Regulatory Focus™ > News Articles > Regulatory Recon: Antibiotic Usage in US Rising Despite FDA Policies (3 October 2014)

Regulatory Recon: Antibiotic Usage in US Rising Despite FDA Policies (3 October 2014)

Posted 03 October 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Antibiotic Usage in US Rising Despite FDA Policies (3 October 2014)

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

In Focus: US

  • Antibiotics in Livestock: F.D.A. Finds Use Is Rising (NYTimes) (FSN)
  • FDA Lauded for New Antibiotic Data Reporting (Senate)
  • PhRMA, EFPIA Seeks "Regulatory Compatibility" in TTIP Negotiations (KEI)
  • Pulmonary-Allergy Drugs AdComm to Discuss Vertex sNDA for Kalydeco (FDA) (Tarius) (Pink Sheet-$) (BioCentury)
  • FDA Updates Internal IDE Review Policy (Gray Sheet-$)
  • Boston Scientific Hit With $34.6M Pelvic Mesh Judgment (Law 360-$)
  • How Technology Transfer Gets FDA Inventions from Lab to Marketplace (FDA)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • Antibiotics in Livestock: F.D.A. Finds Use Is Rising (NYTimes) (FSN)
  • FDA Lauded for New Antibiotic Data Reporting (Senate)
  • PhRMA, EFPIA Seeks "Regulatory Compatibility" in TTIP Negotiations (KEI)
  • Pulmonary-Allergy Drugs AdComm to Discuss Vertex sNDA for Kalydeco (FDA) (Tarius) (Pink Sheet-$) (BioCentury)
  • Anesthetic and Analgesic Drug Products Advisory Committee to Weigh Risk of Epidural Steroid Injections (FDA) (Tarius)
  • Risks of Long-term opioid use remain unstudied (Oncology Practice)
  • FDA Using Medicare Data Linked to NCI Databases to Look at Cancer Signals (RPM Report-$)
  • What’s Next If the FDA Holds the Line on Social Media? (Harvard BOH)
  • Cholesterol Drugs Haunted By Ghosts Of Past, Present, And Future (Forbes)
  • Drug Labels Can Provide 'Specific Intent' For Inducement (Law 360-$)

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

  • NKT's Investigational Sickle Cell Disease Agent Fast Tracked (MPR)
  • Ariad Pharma's lung cancer drug gets breakthrough therapy status (Reuters)
  • FDA Grants Durata Therapeutics a Special Protocol Agreement (SPA) for Its Phase 3 Study of Dalvance in Hospitalized Community-Acquired Pneumonia (Press)
  • Phase III diabetes data give Intarcia (and doctors, patients) options (SCRIP-$) (BioCentury)
  • Halozyme's PEGPH20 receives FDA Orphan Drug designation for treatment of pancreatic cancer (Press)
  • Eleven Biotherapeutics' drug fails to hit main goal in eye allergy trial (BioFlash)

US: Pharmaceuticals and Biotechnology: General

  • ​Tyson Stops Use Of Antibiotics At Chicken Hatcheries (Law 360-$)
  • Heroin overdose deaths double in U.S., led by addiction to prescription painkillers (CBS) (Reuters)
  • Lawmakers Probe ‘Staggering’ Price Hikes for Generic Drugs (Pharmalot)

US: Medical Devices

  • FDA Updates Internal IDE Review Policy (Gray Sheet-$)
  • Boston Scientific Hit With $34.6M Pelvic Mesh Judgment (Law 360-$)
  • Teleflex Incorporated Announces Worldwide Voluntary Recall of Hudson RCI Pediatric Anesthesia Breathing Circuits (Press)
  • August 2014 PMA Approvals (FDA)
  • Esaote Receives FDA Clearance for Its Portable MyLab Gamma Ultrasound System (Press)

US: Dietary Supplements

  • FTC Suggests Firms Keep Claim Substantiation Documents Ready For Review (Tan Sheet-$)

US: Assorted And Government

  • How Technology Transfer Gets FDA Inventions from Lab to Marketplace (FDA)
  • FDA Weekly Enforcement Report (FDA)
  • Financial Ties Between Doctors (and a Former FDA Commissioner) and Health Care Firms Are Detailed (NYTimes)

Upcoming Meetings

Ebola Outbreak

  • A Liberian doctor is using HIV drugs to treat Ebola victims. The NIH is intrigued. (WaPo)
  • Health officials clam up about effort to contain Ebola in Texas (The Hill)
  • The Efficiency of Bringing Drugs to Market Versus the Fairness of Making Drugs Accessible (PCM)
  • HHS seeks to boost ZMapp production (BioCentury)
  • Prescription for avoiding Ebola airport screening: ibuprofen (Reuters)

Europe

  • EMA removes some restrictions from its data sharing policy (AllTrials) (Outsourcing Pharma) (PMLive) (Pharma Times) (Pharmafile)
  • Italy's AIFA: Agenda for Regulatory Leadership (PharmExec)
  • EU medicines policy shift "sensible", says industry commissioner-designate  (SCRIP-$)
  • UK cost agency NICE rejects another Roche cancer drug (Reuters) (Pharmafile) (Pharma Times) (PMLive) (BioCentury)
  • Patent changes 'could boost UK as research location' (Pharma Times)
  • Draft guideline on core summary of product characteristics for human plasma-derived and recombinant coagulation factor-IX products (EMA)
  • TAVI: Direct Flow Medical wins CE Mark for enhanced heart valve delivery device (Mass Device)
  • New webpage for EDQM's Certification Division (EDQM)

Japan

  • Daiichi Sankyo Submits Cravit sNDA in Japan (Press)

Canada

  • Sanofi to roll out quadrivalent flu jab in Canada amid GSK manufacturing woes (Fierce)

Other International

  • Turkey aims to save $175m via 'base price' reimbursement (SCRIP-$)

General Regulatory And Interesting Articles

  • New Drug-Delivery Capsule May Replace Injections (Press) (MedGadget)
  • NSAIDS users see an increased risk of venous thrombosis, study shows (Pharm Journal)
  • Fecal microbiota transplantation: from practices to legislation before considering industrialization (PubMed)

Regulatory Reconnaissance #413 – 3 October 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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