202725), Claris Lifesciences' Metoprolol Tartrate (ANDA # 078950), Teva's Dextroamphetamine Saccharate (ANDA 077488), and Lupin's Amlodipine Besylate; Valsartan (Tentative, ANDA #090245) (FDA)
  • Navidea Biopharmaceuticals Announces the U.S. Launch of Lymphoseek (FDA)
  • GSK files COPD inhaler in the US (Pharma Times) (GSK)
  • Regulatory update: Trametinib US PDUFA date extended to 3 September 2013 (GSK)
  • pSivida Corp. Announces New Iluvien PDUFA Date of October 17, 2013 (pSivida)
  • Trimel submits NDA for CompleoTRT (BioCentury)
  • Teva Loses Amgen Spying Suit Over Blood Drug Secrets (Law 360) ($)
  • Boxed warning notes risk of discontinuing Pradaxa (Cardiovascular Business)
  • Lonza Closes Ireland Site as US Manufacturing Issues Cause Increlex Shortage (Outsourcing Pharma)
  • FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death (FDA) (Med Page Today)
  • FDA Posts 20 Updated MedGuides (FDA)
  • Recall for Hospira's Piperacillin and Tazobactam for Injection, USP 40.5 grams: Precipitation or Crystallization in IV Bag or IV Line Upon Reconstitution (FDA)
  • Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit By Fenwal: Recall - Labeling Issue Identified (FDA)
  • Urgent Product Recall - Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) BLOOD-PACK Unit (FDA)
  • Class 1 Recall: GemStar Infusion System for pump shutting off without warning (FDA)
  • What OxyContin Tells Us About the Value of "Evergreening" and Patents (BIO)
  • Raptor's FDA Approval Is New Test For Orphan Drug Pricing (The Street)
Medical Devices
  • Entrepreneurs say the FDA is killing medical innovation (Venture Beat)
  • Another Device Classification Kerfuffle at FDA (MDDI)
  • Meeting Materials for the General and Plastic Surgery Advisory Panel (FDA)
  • Hacking Pacemakers: Manufacturers are still not putting security first when designing implantable medical devices (IEEE)
  • Early-stage InterValve wins FDA clearance for V8 valvuloplasty balloon catheter (Mass Device)
  • FDA clears NxStage Medical's high-flow home hemodialysis (Mass Device)
  • Urgent - Medical Device Recall - Trima Accel Automated Blood Collection System (FDA)
  • Judge Dismisses Lawsuit Against Smith & Nephew (Medical Devices Summit)
  • Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Devices; Inspection by Accredited Persons Program (FDA)
Assorted
  • Group Calls for Removal of Top Bioethics Official (POGO)
  • FDA Debars Ashley Brandon Foyle for Selling Misbranded Drugs (FDA)
  • Young Girl Receives Lifesaving Windpipe Transplant Made From Her Stem Cells (TIME) (Today Show)
  • Boston Marathon bomb amputees offered prosthetics free of cost (Reuters)
Warning Letters
  • (Tissue) Musculoskeletal Transplant Foundation for Sterility Problems (FDA)
  • (Medical Device) Glottal Enterprises for MDR, Misbranding, QSR (FDA)
  • (Medical Device) MEDICAMAT S.A. for Non-similarity of device to predicate, QSR (FDA)
  • (Dietary Supplement) Sunset Natural Products Inc for Basically Every Violation Possible During an Inspection (FDA)
  • (Dietary Supplement) Hillestad Pharmaceuticals for CGMP, Identity/Purity Testing (FDA)
  • (Dietary Supplement) Corol Rock Man for Trying to Pass of Sildenafil Analogues as Supplements (FDA)
  • (Homeopathy) Natural Medicine Associates for Inappropriate Advertising of Homeopathic Products as New Drugs (FDA)
Government and Budget
  • H. R. 1528: To amend the Controlled Substances Act to allow a veterinarian to transport and dispense controlled substances in the usual course of veterinary practice outside of the registered location. (Congress)
Upcoming Meetings and Events
  • 29 April 2013: Accessible Medical Device Labeling in a Standard Content and Format (FDA)
  • 29 April 2013: Meeting of the Risk Communication Advisory Committee (FDA)
  • 29 April 2013: Margaret Hamburg to Appear at Milken Institute Conference on 'The Promise of the Bioscience Century' (Milken)
  • 30 April 2013: Meeting of the Risk Communication Advisory Committee (FDA)
  • 2 May 2013: Meeting of the Oncologic Drugs Advisory Committee (FDA)
  • 2 May 2013: Meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 3 May 2013: Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (FDA)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • Europe's regulator digs in for drug data fight (Reuters)
  • EMA's Guido Rasi: Time for a New Approach on Clinical Data (Financial Times)
  • European Medicines Agency publishes final advice from clinical trial advisory groups (EMA)
  • Lack of Communication between Notified Bodies Slows Down Approval of Wireless Medical Implants (Med Tech Insider)
  • Procedural advice on the submission of variations for annual update of human influenza inactivated vaccines applications in the centralised procedure (EMA)
  • India beefs up clinical trial monitoring system (SCRIP Intelligence) ($)
  • India's drugs head: 'Still keen on clinical trials' (SCRIP Intelligence) ($)
  • Russia may postpone restrictions on procurement of imported drugs (The Pharma Letter) ($)
  • NICE boosts support for innovative ideas (NICE)
  • Ghana FDA to open more outlets at border areas (Ghana Web)
  • Israeli Bill to fine drug firms for lack of translation (Jerusalem Post)
  • Australia's TGA Warns About 'BSN Hyper Shred Capsules,' Contains Three Prescription Drugs (TGA)
  • Intas Pharmaceutical launches low cost drug 'Mabtas' for cancer treatment (India Times)
  • St. Jude gains CE mark for quadripolar CRT pacer (Fierce Medical Devices)

General Regulatory and Interesting Articles

  • Real World Data Becoming Key to Drug Approval (Eye for Pharma)
  • Genentech Employee Detained After Flight for Not Flushing Toilet (Philadelphia Inquirer)
  • Merck's HPV Vaccine May Protect Girls With Fewer Doses (Bloomberg)
  • Data Published in Prenatal Diagnosis Demonstrate Panorama's Ability to Accurately Detect Chromosomal Abnormalities (Business Wire)
  • Breast augmentation may hurt breast cancer survival (UPI)

Regulatory Reconnaissance #57 - 1 Mayl 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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